According to its web site, U.S. Pharmacopeia is an official public standards-setting authority for all prescription and over-the-counter medicines and other health care products manufactured in the United States. It is a non-governmental, not-for-profit public health organziation staffed by independent, volunteer experts.

USP Chief Executive Officer Roger L. Williams, M.D., was quoted as saying, “Stronger methods for detecting contaminants have been thoroughly assessed and incorporated into the new test methods, and the new physical reference standards are specific to these methods.”

According to the Huliq News report, these newest changes in standards were the topic of discussion at the third International Heparin Workshop, which was held at USP headquarters in Rockville, Maryland, this summer. The Workshop was co-sponsored by USP, the British National Institute of Biological Standards and Control (NIBSC), and the European Directorate for the Quality of Medicines (EDQM).

It is hoped the upgraded standards will improve patient and physician confidence in heparin products.

More information is available at http://www.usp.org/hottopics/heparin.html.

SOURCE: Heparin Recall › USP updates standards for heparin

POGO is an independent nonprofit group that investigates and exposes corruption and other misconduct in order to achieve a more effective, accountable, open and ethical federal government. The organization has spoken out previously about the FDA and its handling of contaminated food and drugs, such as the tainted heparin scandal of 2007. Now it is asking questions about the contaminated pre-filled heparin and saline syringes manufactured and sold by AM2PAT.

In a letter to FDA commissioner Margaret A. Hamburg, the organization said the FDA missed chances to act before a contaminated lot of 74,000 syringes were shipped by AM2PAT to hospitals and health care centers. Earlier this year, two officials with AM2PAT were sentenced to prison after pleading guilty to crimes related to the contamination.

“Why did the FDA fail in its duty to keep a dangerous medical product, AM2PAT’s syringes, off the market?” asks POGO in its letter. “We believe that part of the reason is a culture within the FDA that habitually maintains a relationship with manufacturers that is too collegial and too tolerant. There is a reluctance by the FDA to take corrective action stronger than a Warning Letter, even when stronger action is clearly indicated, as it was at several points in the history of the AM2PAT case. There is an additional reason for the FDA’s failure: the grossly inadequate resources available to the FDA for inspection and enforcement. This is mainly a budgetary problem that can, of course, be solved only by the White House and Congress.”

POGO says that the FDA knew of AM2PAT’s failures for more than a year but has issued no public statement about the failures. “The silence on the part of the FDA officials would by itself indicate the need for an investigation and report by the Inspector General.”

SOURCE: Heparin Recall › Watchdog group pressures FDA about contaminated syringes

Investigators now know that the pre-filled heparin and saline syringe Fullerton used was part of a contaminated lot that has since been linked to at least four deaths and 162 illnesses. And that lot could have and should have been prevented from being shipped to hospitals by the Food and Drug Administration (FDA).

Months before the syringes were shipped out, the FDA received reports about debris in syringes filled with heparin and saline distributed by drug manufacturer AM2PAT, yet the agency didn’t follow up on the complaints until 2007 after the reports of deaths and illnesses following use of the syringes. Reports from 2007 inspections show that investigators found a “gummy brown” substance on the syringe-filling machine. The plant was closed in January 2008.

Consumer advocates say the FDA should have acted faster and more aggressively to prevent the contamination of the pre-filled syringes at AM2PAT. Congress, too, has been critical of the agency for not properly or adequately inspecting food and drugs that are distributed to American hospitals and health care centers, and are pushing for better inspection standards within the agency.

Source: Pro Publica

SOURCE: Heparin Recall › FDA should have acted faster to prevent contamination

Bian Zhenijia, director of the drug safety supervision department of the State Food and Drug Administration (SFDA), urged companies to be more responsible when dealing with foreign suppliers.

“The problem lies in the fact that some overseas companies have an implicit deal with underground factories or illegal manufacturers in China, so the product involved has problems,” Bian said at a press conference.

China’s pharmaceutical industry is poorly regulated and several deaths and illnesses have been blamed on contaminated medications produced there. Last year, heparin manufactured in China was linked to more than 80 deaths and hundreds of illnesses in the United States. The blood thinner was later found to have been contaminated with a heparin-mimicking substance called oversulfated chondroitin sulfate, or OSCS. Heparin is derived from pig intestines, which are often produced by unregistered China businesses.

“I do not agree with what the foreign media say. The Chinese government has always paid a lot of attention to cracking down on fake drugs,” Bian told a news conference. “If the international community can give us information on fake drugs, we will resolutely investigate. There is no ambiguity about this.”

More than 300,000 cases of unlicensed drugs and medical products were distributed in 2007, according to SFDA.

Sources:
Associated Press
Reuters

SOURCE: Heparin Recall › China says tainted drug blame should fall on foreign suppliers

“As orthopedic surgeons, we look very critically at safety; we look very critically at efficacy. I think it is fair to say, if we consider those to be equal and the dosing schedule is equal, (and) they are both once-a-day, then it comes down to cost,” Richard J. Friedman, M.D., was quoted in the publication. “But we are looking (at) safety first and efficacy afterward.”

The topic, spurred by positive Food and Drug Administration (FDA) advisory committee reviews of rivaroxaban, was discussed recently at the 76th annual meeting of the American Academy of Orthopaedic Surgeons. Rivaroxaban, made by Bayer and marketed in other countries as Xarelto, is just one of many anticoagulants in development and expected to be on the market in the next one to three years.

Heparin is an injectible used in hospitals because it is easier to control than Coumadin, also known as warfarin, which requires close monitoring and frequent blood tests. Rivaroxaban is an attractive alternative because it comes in a pill and doesn’t require constant monitoring. If approved by the FDA, Rivaroxaban will be marketed by Ortho-McNeil Pharmaceuticals.

“Often in orthopedics, even the best of folks take a long time to incorporate and change practice patterns,” said Fred D. Cushner, M.D. “The big question is, who is going to switch? … This is debatable, but my personal opinion is the injectables will probably be the first to go.”

SOURCE: Heparin Recall › Surgeons hopeful about new alternatives to heparin

Announcement of the deaths and illness at Beebe Medical Center in Lewes, Delaware, raised immediate concern at the hospital, which promptly notified the FDA and Baxter. The incidents were far too similar to the 2007 heparin scandal in which more than 80 Americans died and hundreds more became ill after receiving doses of Baxter’s heparin. An investigation found some lots of heparin manufactured in Baxter’s China factory were contaminated with a heparin-like substance called over-sulfated chondroitin sulfate, or OSCS.

Both Baxter and the FDA investigated the Beebe incidents. Earlier this week Baxter announced its investigation found no OSCS contaminate in the heparin supplied to Beebe. It also said the heparin used by Beebe was manufactured in its Ohio plant, not the China facility.

But the mystery about the deaths and illness at Beebe still remains. A Baxter spokesperson said that following the national guidelines for drugs like heparin does not guarantee that there will be no problems with the medication.

“Even when those protocols are followed, bleeding at a site, including intercranial bleeding, can occur – especially in high-risk patients, which is an established side effect of all anticoagulant therapies,” said Erin Gardiner with Baxter. “Our responsibility is for the safety of the product.”

Source: Delmarva Media Group

SOURCE: Heparin Recall › FDA clears Baxter in deaths following heparin injections

Two deaths and one illness earlier this month following the injection of heparin in patients at a Lewes, Delaware, hospital sent chills through the nation. Could this be a repeat of the deadly contamination that harmed so many in 2007? The vials of heparin were traced back to Baxter, however these doses were manufactured in Ohio, not China, the drug maker contends.

Last year’s OSCS contaminant caused victims to suffer severely low blood pressure. This new reaction involves intracranial bleeding. Investigations by both Baxter and the Food and Drug Administration (FDA) followed and early findings indicate there is no trace of OSCS in the heparin used. Now Baxter says it is confident that the events at the Delaware hospital were “isolated, institution-specific issues, unrelated to the quality of Baxter’s heparin premix product,” a Baxter spokesperson told the Reuters news organization.

According to Baxter, it obtained samples from the lot in question as well as lots produced before and after the lot in question. Testing on those lots confirmed that the product’s formulation was within specifications and met all requirements. The FDA backed up Baxter’s contention: “We don’t see a quality problem with the product,” an FDA spokesperson said.

SOURCE: Heparin Recall › Baxter says it’s not responsible for recent heparin deaths, illness

All three incidences occurred at the Beebe Medical Center in Lewes, Delaware, and all three were given heparin supplied by Baxter, the same drug company at the center of last year’s contaminated heparin scandal. That heparin, which killed more than 80 people and injured hundreds more, was manufactured in China. The latest batch was manufactured in Ohio.

The heparin in question involves premixed intravenous bags of heparin whereas the previous heparin, which was later found to have been contaminated with a heparin-mimicing substance called over-sulfated chondroitin sulfate (OSCS), involved vials of the medicine and drug-coated medical devices.

The symptoms suffered from the newest victims involved intracranial bleeding; the previous deaths and illnesses were caused by severely low blood pressure. Immediately following the adverse reactions, the hospital contacted Baxter, which immediately contacted the FDA.

Both Baxter and the FDA sent medical teams to Delaware and the FDA took samples of the heparin for testing. “As far as we can determine at this point, it appears to be an isolated incident,” says FDA spokewoman Karen Riley.

Baxter has tested for but not found the contaminant OSCS to be in the batches of heparin taken from Beebe Medical Center. Baxter insists the heparin used on the patients who became ill at Beebe was not manufactured in China but in North America.

SOURCE: Heparin Recall › New deaths, illness following heparin use spark FDA investigation

She already has Senator Edward M. Kennedy’s support. “Her expertise is valuable for problems we now face, such as combating food-borne illness, cooperating with other agencies to address the new flu outbreak and drug-resistant diseases, and protecting our food and drug supplies,” Sen. Kennedy said in a statement for the Health, Education, Labor, and Pensions Committee hearing.

If confirmed, one of Dr. Hamburg’s many priorities will be to detangle the mess left behind from last year’s contaminated heparin scandal, in which batches of tainted heparin manufactured in China made their way into the United States. Those bad batches killed more than 80 people and sickened hundreds more. An investigation resulted in the FDA’s admission that it did not have the resources or the funding to adequately inspect foreign food and drug manufacturing companies.

The agency’s handling of the heparin scandal is currently under review by the Government Accountability Office, and congressional leaders are not letting up on their insistence that the FDA make better provisions to ensure the food and drugs imported into the US are safe.

“It is abundantly clear that the agency needs strong, new leadership to improve morale and make it once again the world class agency that Americans can trust to protect the health of their families,” Sen. Kennedy wrote. “I’m very pleased, therefore, that President Obama has nominated Dr. Margaret Hamburg to lead the FDA as its new Commissioner.”

SOURCE: Heparin Recall › Obama’s pick for FDA commissioner wants to restore trust in agency

Anticoagulants are often administered to patients before undergoing some surgeries and medical procedures to reduce the risk of life-threatening blood clots. Lovenox has been touted as an effective replacement for the blood thinner heparin in patients undergoing abdominal surgery.

Heparin carries a laundry list of side effects such as nausea, vomiting, abdominal pain, diarrhea and low blood pressure. Concerns about heparin flooded the media last year with cases of accidental overdoes and shipments of tainted batches of the blood thinner imported from China. Both incidences caused patients serious injury or death.

The contaminated heparin scandal in particular created an urgency among consumers, the medical community and pharmaceutical companies to find safer alternatives to the commonly used blood thinner.

Momenta chief executive officer Craig A. Wheeler said in the conference call that the FDA continues to review its Abbreviated New Drug Application (ANDA) process for M-Enoxaprin. ANDA is the FDA’s Center for Drug Evaluation and Research Office of Generic Drugs review and ultimate approval process of a generic drug.

Once approved, an applicant may manufacture and market the generic drug product to provide a safe, effective, low cost alternative to the American public. “We are in regular communication with the agency and responding to their questions as they arise,” Wheeler said.

Wheeler referred to the “global contamination issue” with the heparin supply and the FDA’s plant inspections of Chinese suppliers of heparin, adding that the companies who supply heparin to Momenta’s partner distributor Sandoz for the manufacture of M-Enoxaprin have all been inspected by the FDA.

While the company has no indication that the inspections raised concerns with the FDA, Wheeler said “Any disruption in the heparin supply has the potential to impact our supply chain.” As a result, the company will diversify its sources of heparin and closely monitor the supply chain.

Momenta hopes to launch M-Enoxaparin in 2009 provided the ANDA is readily approved by the FDA.

Source:
Seeking Alpha

SOURCE: Heparin Recall › FDA approval for marketing generic Lovenox expected

Rep. Joe Barton

The FDA has previously claimed the raw heparin originated from a manufacturing company in China and was purposefully contaminated with a man-made chemical, over-sulfated chondroitin sulfate, OSCS. The Chinese government disagrees.

Barton, a ranking member of the House Energy and Commerce Committee, has long championed the effort to resolve the heparin scandal by scrutinizing the FDA’s investigation into the case and the subsequent recall. He has previously argued that the agency misrepresented deaths tied to the heparin and didn’t thoroughly investigate the matter. He also has demanded answers on why the FDA took six months to seize lots of the contaminated heparin from an Ohio agency that still had the tainted drug in stock.

In his latest inquiry, Barton wants to know if the FDA has tracked the contamination back to the source. He also asked what action the Chinese government has taken in the matter and whether anyone in China has been held accountable.

Products imported from China have been in the spotlight in recent years as reports of more tainted foods, drugs and toys have entered the U.S. and injured people. The FDA has been working to expand its inspections of foreign imports in part by opening offices overseas. The first of these offices opened late last year in China.

SOURCE: Heparin Recall › Congressman demands answers on tainted heparin scandal

Letters sent by the FDA to Qingdao Jiulong Biopharmaceuticals Co. Ltd. and Shanghai No. 1 Biochemical & Pharmaceutical Co. Ltd., says that during inspection of the plants in 2008, the agency “uncovered untrue statements and information by your firm to the agency.”

In late 2007 the FDA began receiving reports of patients experiencing severe reactions after receiving injections of the blood thinner heparin. An investigation found that batches of heparin manufactured in China had been contaminated with oversulfated chondroitin sulfate (OSCS), a material that is difficult to immediately identify as it mimics heparin. The tainted blood thinner killed more than 80 Americans and sickened hundreds more before batches of the medication were recalled.

In the letters to the Chinese drug suppliers, the FDA said that although some shipments of heparin were quarantined, the drug companies did allow 19 lots to be shipped to the U.S. The agency warned that it can refuse to grant new drug applications or allow shipments to unload.

The FDA, which later admitted it did not have sufficient resources to fully inspect foreign food and drug manufacturers, has come under fire for its handling of the contaminated heparin scandal. As a result, the FDA has stepped up its efforts by opening inspection offices in foreign countries to oversee the quality of goods imported into the U.S. The first offices were placed in China with plans to have four permanent inspectors in China by mid summer.

SOURCE: Heparin Recall › FDA accuses Chinese companies of lying about role in heparin scandal

It wasn’t until then that Martin learned the syringe he had used on his young son was part of a recalled batch that was found to have been contaminated at the manufacturing plant AM2PAT. The tainted syringes killed five people and sickened at least 100 more before the Angier plant was closed. The company’s “clean room” was found to be a frightful mess.

Last month, two AM2PAT managers pleaded guilty to federal fraud and a warrant is out for AM2PAT president Dushyant Patel, who is still at large.

Knowledge of the recall did little to put Martin’s mind at ease. He wants answers from the company, the distributor of the syringes, and the Food and Drug Administration (FDA).

“I just felt, why? Why didn’t somebody stop this?” he told media. “Not only did they hand me a loaded gun, they enabled me to pull the trigger on my own son.”

An FDA warning letter to the plant in 2005 reported no major safety violations. However, an FDA spokesperson says in August 2007 the company began producing the syringes at a “dramatic rate” and that was when quality began to slip.

The FDA was notified by the Centers for Disease Control and Prevention about the adverse events reported, and within five days the FDA had closed down the plant for manufacturing violations. The FDA also contends that “evidence of a casual link between the AM2PAT product” and the infections was “never conclusively established.”

The FDA’s claims don’t sit well with Martin, who says he will pursue legal action.

Source: WRAL

SOURCE: Heparin Recall › Father blames FDA for not taking precautions to protect son

Blood tends to pool in the atrial chamber of individuals with atrial fibrillation, which can lead to clotting and an increased risk for strokes. Patients with atrial fibrillation are generally treated with blood thinners to help prevent blood clots from forming.

However, blood thinners like heparin can cause serious bleeding episodes and allergic reactions. Alternatives to long-term use of blood thinners has many cardiologists taking notice.

“The findings from this clinical trial are very impressive,” said Dr. Gregg C. Fonarow, professor of cardiology at the University of California, Los Angeles. “Treatment with this novel device will be very attractive and provide patients with atrial fibrillation effective, long-term protection from stroke and systemic embolization without the bleeding risks associated with (blood thinners).”

The PROTECT-AF Trial, which involved 707 patients with a type of atrial fibrillation, showed that patients who had the device had a 32 percent lower risk of stroke and cardiovascular death compared with those on blood thinners. The study also found fewer complications with the implanted device compared to the use of blood thinners.

A Food and Drug Administration (FDA) advisory panel will meet in April to consider the sale of the device in the United States.

Source:
Eflux Media News

SOURCE: Heparin Recall › Heart device may eliminate need for heparin, warfarin

The label changes include modifications to the Warnings, Precautions and Adverse Reactions sections of Heparin Sodium in 5% Dextrose Injection and Heparin Sodium in 0.9 % Sodium Chloride Injection.

The labeling changes in part were spurred by the much-publicized overdosing of actor Dennis Quaid’s newborn twins, who nearly died in 2007 when they were accidentally given 1,000 times the intended dose of the blood thinner. The Quaid’s case is just one of many cases where health care workers claimed to have confused high-dose and low-dose heparin. Some argue that the two bottles can be easily confused.

Heparin is generally used when a patient – adult or infant – receives fluids through a central line to prevent a blood clot from forming, which could eventually grow and break off and kill a patient. But if the blood is too thin, it puts the patient at risk for life-threatening bleeding or hemorrhages, including in the brain.

Heparin has seen its fair share of the spotlight lately. Last year more than 80 Americans died and hundreds more were sickened after receiving doses of heparin made at Baxter International’s China plant. An investigation found that lots made in that plant were contaminated with oversulfated chondroitin sulfate (OSCS). The contaminant can cause serious allergic reactions and even death.

SOURCE: Heparin Recall › FDA announces labeling changes for heparin

Rivaroxaban, a pill marketed in Europe as Xarelto, showed to be more effective than the anticoagulant heparin, while presenting no more side effects than heparin. Side effects of heparin and rivaroxaban include the risk of internal bleeding. Another benefit of rivaroxaban is that it does not need constant monitoring like another popular blood thinner, warfarin. Heparin is administered intravenously while warfarin is a pill taken orally.

Pharmaceutical companies have long been working on safer and easier alternatives to heparin and warfarin, especially since the tainted heparin scandal last year where more than 80 Americans died and hundreds more were made sick after receiving injections of batches of heparin that had been laced with oversulfated chondroitin sulfate (OSCS), a contaminant that mimics heparin but can cause serious allergic reactions in humans.

The FDA is expected to make a decision whether to approve rivaroxaban by May 28. If approved, rivaroxaban would be the first oral blood thinner approved since the FDA approved warfarin in 1954, according to Forbes.

“We appreciate the thoroughness of the advisory committee’s review, and we will continue to work with the FDA as they finalize their review,” Dr. Peter DiBattiste, vice president of Johnson & Johnson Pharmaceutical Research and Development, said in a prepared statement.

SOURCE: Heparin Recall › FDA panel recommends agency approval of heparin alternative

Sharfstein made headlines in 2007 when he convinced the FDA to restrict the use of over-the-counter children’s cough and cold medicines based on evidence they can cause serious health complications and even death in children.

If there is one government agency that needs overhauling, it is clearly the FDA. The agency has been under scrutiny for the past few years over contaminated food and drug products that have harmed and even killed Americans.

The agency is still feeling the repercussions from the tainted heparin scandal. Last year more than 80 Americans died and several more were made seriously ill after receiving injections of specific batches of the blood thinner that had been manufactured in a China plant. Those batches were found to have been contaminated with oversulfated chondroitin sulfate (OSCS), a contaminant that mimics heparin but can cause serious allergic reactions.

Following the revelation, the FDA admitted that it simply did not have manpower to properly inspect foreign food and drug manufacturing plants. Since then the FDA has taken measures to step up its inspections by opening field offices overseas. The first three offices opened late last year in China.

The FDA employs more than 11,000 employees and an annual operating budget of $2 billion.

SOURCE: Heparin Recall › Hamburg, Sharfstein to head troubled FDA

Even on the campaign trail, Obama’s camp said it would support the plan but that there would have to be measures in place to ensure the FDA was properly inspecting the plants where drugs are being manufactured.

After all, it was just one year ago that hundreds of people became ill and more than 80 died after receiving injections of the blood thinner heparin that was later found to have been contaminated at pharmaceutical giant Baxter International’s manufacturing plant in China.

The FDA later admitted that it simply didn’t have the manpower to inspect all foreign food and drug manufacturing plants and thus couldn’t ensure the safety of those products. Late last year, the agency began placing food and drug inspectors to oversee the safety of foods and drugs imported into the U.S. The first three offices were opened in China.

Allowing Americans to purchase their drugs from foreign countries can provide a tremendous savings to consumers, but some lawmakers say that it is too risky a gamble. At a hearing of the Senate Finance Committee, Kansas Republican Pat Roberts asked the White House if it was in favor of first establishing some controls before moving forward with the importation plans. “Would you also agree that, if such a proposal were to move forward, we should demand that any drug imported into the U.S. meet the same high safety and efficacy standards of our FDA including bioequivalency standards?” he asked.

White House budget director Peter Orszag answered by simply saying, “Yes.”

SOURCE: Heparin Recall › Lawmakers debate safety of importing drugs

Heparin is routinely given to patients before certain types of surgery and prior to treatments such as kidney dialysis to prevent blood clots from forming. Clots that do not naturally dissolve can travel through the blood stream and end up in the brain, causing stroke or in the lungs resulting in a pulmonary embolism.

Heparin is produced naturally by most animals, including humans, but most heparin used today is derived from pig intestines. China has become a popular location for manufacturing heparin because it has a much larger pig population. It is somewhat inexpensive to produce, however, ensuring the safety of drugs manufactured overseas has been a challenge for the Food and Drug Administration (FDA). Just last year, more than 80 Americans died and hundreds more were sickened after they received injections of specific batches of heparin that were manufactured in China. That heparin was later found to have been contained with oversulfated chrondroitin sulfate (OSCS). As a result, researchers have been working to find safer alternatives to heparin.

Liu, whose Recomparin research was published online in the Proceedings of the National Academy of Sciences journal last November, says he is also looking into customizing heparin for other uses, such as a treatment for small-cell lung cancer.

SOURCE: Heparin Recall › Researcher awarded NIH grant for development of synthetic heparin

Last March, after more than 100 people died and hundreds more were sickened after being given the tainted heparin, an investigation found that heparin manufactured in Baxter’s China plant had been contaminated with oversulfated chondroitin sulfate (OSCS). OSCS mimics heparin and can cost substantially less to produce – $9 compared to $900. However, OSCS can cause serious allergic reactions which can lead to death.

The lawsuit states, “The recalled heparin was adulterated, misbranded, defective, unreasonably dangerous and unfit for its intended uses. Baxter placed tens of thousands of patients, including the Plaintiffs, at unnecessary risk of serious injury and/or death.”

It also claims Baxter wrongfully allowed the heparin to be placed on the market and “breached its express warranties that heparin had no dangerous side effects and that its ingredients were manufactured in a plant in accordance with FDA regulations,” according to the report.

The six-count suit seeks a judgment of more than $300,000 plus costs and other relief.

SOURCE: Heparin Recall › Class action lawsuit filed against Baxter over tainted heparin scandal

However, an FDA spokesperson says no details were available on those “new efforts” the agency will undertake to ensure quality control, though a spokesperson with the Department of Health and Human Services, which oversees the FDA, says more information will be available when Obama releases the more detailed budget in April.

The Bush administration largely opposed the idea because of safety concerns. One cannot soon forget the toll tainted heparin took on the U.S. just last year. More than 80 people died and hundreds more were sickened when vials heparin imported from a China manufacturing plant were found to have been contaminated. FDA admitted then that it didn’t have sufficient staff to properly inspect all food and drug manufacturing plants on foreign soil.

Countries such as Canada sell medicines for much less than in the United States because the government helps control prices. Critics of importation say that buying drugs from foreign countries would leach vital funds from the U.S. drug industry that otherwise would be used to research new therapies and innovations.

In the past several months, the FDA has stepped up quality control measures by setting up offices overseas to inspect food and drugs being imported into the U.S. The first offices were placed in China.

SOURCE: Heparin Recall › New budget supports plan for importation of drugs

AM2PAT is now the subject of a criminal investigation. Federal investigators say the company was so focused on making profits that it did not conduct necessary safety tests and instead covered up the matter by falsifying reports to make it appear those tests had been conducted.

Earlier this week, workers at the plant pleaded guilty for their roles in the scandal and were sentenced to four years in prison. The company’s president, Dushyant Patel, faces numerous charges but has apparently fled to his native country India. If convicted, he faces up to 95 years in prison.

According to reports, the FDA received complaints that there were “orange specks,” or “yellow sediment” floating in the unopened syringes, or that the medicine inside appeared “muddy brown.” Despite the reports, which are recorded as early as November 2005, the FDA didn’t follow up on the complaints until 22 months later.

Food and drug manufacturing plants should be inspected by the FDA every two years, but many plants, such as AM2PAT have received site visits about every five years, according to a report from the Government Accountability Office. The report also shows that between 2002 and 2007, FDA inspectors visited only about 25 percent of the 5,616 registered plants each year.

SOURCE: Heparin Recall › FDA knew of tainted syringes two years before inspecting plant

The new standards were proposed by scientists with U.S. Pharmacopeia, a nonprofit public health group that sets standards for the quality, purity, strength and consistency of medicines. A spokesperson with the group says the new standards are the best as scientifically possible at this time.

The revisions for testing the popular blood thinner were first requested by the FDA when the contaminant was identified in March. The changes are expected to go into effect on August 1 and include three identification tests and screening for organic impurities.

Baxter was one of the leading manufactures of heparin, producing half of the injectable heparin sold in the U.S. and generating about $30 million in sales each year. Baxter stopped sales of heparin last year and has yet to resume selling the anti-coagulant. The company is facing numerous lawsuits from families affected by the tainted heparin.

SOURCE: Heparin Recall › Scientists propose new testing standards for heparin

Such is the case with the blood thinner heparin, which last year was the focus of much scrutiny when 80 Americans died and hundreds more were sickened after receiving doses of heparin manufactured in China. An investigation found that batches of heparin manufactured in Baxter International’s China plant had been contaminated with oversulfated chondroitin sulfate (OSCS). OSCS mimics the appearance of heparin but cause adverse reactions and even death.

Years ago most drugs were manufactured in the U.S., but over the years those operations have moved overseas – in particular, to Asia – where labor, construction, regulatory and environmental costs are lower. The FDA also inspects domestic plants far more often than foreign ones, which also adds to pharmaceutical companies’ production costs.

Following the heparin contamination last year, the FDA admitted that it was not sufficiently staffed to inspect all foreign offices. Thus, the agency has since begun to set up offices in foreign countries. To date, offices have been placed in China and India. The FDA also launched a voluntary two-year “Secure Supply Chain” pilot project to help promote the safety of drugs and active drug ingredients made outside the U.S.

SOURCE: Heparin Recall › Lawmakers call for rule requiring drugs be made in U.S.

Last year the FDA announced it would place more than 60 food and drug regulators worldwide in an effort to keep unsafe drugs out of the country. Late last year the first offices opened in China, a country whose products have made headlines over the past several months for harming hundreds of thousands of people around the globe.

Aside from lead paint on toys, faulty cribs, tainted pet food and contaminated milk, China was also the site where investigators found a drug manufacturing company had contaminated batches of the blood thinner heparin with oversulfated chondroitin sulfate (OSCS). OSCS mimics the appearance of heparin but can cause adverse reactions and even death.

Before the contaminate was detected, the OSCS-laced heparin was imported into the United States, where it was administered to patients. The tainted heparin killed more than 80 people and sickened hundreds more.

The FDA reports that India is the fourth largest exporter of drugs and biologics into the U.S., according to Med Page Today.

The FDA also announced last week that it will launch a voluntary two-year “Secure Supply Chain” pilot project to help promote the safety of drugs and active drug ingredients made outside the U.S. The program is designed to assist the FDA in its efforts to prevent the importation of drugs that do not comply with applicable FDA requirements.

SOURCE: Heparin Recall › FDA opens offices in India to help oversee drug importation

Dr. Torti joined the FDA in May, just as the tainted heparin scandal was still brewing at the agency. Dr. Von Eschenbach recruited Dr. Torti to “help bolster the agency’s scientific infrastructure,” according to the news story.

Last year more than 80 Americans died and hundreds more became ill after they received injections of the blood thinner heparin. An investigation revealed that batches of heparin manufactured in China had been contaminated. The FDA later admitted it was not sufficiently staffed to inspect all foreign food and drug manufacturing plants.

Dr. Torti bypassed Dr. Janet Woodcock for the interim FDA commissioner post. Dr. Woodcock was the FDA’s deputy commissioner for scientific and medical programs, chief medical officer, and acting director of its Center for Drug Evaluation and Research. She had been favorite choice for the post by pharmaceutical manufacturers. Congressional critics claimed she was too closely tied to pharmaceutical groups and cited serious drug safety issues under her watch, including the tainted heparin scandal.

SOURCE: Heparin Recall › Torti named interim commissioner of FDA

The program is designed to assist the FDA in its efforts to “prevent the importation of drugs that do not comply with applicable FDA requirements by allowing the agency to focus its resources on foreign-produced drugs that fall outside the program and may not be compliant,” according to the FDA press release.

“This initiative creates incentives for drug makers to develop and maintain secure supply chains,” said Deborah Autor, Director of the Office of Compliance in FDA’s Center for Drug Evaluation and Research, in the press release. “This is one of several agency initiatives to enhance drug product safety.”

The pilot program compliments the agency’s recent placement of offices in foreign countries to oversee quality control standards of foods and drugs imported into the U.S. The efforts likely stem from scrutiny the agency received last year after batches of heparin produced in China were found to have been contaminated. The tainted heparin killed more than 80 people and sickened hundreds more before an investigation revealed that the heparin was most likely contaminated during manufacturing at Baxter International’s China plant. The finding led to an FDA recall of specific lots of heparin.

In the months following the heparin scandal, the FDA has come under fire from lawmakers and advocacy groups for not adequately inspecting foreign food and drug manufacturing plants, and for mishandling the contaminated heparin investigation.

SOURCE: Heparin Recall › FDA launches pilot project to oversee foreign drug products

The Quaids also sued Baxter Healthcare Corp. over the packaging and labeling of its high-dose and low-dose heparins, arguing the two bottles are easily confused. Other cases of heparin overdose have been reported and linked in part to the confusing packaging. The Quaid’s lawsuit against Baxter was dismissed on jurisdictional grounds because the event occurred in California.

Baxter was no stranger to the spotlight in 2008, facing numerous lawsuits most notably for the tainted heparin scandal earlier in the year. More than 80 Americans died and hundreds more were sickened after receiving doses of heparin made at Baxter China plant. An investigation found that lots made in that plant were contaminated with over-sulfated chondroitin sulfate (OSCS). The contaminant can cause serious allergic reactions and even death. The FDA issued a recall on batches of Baxter’s heparin.

According to news reports, the Quaid-Cedars-Siani case indicates that Baxter may also sue Cedars-Siani for improperly administering the blood thinner to several patients at the hospital, including the Quaid’s newborn twins.

SOURCE: Heparin Recall › Quaid-Cedars-Siani lawsuit over heparin overdose finally closed

Joyce Ann Osteen filed the suit in St. Clair County, Illinois, and claims Baxer purposefully added a contaminant, over-sulfated chondroitin sulfate, or OSCS, to heparin manufactured in its China plant. The tainted heparin was distributed to the U.S., where hundreds of allergic reactions occurred. More than 80 people died and hundreds more were sickened by the tainted heparin before an investigation led to a recall of batches of heparin manufactured at Baxter’s China facility. The FDA later issued an announcement saying that the contaminant was an inexpensive and unapproved ingredient that mimics heparin.

OSCS costs only $9 to produce compared to $900 for heparin, the suit contends.

“The recalled heparin was adulterated, misbranded, defective, unreasonably dangerous and unfit for its intended uses,” the suit states. “Baxter placed tens of thousands of patients, including the Plaintiff at unnecessarily risk of serious injury and/or death.”

The suit states Osteen and the class members who purchased the heparin “suffered actual damages as a proximate result of Baxter Healthcare Corp.’s deception in that they were deprived of the benefit of their bargain.” According to the complaint, Osteen is asking the court to certify the complaint as class action. She also is seeking damages of less than $74,999 per plaintiff or class member.

SOURCE: Heparin Recall › Class action lawsuit filed against heparin manufacturer Baxter

In early December, the FDA announced that it had received information about the Innohep in Renal Insufficiency Study (IRIS) that was stopped in February because of an interim finding of increased mortality in elderly patients.

As a result, in July, the company revised the prescribing information to restrict the use of Innohep in patients 90 years of age and older. However, preliminary data from IRIS suggests that the increased risk of mortality is not only limited to patients in that age range. Study results suggest that compared to unfractionated heparin, Innohep increases the risk of death for patients 70 years and older with renal insufficiency and deep vein thrombosis (DVT), pulmonary embolism (PE), or both. The FDA suggested health care professionals consider the use of alternative treatments for patients older than 70 years of age with those conditions.

The FDA says it anticipates submission of the final IRIS study report sometime in January and will complete its review soon thereafter. Additional regulatory actions as appropriate will be considered after thorough review of all applicable data from the manufacturer of Innohep.

SOURCE: Heparin Recall › Celgene issues letter warning of limited use of heparin drug

Early in 2008, more than 80 Americans died and hundreds more were sickened after receiving injections of heparin. An investigation found that batches of heparin manufactured in Baxter International’s China facility had been tainted with a contaminant that caused severe allergic reactions in patients who received the doses. As a result, lots of heparin manufactured by Baxter International were recalled.

The Chicago Tribune story says both the FDA and Baxter International believe the heparin was “intentionally adulterated by suppliers in China.”

The tainted heparin scandal beat out other big local news stories in the Chicago Tribune’s top 10 list, including the Tribune Co.’s filing for Chapter 11 bankruptcy protection; the city reaching the final phase of competition to host the 2016 Summer Olympics; and the selling of Wm. Wrigley Jr. Co. to Mars Inc., creating the world’s largest confectionary company.

The concern over imported foods and drugs landed heparin on U.S. News & World Report’s list of top health stories. Titled, “Dubious Drugs, Tainted Foods Top 2008’s Health Stories,” the story groups the tainted heparin with salmonella-tainted jalapeno peppers imported from Mexico on its list of food and drug scares. Contaminated heparin keeps company on that list with with the FDA’s warning about over-the-counter cold meds for young children and the American Cancer Society’s announcement that for the first time since 1998, when statistics began to be compiled, the number of people who developed cancer or died from the disease has dropped.

Here’s to a happier, healthier New Year!

SOURCE: Heparin Recall › Heparin scandal makes 2008 top 10 lists

Allie recently posted a video on YouTube in light of the heparin scandal, asking “Is my insulin tainted?” Last year, more than 80 Americans died and hundreds more were sickened after receiving doses of the blood thinner heparin. An investigation found that batches of heparin manufactured at Baxter International’s China facility had been contaminated. That led to a recall, and further questions about the quality of the foods and drugs imported into the United States from foreign countries, especially China.

Demanding answers, Allie made phone calls to insulin companies and 24 hours later, reported on her results. Her first call was to Sanofi Aventis, a pharmaceutical company based in Bridgewater, NJ. Sanofi Aventis manufactures medications such as Allegra, Ambien, and Ketek as well as diabetes medications such as insulin glargine injection Lantus and insulin gluisine injection Apidra. Allie reports that she was able to speak with a customer service representative with Sanofi Aventis who informed her that the raw materials are manufactured in Germany and are “completely FDA approved and do not come from China.”

Allie compared her attempts to reach Eli Lilly and Company’s customer service as being in the “twilight zone.” Her repeated calls “during normal business hours” were either cut off or unanswered. Lilly is the 10th largest pharmaceutical company in the world and offers a variety of products. It’s diabetes products include Byetta, Gluagon and Humulin.

Allie then called Novo Nordisk, a manufacturer and marketer of pharmaceutical products and services headquartered in Denmark. Novo Nordisk offers a line of diabetes products such as insulin pens, needles and hypokits. She was told that its diabetes products are bottled in North Carolina.  Its FlexPen is manufactured in Denmark. Customer Service assured her they follow FDA guidelines and run batch tests to ensure safety.

SOURCE: Heparin Recall › Diabetic questions safety of insulin in light of heparin scandal

According to the report, the Institute of Medicine issued a statement recommending the USDA’s Food Safety and Inspection Service and the food safety activities of the FDA within HHS should be unified. The consumer groups argue that combining the two agencies would cause the dysfunctional FDA program to undermine the good work of the USDA. Thus, the groups are recommending reforming the food inspection process.

The FDA is a hot topic for the Obama administration. The agency has come under fire in recent months for its handling of contaminated foods and tainted imports. Last spring, the agency incorrectly identified the source of a salmonella outbreak to tomatoes before concluding that jalapeno peppers from Mexico were the cause.

And, earlier this month, Rep. Joe Barton, a ranking member of the House Energy and Commerce Committee questioned the FDA’s handling of the contaminated heparin scandal that caused more than 80 Americans to die and hundreds more to fall ill. The heparin was found to have been contaminated at a China manufacturing plant. After issuing a recall on the tainted heparin, the FDA admitted it did not have the staff to fully inspect all foreign food and drug manufacturing plants to ensure quality and safety of drugs imported into the United States.

SOURCE: Heparin Recall › Consumer groups, institute team up to urge FDA reform

The news is a double-blow for Europeans, not only for the 43 employees who lost their jobs, but for consumers who have expressed concerns about the quality of drugs and other products made and manufactured in China.

Products made in China have been continuously under fire for the past several months, from milk tainted with melamine to toys covered with toxic lead paint. Earlier this year lots of the blood thinner heparin manufactured in China were recalled after more than 80 Americans died and hundreds more fell ill after receiving doses of heparin. Select batches of heparin were found to have been contaminated during production at Baxter International’s China plant.

Since then, the FDA has announced plans to better track imports of food and drugs. One of its first steps was to open three offices in China to oversee quality control standards of products imported to the United States. Another 50-plus offices will be opened worldwide, though the agency says it could take years to effectively inspect all foreign facilities.

According to Bloomberg, China has more than 700 plants registered to ship drugs to the United States – more than any other country.

SOURCE: Heparin Recall › Europeans now dependent on China for Panadol, Tylenol

Last year, heparin was thrust into the spotlight after more than 80 patients who had received the blood thinner died and hundreds more became ill. An investigation to the adverse reactions found that batches of heparin manufactured in Baxter International’s China plant were contaminated with over-sulfated chondroitin sulfate (OSCS). That discovery spurred the FDA to recall lots of heparin made by Baxter International.

“Perhaps the most surprising fact that emerged in our three months of reporting on contaminated heparin ingredients from China: The U.S. government has little ability to know whether the drugs we are taking are safe or not,” Eisner points out.

Last month, the FDA vowed to step up its efforts to oversee quality control of imported foods and drugs by opening offices in foreign countries. Its first offices opened in China. The FDA plans to place more than 60 food and drug regulators worldwide over the next several months. However, the agency says it will take more than a decade to adequately inspect all foreign drug manufacturing plants.

“As a result,” Eisner writes, “doctors must take it on faith that the medicines they are prescribing are exactly what they are supposed to be.”

SOURCE: Heparin Recall › Tainted heparin may have caused death of infant

Heparin is generally used when a patient – adult or infant – receives fluids through a central line to prevent a blood clot from forming, which could eventually grow and break off and kill a patient. But if the blood is too thin, it puts the patient at risk for life-threatning bleeding or hemorrhages, including in the brain.

The Quaids also sued Baxter Healthcare Corp. over the packaging and labeling of its high-dose and low-dose heparins, arguing the two bottles are easily confused. Other cases of heparin overdose have been reported and linked in part to the confusing packaging. The Quaid’s lawsuit against Baxter was dismissed, according the Associated Press.

Baxter International has faced numerous lawsuits lately, most notably for the tainted heparin scandal earlier this year. More than 80 Americans died and hundreds more were sickened after receiving doses of heparin made at Baxter International’s China plant. An investigation found that lots made in that plant were contaminated with over-sulfated chondroitin sulfate (OSCS). The contaminant can cause serious allergic reactions and even death. The FDA issued a recall on batches of Baxter’s International’s heparin.

The Associated Press reports that the petition filed Monday in the Quaid-Cedars-Sinai case indicates that Baxter International may also sue Cedars-Sinai for improperly administering the blood thinner to several patients at the hospital, including the Quaid’s newborn twins.

SOURCE: Heparin Recall › Quaids get settlement in heparin overdose case

Franke Leon Isom of Webster, Ken., died Dec. 14, 2007, a day after he was given heparin during treatment at Woodland Dialysis Clinic in Elizabethtown. Attorneys argue that Isom received part of the 55,000 gallons of heparin that was contaminated with over-sulfated chondroitin sulfate (OSCS).

Earlier this year, a series of deaths and adverse allergic reactions from patients who had received doses of heparin led to an investigation that linked the reactions to lots of heparin made at Baxter International’s China plant. Further review found the heparin had been contaminated with OSCS during manufacturing in China. Shortly thereafter, the FDA ordered a recall. The tainted heparin is blamed for more than 240 deaths worldwide and caused hundreds more people to fall ill from allergic reactions to OSCS, such as hypotension.

The lawsuit, filed on the behalf of Isom’s estate, is one of 50 similar civil tort claims against Scientific Protein Laboratories and Baxter International, according to the news report. Attorneys argue that recalled lots of heparin were still found on hospital shelves months after the recall went into effect.

SOURCE: Heparin Recall › Another lawsuit filed in tainted heparin scandal

Heparin from another company, APP Pharmaceuticals Inc., wasn’t considered a problem, though in a letter to Congress in October, the FDA said one patient taking the APP heparin had a severe reaction that may have led to his death, according to the news report. APP responded in a letter to the congressman’s staff that the company had thoroughly reviewed the case and did not believe the patient’s death was a result of contaminated heparin.

Rep. Barton wants to know why the FDA has “no information” about whether that patient’s death was caused by the same contaminant – over-sulfated chondroitin sulfate – as was found in Baxter International heparin.

Rep. Barton has been on the FDA’s case for more than a month, questioning the agency’s handling of the heparin recall, claiming it misrepresented deaths tied to the product , arguing that it didn’t thoroughly investigate the matter, and ordering answers on why the agency took six months to seize lots of contaminated heparin from an Ohio agency.

SOURCE: Heparin Recall › Barton wants answers from FDA about heparin scandal

Von Eschenbach was appointed by President Bush in 2005 after the agency’s previous commissioner resigned due to ethical issues, the AP reports. While under von Eschenbach’s helm, the FDA has undergone scrutiny by Congress and consumer groups over issues such as the tainted heparin scandal earlier this year.

The FDA ordered a recall on batches of the blood thinner heparin made at Baxter International’s Chinese facility after some lots were found to have been contaminated with over-sulfated chondroitin sulfate. The tainted heparin killed more than 80 Americans and sickened hundreds more before the contaminant was identified and linked to the China plant.

Over the past several months the FDA continued to come under fire for its handling of the heparin recall. Last week, Rep. Joe Barton, a ranking member of the House Energy and Commerce Committee, questioned why the FDA waited six months to seize lots of contaminated heparin from Celsus Laboratories in Ohio. Last month Rep. Barton also asked the Government Accountability Office to look into the agency’s overall handling of the recall.

Despite the criticism, von Eschenbach has been favorably regarded for strengthening the agency’s international food and drug regulations, opening three offices in China last month and vowing to place more than 60 food and drug regulators worldwide to oversee quality standards of food and drugs imported to the United States.

President-elect Obama is considering a list of candidates to succeed von Eschenbach that includes Baltimore’s health commissioner, several prominent physicians, and former and current FDA officials, according to AP.

SOURCE: Heparin Recall › FDA commissioner announces plans to resign next month

Earlier this year, the FDA recalled lots of heparin manufactured in a Baxter International Chinese plant after batches were found to have been contaminated with over-sulfated chondroitin sulfate. The FDA recall was the result of an investigation into the deaths of more than 80 people and illnesses of hundreds more people after receiving doses of heparin.

CNN Money reports that the recall process is voluntary. Companies are not required to immediately comply with the FDA’s request, however FDA inspectors reportedly told Celsus Laboratories in April that its recall efforts were insufficient, and a month later followed up in a letter to the company expressing the same concerns. Last month, the FDA seized 11 contaminated lots of heparin from Celsus Laboratories.

The FDA won’t elaborate on why Celsus Laboratories’ efforts were less than satisfactory, saying its investigation into the matter is still ongoing. The agency did say that on occasion it sends safety officers to companies to conduct “100 percent effectiveness checks” to ensure they are taking proper measures to destroy the recalled products.

Rep. Joe Barton, a member of the House Energy and Commerce Committee, has been following the heparin situation and, last month, asked the Government Accountability Office to look into the matter. The congressman also wrote a letter to the FDA commissioner saying he wants to know when the agency first decided it was appropriate to seize heparin from Celsus Laboratories. He also asked for a list of all individuals involved in the decision to seize the heparin.

SOURCE: Heparin Recall › Congressman questions FDA’s slow action on heparin seizure

The Web site details the safety measures the pharmaceutical company has taken over the past several months, including enhanced labeling, unit-of-use bar codes, large lettering and color-coded bottle stoppers to help eliminate misuse of its products, which also includes injectible drugs for oncology.

APP Pharmaceuticals became the only U.S. provider of the blood thinner heparin after batches of heparin manufactured at Baxter International’s Chinese plant were found to have been contaminated. The tainted heparin killed more than 80 Americans and sickened hundreds more before the FDA pinpointed the source of contamination and issued a recall of the specific lots.

APP Pharmaceuticals has two U.S. manufacturing plants and one in Puerto Rico, however it imports its raw material from a Chinese supplier.

Heparin also was thrust into the spotlight in 2007 with the much-publicized overdosing of actor Dennis Quaid’s newborn twins. The newborns nearly died after they were accidentally given 1,000 times the intended dose. Other cases of heparin overdose have been reported and linked in part to similar packaging of high-dose and low-dose heparin.

APP Pharmaceuticals‘ safety initiative comes on the heels of new federal requirements for health care facilities that go into effect January 1, requiring health care facilities to have in place a comprehensive anticoagulation management plan in order to be accredited by the U.S. Joint Commission.

SOURCE: Heparin Recall › Drug company launches Web site to highlight safety measures

If so, Dashle will inherit a department that oversees the FDA, an agency that is rife with issues. The agency has been the subject of criticism over its handling of the tainted heparin scandal earlier this year in which more than 80 Americans were killed and hundreds more sickened after receiving injections of heparin from China.

The FDA, struggling with low staff levels, is gradually hiring more employees. It recently began placing food and drug inspectors and opening foreign offices – the first of which was in Beijing, China – in an attempt to oversee quality control of food and drugs imported into the U.S. However, hiring enough staffers to fully inspect those foreign manufacturing plants could take years.

“The people who have been doing the hiring say it will take three years to get those folks up and running and fully trained to carry out any work,” said Marcia Crosse, GAO’s director of health care, in the Federal Times story. “They’ve had to shift away from the traditional model of having other countries oversee their own pharmaceuticals. Where we may have trusted Germany to oversee its companies, the same can’t be said for China and India.”

The National Treasury Employees Union president says she is hopeful that the Obama administration will make hiring more inspectors, scientists and chemists for the agency a priority.

SOURCE: Heparin Recall › Daschle likely to inherit agency rife with issues

First, researchers noted that the evaluations were short term and that many of the studies were supported by the generic drug companies, who have a vested interest in the positive outcome of the results.

Furthermore, the story points out that generics are more likely to be made in factories in other countries where labor and overhead are far less expensive, such as India and China. In fact, China is producing more and more generic drugs and, according to the story, is expected to offer even lower prices in the future.

This should raise concerns with the general public, given the tainted heparin scandal earlier this year that killed more than 80 Americans and sickened hundreds more. That tainted heparin was traced to manufacturing plants in China and resulted in a major recall of the blood thinner.

The FDA is hoping to give more guidance on U.S. quality control standards on imported food and drugs by opening offices and placing regulators in foreign countries. The first office opened in Beijing last month. However, congressional investigators say that inspecting the more than 3,000 drug plants in other countries could take more than a decade.

SOURCE: Heparin Recall › Generics may be bio-equivalent of brands, but are they as safe?

At the time the study was stopped, 350 patients had completed a 90 days of follow-up. Twenty-three out of 176 patients who received tinzaparin died, compared to nine out of 174 who received unfractionated heparin. The FDA says it sees no clear pattern as to the cause of death nor do the deaths appear to be related to either over-dosing or under-dosing of an anti-coagulant.

In July, the company revised the prescribing information to restrict the use of Innohep in patients 90 years of age and older. However, preliminary data from IRIS suggests that the increased risk of mortality is not only limited to patients in that age range. Study results suggest that compared to unfractionated heparin, Innohep increases the risk of death for patients 70 years and older with renal insufficiency and deep vein thrombosis (DVT), pulmonary embolism (PE), or both. The FDA suggests health care professionals consider the use of alternative treatments for patients older than 70 years of age with those conditions.

The FDA has requested that the labeling for Innohep be revised to better describe the overall results of IRIS. The agency anticipates final IRIS results in January 2009, and will complete its review at that time.

SOURCE: Heparin Recall › FDA requests better labeling of low molecular weight heparin

Researchers identified the contaminant last April and noted how it could lead to severe allergic reactions. This new MIT report documents the reactions and specifically links them to batches of heparin that were manufactured in Baxter International’s Chinese facility. The findings were published in the New England Journal of Medicine.

In an effort to provide guidance on U.S. quality standards and avoid life-threatening contaminations of drugs imported into the U.S., the FDA has begun setting up foreign offices and placing more than 60 food and drug regulators worldwide. Last month, the agency opened its first foreign offices. Three of those first offices were located in China.

Health and Human Services Secretary Michael Leavitt said the foreign offices will send a clear message to producers that if they want access to the American market, they must make products that meet a higher standard of quality.

SOURCE: Heparin Recall › MIT report proves type of contaminant in Chinese heparin

Baxter International makes heparin, the blood thinner that is routinely used before treatment for kidney dialysis to prevent blood clots as well as during many surgeries. Several lots of heparin manufactured in Baxter International’s China plant were recalled by the FDA earlier this year after they were found to have been contaminated during manufacturing. The tainted heparin ultimately killed more than 80 Americans and sickened hundreds more before an investigation led them to Baxter International’s China plant.

The company also lobbied on bills to improve the safety of drugs imported from foreign countries, and stood up against an effort in Congress to reform the U.S. patent system. According to the story, high-tech companies support that bill, claiming that it would cut down on “frivolous patent-infringement lawsuits.” Baxter International and the pharmaceutical industry argued that doing so would weaken patent protections on drugs by reducing infringement penalties. The bill passed the House but is not expected to pass the Senate this year.

Baxter International also lobbied to give the FDA authority to approve generic versions of biotech drugs, which have never faced generic competition because the FDA does not have the authority to approve the less expensive versions.

SOURCE: Heparin Recall › Baxter International spent thousands on lobbying efforts

Batches of heparin were recalled by the FDA earlier this year after lots manufactured in China were found to have been contaminated with over-sulfated chondroitin sulfate. The investigation and subsequent recall followed reports of more than 80 deaths and thousands more illnesses of patients who had received doses of heparin from the lots in question.

Rep. Joe Barton, R-Texas, last week pointed out that the FDA made conflicting statements to the public and Congress about the number of deaths caused by the blood thinner. Last May, the FDA said it completed a review of three deaths linked to the tainted heparin. Last month, the FDA told Congress that only two deaths were possibly linked to the incident and the third was “unassessable.”

Baxter International, the company involved in the tainted heparin incident, conducted its own investigation and determined that the contaminant was likely not the cause of death in any of the three cases mentioned by the FDA. Baxter’s investigators reviewed patient medical records, interviewed pharmacists and nurses, and visited a hospital where one of the patients had gone before dying.

The FDA came under fire over the tainted heparin scandal after admitting it did not properly inspect Baxter’s China facility. Inspecting all foreign drug manufacturing facilities could take as long as 13 years, the agency has reported. This week the FDA opened its first foreign office, located in Beijing, China, as part of a push to place more than 60 food and drug regulators worldwide to provide guidance on U.S. food and drug quality standards.

SOURCE: Heparin Recall › Lawmaker questions FDA investigation of heparin scandal

This new method is easier and less expensive than analytical methods used previously, such as nuclear magnetic resonance and capillary electrophoresis. Meyerhoff and his team detailed the research in the journal of Analytical Chemistry.

Oversulfated chondroitin sulfate in batches of heparin manufactured in China were responsible for serious allergic reactions that earlier this year killed more than 80 Americans and made thousands more ill.

Heparin was only one of the many products made in China in the past several months was were found to be unsafe for humans and animals. As a result, the FDA vowed to place more than 60 food and drug regulators worldwide over the next year as opposed to sending staffers on individual assignments to inspect foreign facilities. The agency’s first office opened in Beijing Wednesday. Additional Chinese outposts will open in the next few days in Shanghi and Guangzhou.

Earlier this week, HHS Secretary Mike Leavitt and FDA Commissioner Andrew von Eschenbach joined China’s minister of health, Chen Zhu, in a workshop on food safety that focused on policy and government reforms, according to a CNN story about the opening of the Beijing office.

“The government should not just respond to the incident but find the root of it,” CNN quoted Chen in a news conference Wednesday in Beijing.

SOURCE: Heparin Recall › Researchers find new method to detect contaminant in heparin

The move is part of the agency’s effort to place more than 60 food and drug regulators worldwide over the next year. The offices replace the FDA’s previous practice of sending staffers on individual assignments to inspect foreign facilities.

The agency’s Beijing office, which opens Wednesday, will be the first. Thirteen employees will be assigned to work in the China offices.

The AP quoted a statement from the office of U.S. Health and Human Services Secretary Mike Leavitt: “Establishing a permanent FDA presence in China will greatly enhance the speed and effectiveness of our regulatory cooperation and our efforts to protect consumers in both countries.”

The FDA is placing offices worldwide with particular attention to India, Latin America and the Middle East. However, placing offices in China became a priority as a result of numerous reports of contaminated food and drug products manufactured in China. Among the products made in China and recalled by the FDA were batches of the blood thinner heparin, which were found to have been contaminated with over-sulfated chondroitin sulfate (OACA). More than 80 Americans and hundreds more fell ill after receiving the contaminated heparin.

SOURCE: Heparin Recall › FDA opens first foreign office in Beijing this week

During dialysis, patients are hooked up to a machine that draws out the blood through tubing. Since blood tends to clot when it moves through the tubing, patients routinely are given the blood thinner heparin to prevent clotting.

One week before Christmas, after two months of regular dialysis, Bonnie fell ill with diarrhea, vomiting and soon, severe pain in her chest and abdomen. She was rushed to intensive care and within days was unconscious and on a breathing tube. The doctors said there was no more she could do. Leroy’s wife was suddenly and unexpectedly dead.

As Leroy tried to cope with the loss of his longtime wife, their son Randy suddenly became sick with the same symptoms. He was born with the same genetic kidney disease as his mother, and was receiving regular dialysis treatments. His wife, a dialysis nurse, tried desperately to revive him but it was no use. Randy died just three weeks after his mother.

Both Bonnie and Randy were victims of tainted heparin, batches of the drug manufactured in China and later found to have been contaminated with over-sulfated chondroitin sulfate (OSCS). The Hubleys were just two of more than 80 deaths caused by the contaminated heparin. Several hundreds more were sickened by the drug before the FDA recalled batches made in the Baxter International Chinese plant. To date, the FDA has recalled 13 different contaminated medical products containing heparin from various companies.

Last week had U.S. Marshals raided Celsus Laboratories Inc., and found 11 lots of the tainted blood thinner that had not been removed. The recalls and FDA crackdowns come too late for the Hubley family and for the hundreds of families affected by the contaminated heparin. We need to be assured that the contaminated heparin is removed for good so that no more lives are in jeopardy.

SOURCE: Heparin Recall › Time shares story of family affected by heparin contamination

“It’s really horrible for two reasons: one, that a company that knows that their product is not a good product that should be distributed and they’ve been told so,” said Dr. Lynne Wagoner, a Christ Hospital Heart Specialist, who was quoted in the story by WTOL-TV in Toledo, Ohio.

Earlier this month, U.S. Marshals seized a total of 11 lots of the blood thinner at Celsus Laboratories Inc. Heparin was recalled earlier this year after an FDA investigation found that batches of the blood thinner were contaminated with over-sulfated chondroitin sulfate (OACA) at a manufacturing plant in China. The investigation was launched after more than 80 Americans died and hundreds more fell ill after receiving the medication.

The FDA said Celsus Laboratories did not sufficiently carry out the recall process by notifying customers of the contaminant in the heparin it provided. The company distributes both heparin lithium and heparin sodium USP, both of which fell under the recall. As a result, the FDA issued an advisory to manufacturers who may have purchased heparin from Celsus Laboratories to contact the company to make certain they are not using a product from the contaminated batch.

The FDA has recalled 13 different contaminated medical products containing heparin from various companies.

SOURCE: Heparin Recall › Doctors outraged by heparin seizure

The FDA ordered U.S. Marshals to seize the products today. Mike Chappell, acting associate commissioner for regulatory affairs for the FDA is quoted as saying, “This action will help prevent this contaminated heparin from finding its way into the marketplace.”

Earlier this year, heparin manufactured by Baxter International, Inc., was found to be contaminated with OSCS. That heparin also contained components manufactured in China, which is believed to be the source of the contamination. The Baxter contamination led to hundreds of injuries and 81 deaths.

The FDA news release states that the agency has initiated 13 recalls of multiple contaminated medical products containing heparin from several companies, to date this year.

Information in the news release indicates the Celsus heparin entered the United States before the establishment of FDA import controls for the drug, and was reviewed by the FDA after it was processed at Celsus as a part of the agency’s process to implement the controls.

The release also indicates that the FDA knew about the contamination in April 2008, when it warned Celsus Laboratories during an inspection that the company’s actions to notify customers about the contaminant were insufficient. The FDA says it warned Celsus again that it needed to step up its efforts to notify customers about the potential hazard in a May 8, 2008 letter. Finally, today the FDA seized the contaminated product from the lab.

Manufacturers who may have purchased heparin from Celsus are urged to contact the company immediately to make sure they are not using any heparin from the since-seized lots. The product does not meet acceptable quality standards, the release says.

SOURCE: Heparin Recall › Contaminated heparin removed from Cinnicinnati plant

The report revealed that inspecting the more than 3,000 overseas drug plants would take the FDA more than 13 years to complete The agency fired back, saying “The conclusion that FDA should endeavor to conduct foreign inspections based on the same criteria as domestic inspections is…problematic because of the differences in regulatory methodology and resources,” according to the Associated Press.

The need for careful inspections of foreign drug manufacturing plants has come to the forefront since the tainted heparin scare earlier this year that killed more than 80 people and sickened hundreds more. Those batches of heparin were found to have been contaminated in Baxter International’s Chinese manufacturing plant.

Now the Natural News is reporting that the FDA is refusing to release information on which Chinese companies supplied the tainted heparin. According to Natural News, the FDA claims that a confidentially agreements with producers of heparin are preventing the government agency from revealing which Chinese companies supplied heparin ingredients to the United States. It also claims that because of the Memorandum of Agreement that regulates relationships between the FDA and China, the FDA does not have the legal authority to prevent Chinese-manufactured medicines from being imported into the U.S. The FDA says it relies on companies to voluntarily rest their own heparin ingredients, a process that obviously failed last year when contaminated heparin entered the United States.

Meanwhile, Chinese health officials say that it has not been proven that the heparin was contaminated in Chinese plants, and that contamination could just have easily happened in Baxter’s New Jersey plant.

SOURCE: Heparin Recall › FDA will not name Chinese plants that supplied tainted heparin

The U.S. Food and Drug Administration (FDA) recently announced that it will place more than 60 food and drug regulators worldwide over the next year to inspect foreign drug manufacturing plants.

However, congressional investigators say inspecting the more than 3,000 drug plants in other countries could take as long as 13 years, according to the Associated Press. In comparison, U.S. pharmaceutical factories are inspected by the federal government every 2.7 years on average.

Of the 3,249 foreign facilities for which the FDA has set enforcement priorities, the government agency has only been able to inspect an average of 247 per year, compared to 50 percent of the 3,000 U.S. facilities, according to the Government Accountability Office (GAO).

Inspections of most domestic plants involve ongoing surveillance of facilities’ manufacturing practices. By contrast, foreign facilities are inspected before they are allowed to ship drugs to the U.S. When problems are found at a foreign plant, steps are taken to fix them. However, follow up inspections on those measures by the FDA can take up to five years, the report said.

The GAO report stated significant growth in the foreign drug manufacturing market has presented the FDA with “significant challenges” in ensuring the safety of imported drugs, and urged more surveillance of all foreign drug facilities.

SOURCE: Heparin Recall › FDA inspections of foreign drug facilities could take years

The blood thinner heparin made news recently when the FDA recalled batches of heparin after more than 80 people died and several others became ill after receiving heparin. It was later determined that heparin made by Baxter International was contaminated in the company’s Chinese manufacturing facility.

While heparin is considered an effective treatment for preventing blood clots and is widely used, it must be injected, which makes long-term therapy difficult. The new drugs would be taken by mouth, which would make dosing easier and eliminate the need for laboratory monitoring.

Heparins garner about $700 million in annual sales, with Sanofi-Aventis’ Lovenox making up nearly two-thirds of the world’s share of the drug. Pfizer’s Fragmin and GlaxoSmithKline’s Fraxiparine account for 6.3 and 5.9 of sales, respectively. Vitamin K Antagonists are responsible for more than $6 billion in sales worldwide, with Bristol-Myers Squibb’s Coumadin, Barr’s Warfarin and Eisai’s Warfarin owning slightly more than half the market’s share.

Three of the five companies are in the late phases of clinical testing, two of which already have been approved in Canada and are awaiting approval in the United States. Two other companies’ drugs have been approved for short-term use in Europe.

SOURCE: Heparin Recall › Pharmaceutical companies developing drugs to fight blood clots

“We are sending a very clear message to producers: if you want to have access to our market you need to make products that meet our standards of quality,” Health and Human Services Secretary Michael Leavitt was quoted in the story. Leavitt oversees the FDA and other federal health agencies.

While particular attention will be paid to India, Latin America and the Middle East, the FDA will make China a priority, establishing its first office in Beijing by the end of the year. The Beijing office will employ eight U.S. staffers. Additional outposts are planned for Shanghai and Guangzhou.

Products made in China have caused much heartache lately. Last spring, the FDA
recalled batches of heparin after some lots were found to have been contaminated while produced in Baxter International’s Chinese factory. The tainted heparin killed more than 80 people and sickened hundreds more.

Similarly, dozens more products made in China have been recalled over the past several months for harming people, including tainted baby formula, toys made with lead-based paint, and contaminated pet food.

Details on how the FDA will carry out the plan are unclear, as FDA officials admit that the hiring of several dozen more staffers, as the plan lays out, would not provide enough personnel to visit the thousands of plants around the world.

SOURCE: Heparin Recall › FDA to set up offices worldwide

FDA approval isn’t a guarantee of safety. For example, last spring, FDA-approved batches of heparin were recalled after they were found to have been contaminated. The tainted drug killed more than 80 people and sickened hundreds more before the FDA recalled the medication.

At issue in the new Supreme Court term is the “final rule” established on June 30, 2006, by the FDA. That rule protects drug companies whose drugs have harmed others from lawsuits by individuals who have been harmed. This extends to companies that deliberately withheld information that would have proven their drug to be harmful.

According to the Natural News story, the FDA runs without oversight and has declared that it gets the final word on a drug’s safety regardless of its harmful effects. Therefore, both the FDA and the pharmaceutical companies it represents are protected from suits under this arbitrary rule.

The Supreme Court currently is considering a lawsuit against drug-maker Wyeth and its drug Phenergan after a woman who received an injection of the nausea drug led to a gangrene infection that resulted in the amputation of her arm. Wyeth is accused of inadequately warning about the risks involved with this type of injection.

SOURCE: Heparin Recall › High court rule may affect right to sue drug makers

“With more drug companies buying ingredients and producing products overseas, country-of-origin labeling is more important than ever,” Sen. Brown said in a press release.

Country-of-origin labeling for active pharmaceutical ingredients was initially proposed last April as part of the Food and Drug Administration (FDA) Globalization Act. Sen. Brown’s proposal would require similar labeling for active ingredients as well as inactive ingredients on both prescription and over-the-counter medications.

The bill comes on the heels of the FDA recall of heparin last spring, which was found to have been contaminated at Baxter International’s China manufacturing plant. The contaminated heparin killed more than 80 people and sickened hundreds more.

The bill coincides with new provisions for country-of-origin labeling of food products. As of September 30, 2008, retailers must notify their customers of the country of origin of commodities outlined by the newly amended Agricultural Marketing Act of 1946.

With so many alarming recalls from China – from contaminated heparin and baby formula to toys laced with lead paint and generators plagued by fire hazard claims – knowing where our medications and food originate will help us all make more informed decisions whether to buy them.

SOURCE: Heparin Recall › Senator proposes country-of-origin labeling for medications

Nearly 100 pharmacists and the hospitals they work for were fined $2,000 to $5,000 by the Board of Pharmacy, according to the report.

The Food and Drug Administration (FDA) recalled heparin early last year after a large number of patients suffered adverse effects after taking the drug. The FDA later determined that batches of heparin made in China contained a contaminant that ultimately killed more than 80 people and made hundreds more ill.

In 2004, California took the lead in making sure recalled medicines were removed from pharmacy and hospital shelves by becoming the only state in the country to approve a stringent electronic system for drug makers, wholesalers and pharmacies to track all prescription drugs from manufacturer to patient, according to the San Francisco Chronicle.

But implementing this system has been challenging. The law originally was set to go into effect in 2007, but was delayed until January 1, 2009. Last March, the California Board of Pharmacy voted to give until Jan. 2011 to start electronic tracking. Board officials were concerned if they did not extend the deadline that the law would be poorly implemented or drug makers would refuse to sell their medications in California.

SOURCE: Heparin Recall › Recalled heparin still appearing in hospitals, pharmacies

Last month I told you that California Rep. Harry Waxman, who serves as head of the House Oversight and Government Reform Committee, raised concerns that items outlined on the FDA’s 2007 priorities list appeared to prioritize industry desires over consumer protection.

This, just months after more than 80 American deaths were linked to tainted heparin that was made in Baxter International Inc.’s facility in China. FDA officials later acknowledged they had not inspected that facility and claimed they had insufficient staff and financial resources to regularly inspect overseas manufacturers.

Today, the Washington Post reported that the FDA has hired a public relations company it improve its image. However, in yet another PR blunder, the story reports that the way it hired the company may also be raising eyebrows.

The story suggests that the FDA may have violated government contracting rules by not holding a bidding competition for a $300,000 contract hiring a firm to create “a lasting positive public image for the agency.” Instead it made a deal with Alaska Newspapers Inc., (ANI) which is exempt from having to compete for federal work because it qualifies for special set-asides. ANI agreed to funnel all the work to the FDA’s agency of choice, Qorvis Communications. Apparently the FDA’s new PR head, Mildred Cooper, had connections to the firm and wanted to use it.

The FDA cancelled its contract with ANI/Qorvis Communications after the Washington Post’s story ran. And while the FDA claims it never meant to do anything questionable during the selection process, this latest blunder certainly hasn’t helped the organization’s public image.

SOURCE: Heparin Recall › FDA makes blunder during hiring of PR firm to improve image

Alchemia’s CEO, Dr Peter Smith said “The impending commercialization of generic fondaparinux and anticipated revenues in calendar year 2009 will form a strong financial base for Alchemia. This will enable the company to advance its drug targeting and drug discovery technologies to further build a sustainable pipeline of opportunities for future commercialization.”

The company’s report states: “Given the complexity of the synthesis, Alchemia continues to believe that its generic fondaparinux will be the only generic brought to market, restricting competition to two drugs, Alchemia’s fondaparinux and GSK’s Arixtra. Typically, a first generic will take 40-50 percent of the prescription share, and with Alchemia’s fondaparinux expected to be the sole generic, a modest level of price discounting is anticipated.”

Arixtra is the only heparin drug not derived from biological sources as it is a synthetic molecule. Thus, it was not among the recent heparin recall.

Alchemia contends that there are no significant technical hurdles remaining and that generic fondaparinux approval and launch is expected in the first half of 2009, depending on review time at the FDA.

SOURCE: Heparin Recall › Synthetic heparin expected to launch early 2009

Lovenox, the company’s number one selling medicine, was first recalled last June after some batches of its pre-filled injectible solution were found to be contaminated with trace amounts of oversulphated chondroitin sulphate, according to Reuters.

Oversulphated chondroitin sulphate is the same contaminate found last March by the Food and Drug Administration (FDA) in batches of heparin that killed more than 80 Americans and sickened hundreds more. Those batches were traced back to Baxter International’s Chinese plant.

The level of contaminant found in Lovenox was much lower than what was found in the heparin manufactured by Baxter International, according to Forbes.

So, what exactly is oversulphated chondroitin sulphate?

According to a March 20, 2008, New York Times report, chondroitin sulphate is an inexpensive and readily available dietary supplement made from animal cartilage. In its natural state chondroitin sulphate does not have anticlotting properties, however when it is altered to what is called oversulphated chondroitin sulphate, it mimics heparin.

According to the FDA, oversulphated chondroitin sulphate is not an approved drug in the U.S., nor should it be found in heparin, as it likely caused the allergic reactions that have killed and sickened so many individuals worldwide.

SOURCE: Heparin Recall › French Lovenox brand heparin recall

According to the report, aides for both candidates said that recent health scares had dampened their candidates’ enthusiasm of reimportation. Neither candidate has abandoned the prospect; however, they admit it has become a more controversial subject.

Other countries, such as Canada, have government price controls that keep prescription drug costs down, making reimportation of foreign drugs a far more attractive option, especially for those who spend hundreds and thousands of dollars on prescriptions each year. While several U.S. bills on reimportation have been proposed, none have become law, the report stated.

Organizations representing pharmaceutical companies such as the Generic Pharmaceutical Association (GPhA), oppose the practice, arguing that there is no guarantee drugs or goods from other countries would be safe, Reuters/Boston Globe reported.

Earlier this year, American deaths were linked to tainted heparin that was made in Baxter International Inc.’s facility in China. According to news report, FDA officials acknowledged they had not inspected that facility and claimed they had insufficient staff and financial resources to regularly inspect overseas manufacturers.

SOURCE: Heparin Recall › Candidates review reimportation of prescription drugs

The FDA also planned to change its regulations to protect device makers’ FDA-approved products from lawsuits with a so-called preemptive clause, according to Reuters.

The news agency says that in a letter from California Rep. Henry Waxman, to FDA Commissioner Andrew von Eschenbach, Waxman raised concerns that the items outlined on the FDA’s 2007 priorities list “all appear to prioritize industry desires over consumer protection.”

Then-FDA Chief Counsel Sheldon Bradshaw told Waxman in an e-mail that he planned to forward the list of priorities to Deputy Secretary of Health and Human Services Tevi Troy. Both Bradshaw and Troy have ties to the pharmaceutical industry, Reuters reports.

Waxman, who serves as the head of the U.S. House of Representatives Oversight and Government Reform Committee, suggested that political appointees at the agency may be promoting industry priorities at the expense of FDA’s core public health mission.

Highly publicized safety scares, including bacteria-laced foods and contaminated batches of heparin, have put the FDA in the hot seat in recent years. According to Reuters, an FDA spokesperson said the agency would respond directly to Waxman about the concerns he raised.

SOURCE: Heparin Recall › Lawmaker questions FDA priorities, suggests industry ties

According to information on its web site, Fresenius, based in Hamburg, Germany, is the world’s largest integrated provider of products and services for individuals undergoing dialysis because of chronic kidney failure. It estimates more than 1.6 million people are affected by kidney failure worldwide.

The AP says the purchase of APP Pharmaceuticals will help Fresenius lower its expenses. Heparin is used by patients on kidney dialysis.

U.S. regulators approved the purchase, which is expected to close by mid-September, according to the AP report. As a result of the sale, APP Pharmaceutical shares rose 13 cents to $23.80, the AP reports.

SOURCE: Heparin Recall › Fresenius buys heparin maker APP

According to a report in the Pharmaceutical Business Review, APP currently manufactures nine products at its Puerto Rico facility, including doxycycline, azithromycin and diphenhydramine. The report says the company plans to manufacture more than 19 million units in Puerto Rico during 2008 and to eventually transfer more than 25 additional product codes to the facility.

The recall of contaminated heparin manufactured in China has affected the availability of the product, which is a blood thinner used in surgical procedures.

Baxter International, Inc., recalled all remaining lots and doses of its sodium injection multi-dose, single-dose vials and HEP-LOCK heparin flush products, both preserved and preservative-free, in February, and suspended production of the products. Prior to the recall, Baxter manufactured about half the multidose vials used each month by health care providers.

APP expects the transfer of its additional product codes to the Puerto Rico facility will translate to approximately 50 million units annually. APP currently has manufacturing facilities in Illinois and New York.

Pharmaceutical Business Review quotes Tom Silberg, CEO of APP Pharmaceuticals, as saying, “Bringing this third manufacturing site on-line is an important part of our commitment to ensuring that an uninterrupted and safe supply of heparin of the highest quality is available for US patients.”

Founded in 1996, APP Pharmaceuticals is a leading manufacturer of multi-source and branded injectable pharmaceutical products for acute medical care both in patient and ambulatory settings.

SOURCE: Heparin Recall › APP ok to make heparin in Puerto Rico

Journal editor Dr. Jeffrey M. Drazen says the litigation process and the court system is a “key defense mechanism” to insure drug safety and to obtain justice if drug manufacturers have not made the risks involved with its product clear.

The doctors say the FDA is incapable of being the sole guardian of drug safety and that without the information supplied by liability litigation, “the American public would be deprived of a vital deterrent against pharmaceutical company misconduct.”

The opinion was submitted to the Supreme Court as a friend-of-the-court brief in the matter of Wyeth v. Levine, a case expected to be heard later this year. According to the AP story, the case involves Diana Levine, a guitarist who lost her right arm below the elbow after an injection of Phenergan. She sued the drug’s manufacturer, Wyeth, alleging the company had not adequately warned consumers of the risks associated with its product. The case was tried in Vermont, and the court agreed, awarding Levine $7 million.

Wyeth is appealing the case, saying the FDA had approved the drug, and that the state court could not overrule the FDA’s judgment.

However, the editors of the New England Journal of Medicine sided with 47 state attorneys general and two former FDA commissioners in supporting Levine’s position, the AP report states.

SOURCE: Heparin Recall › doctors favor drug safety litigation

The new expanded recall includes all remaining lots and doses of Baxter’s heparin sodium injection multi-dose, single-dose vials and HEP-LOCK heparin flush products, both preserved and preservative-free. The recall will not include Baxter’s heparin pre-mix IV solutions in bags.

Although there was a danger of contamination that could result in adverse patient reaction, the U.S. Food & Drug Administration did not require Baxter to do a full recall of the product in January because pulling all of the product could create a shortage for operating rooms, dialysis centers and other critical areas that use the product, which is a blood thinner.

According to a Baxter news release, in January the FDA determined the risk of patients not receiving any heparin blood thinners when it was critically needed was greater than that of patients receiving contaminated product. Baxter is one of the leading suppliers of heparin products, manufacturing about one half of the multidose vials used each month by health care providers.

The FDA now feels there is enough heparin available from other sources to allow Baxter to pull its remaining, possibly contaminated, product.

Customers are advised to immediately discontinue use of recalled product, and to contact Baxter for return and replacement.

Despite FDA assurances that there is enough heparin product in the market to treat critical patient needs, by March health care providers were being more careful with prescribing their existing supplies as a result of the more limited supply.

SOURCE: Heparin Recall › Baxter expands heparin recall

The U.S. Food and Drug Administration announced today that Baxter Healthcare Corporation has temporarily stopped manufacturing multiple-dose vials of the injectable blood-thinning drug heparin due to reports of serious allergic reactions and hypotension (low blood pressure) in patients who receive high “bolus” doses of the drug.

Serious reactions to the drug have included difficulty breathing, nausea, vomiting, excessive sweating, and rapidly falling blood pressure that can lead to life-threatening shock. Four people have died after receiving heparin, although the relationship to the drug is unclear.

Heparin sodium is derived from pig intestines and has been marketed in the United States since the 1930s. Millions of patients benefit from the intravenous administration of this drug every year to avoid potentially life-threatening blood clots in the veins, arteries, and lungs.

“FDA concurs with Baxter’s decision to halt manufacture of heparin sodium in multiple-dose vials,” said Janet Woodcock, M.D., FDA’s deputy commissioner for scientific and medical programs, chief medical officer, and acting director of its Center for Drug Evaluation and Research. “FDA is vigorously investigating to determine the root cause of these serious reactions associated with the use of heparin made by Baxter. In the meantime, patients and health care professionals who cannot obtain alternative sources of heparin should use caution in administering any Baxter multiple-dose vials that remain.”

Heparin is commonly used before certain types of surgery, including coronary artery bypass graft surgery, and in kidney patients before they undergo dialysis. In some situations, heparin treatment is initiated using a high bolus dose given directly into the bloodstream (intravenously) over a short period of time, usually less than one hour. The reported adverse events occurred in patients who were given heparin in this form of administration. There are many other uses of heparin involving lower doses or administration over a longer period of time; adverse events have not been seen with those uses.

About 350 adverse events associated with the Baxter product have been reported since the end of last year compared to less than 100 reports in 2007. Most of the events have taken place at hemodialysis centers, almost exclusively involving patients receiving a bolus dose – which is a high dose administered over a short time. While most of the reports involve multiple-dose vials, several cases include patients who received a bolus dose after their health care professional combined heparin from single-dose vials.

The Missouri Department of Health and Senior Services first notified the Centers for Disease Control and Prevention (CDC) in January of several severe allergic-type reactions to heparin that occurred at a single pediatric hospital beginning in November. The CDC in turn alerted FDA and Baxter, prompting the company’s voluntary recall of nine lots of heparin on Jan. 17.

Since then, FDA has learned of adverse events that extend beyond the recalled lots and involve patients receiving heparin for other purposes besides hemodialysis. Recent cases have included patients undergoing cardiac surgery and a specialized blood cell treatment known as photopheresis.

Over one million multiple-dose vials of heparin are sold per month in the United States; half of the vials are manufactured by Baxter of Deerfield, Ill. FDA is currently investigating whether similar events have been seen with other heparin manufacturers.

Physicians, dialysis center staff and health care providers are advised to use an alternate source of heparin or another blood-thinning drug when possible. When only Baxter product is available:

• Administer the heparin as an infusion (not a bolus) whenever possible.
• Use the lowest dose necessary at the slowest infusion rate acceptable to obtain the desired clinical effect.
• Closely monitor the patient for adverse events, particularly hypotension and signs and symptoms of hypersensitivity and ensure that resuscitation equipment is available.
• Consider pretreatment with corticosteroids (cortisone type medicines) or antihistamines (drugs that relieve the symptoms of allergic reactions) although it is not known if such pretreatment is effective.

Any allergic-type reaction to heparin infusion should be reported to FDA’s MedWatch Program by phone at 800-FDA-1088, by fax at 800-FDA-0178, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, M.D. 20852-9787, or on the MedWatch Web site at www.fda.gov/medwatch.

SOURCE: http://www.fda.gov/bbs/topics/NEWS/2008/NEW01797.html

SOURCE: Heparin Recall › Heparin Linked to Severe Allergic Reactions