Heparin is a widely used blood thinner used to treat and prevent blood clots. In March 2008, major recalls of heparin were announced due to severe adverse reactions and deaths from lots manufactured in a China facility that a Food and Drug Administration (FDA) investigation revealed were contaminated with OSCS. The FDA later admitted that it was lax in its responsibilities to inspect overseas drug plants before approval drugs for sale.

Though no adverse reactions have been reported to B. Braun and the manufacturer does not believe the drugs pose a significant health risk, customers who have the recalled lots heparin in their possession are urged to discontinue use immediately. B. Braun is also arranging for return of all recalled products. Customers can direct questions to B. Braun at 800-227-2863.

Patients who are or have been using this product and have experienced any problems should contact their physicians. Any side effects should be reported to the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch.

SOURCE: Heparin Recall › Tainted lots of heparin recalled

The complaints accuse Baxter and its supplier, Scientific Protein Laboratories LLC, of negligence, alleging Baxter’s heparin was unsafe for the intended use. The lawsuits seek money damages.

The nightmare began in late 2007, as reports of serious allergic reactions and deaths following use of Baxter’s heparin began mounting. By March 2008, the Food and Drug Administration (FDA) issued a major recall of heparin. At the time, Baxter supplied about 50 percent of heparin to the U.S. As Baxter began pulling its heparin, investigations into the source of the contaminant focused on Baxter International’s China plant. The culprit was identified as over-sulfated chondroitin sulfate, or OSCS, a man-made chemical that mimics heparin.

While Baxter was at fault for distributing the tainted heparin, critical eyes fell on the FDA for not properly inspecting foreign drug manufacturing plants. The agency admitted it was simply too understaffed to properly inspect most of the foreign food and drug manufacturing plants. The FDA soon after received funding to open overseas field offices, the first three of which were opened in China.

The stricter inspections hardly console the victims and families of victims who suffered or died from the contaminated blood thinner. The FDA reports that as many as 395 deaths and 785 reports of serious injury were associated with the contaminated heparin.

Source: Bloomberg

SOURCE: Heparin Recall › Baxter faces numerous lawsuits over tainted heparin scandal

The alert was issued to pharmacists, physicians, hospital risk managers and consumers, and advised those parties to be aware that the change may have clinical significance in some situations. Because of the decrease in potency, health care providers should monitor the anticoagulant effect of the drug in patients as more heparin may be needed to achieve and maintain the desired level of anticoagulation in some patients.

The FDA is working with the new manufacturers of heparin to ensure that an appropriate identifier is placed on heparin made under the new USP monograph. Most manufacturers will place an “N” next to the lot number. The agency also is working with heparin manufacturers to study the impact of this variation in potency, and will make the results of the study available soon.

Consumers should be aware that their doctor may prescribe a higher dose of heparin that normally received, or patients may receive more monitoring after receiving doses of heparin than previously.

The changes will start affecting the heparin used in the healthcare settings on or after October 8, 2009. Patients should contact their healthcare provider if they have any questions or concerns about their heparin treatment.

SOURCE: Heparin Recall › FDA notifies public about changes to heparin potency

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

Named in the lawsuit are Baxter International, Baxter Healthcare Corporation and Scientific Protein Laboratories. Both Baxter International and Baxter Healthcare have been sued 24 times in 2009 alleging the drug maker’s heparin was contaminated and led to death or serious injury.

In February 2008, the Food and Drug Administration (FDA) ordered a recall of nine lots of Baxter’s heparin manufactured in the company’s China plant after more than 80 deaths and hundreds of illnesses were reported following the use of the drug. The FDA later found the heparin had been contaminated with over-sulfated chondroitin sulfate (OSCS). OSCS mimics heparin but can cause serious allergic reactions and even death in individuals who take receive it.

The recall included all lots and doses of heparin sodium injection multi-dose, single-dose vials and HEP-LOCK heparin flush products, both preserved and preservative-free. Baxter also suspended production beginning in early February 2008.

Baxter is one of the leading suppliers of heparin products, manufacturing about one half of the multi-dose vials used each month by health care providers.

Source: Chicago Bar-Tender

SOURCE: Heparin Recall › Four lawsuits filed in contaminated heparin case

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

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

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

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

Ralph Sell of Lincoln, Nebraska, says that his wife Alice was undergoing cancer treatments in December 2007 when a syringe contaminated with Serratia marcescens, a bacteria that can cause serious injury or death, was used on her. She suffered high blood pressure, disorientation and sepsis. She died a year later at the age of 82 of “acute respiratory failure.” It has not yet been determined if the contaminated syringe may have led to her death.

Sell filed suit against Baxter International as well as its subsidiary Baxter Healthcare Corp., B. Braun Medical Inc., and AM2 PAT Inc, also known as Sierra Prefilled. A spokesperson for Baxter says the company has no role in the lawsuit, as it does not sell prefilled saline syringes. AM2 PAT did recall saline prefilled syringes in December 2007 and January 2008 because some of the syringes were tainted with the bacteria.

Baxter currently faces numerous lawsuits stemming from a 2008 recall of the blood thinner heparin. Batches of the company’s heparin manufactured in China were found to have been contaminated with over-sulfated chondroitin sulfate (OSCS). The tainted heparin is believed to have contributed to the deaths of more than 80 Americans and caused serious illnesses in hundreds more.

Sell’s lawsuit against the companies seeks unspecified damages and payment for medical costs.

SOURCE: Heparin Recall › Baxter named in contaminated saline syringe lawsuit

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

American Capital purchased 87 percent of Scientific Protein Laboratories in 2006. Scientific Protein Laboratories has a fair market value of $186.5 million. Last year, the parent company sought coverage from its insurers for lawsuits related to Scientific Protein Laboratories’ involvement in the tainted heparin scandal.

While Baxter International is at the center of the tainted heparin controversy, the Charter Oak Fire Insurance Co. and Travelers Property Casualty Co. of America argue that in its application for coverage, Scientific Protein Laboratories’ parent company American Capital claimed it had no subsidiaries and never mentioned Scientific Protein Laboratories or its China-based heparin venture, according to the report. In its lawsuit filed last week, the insurance companies claim that “American Capital provided false answers to Charter Oak and Travelers regarding the non-existence of subsidiaries.”

The lawsuit also claims that American Capital and Scientific Protein Laboratories entered into an agreement with Baxter International that included making payments to Baxter and giving “rights to insurance proceeds and benefits,” according to the report.

SOURCE: Heparin Recall › Heparin producer’s insurers file lawsuit

Heparin is a blood thinner used to prevent blood clots. It is often given before surgery and during treatments such as kidney dialysis to prevent clotting. In appropriate use or overdosing can be fatal.

This week, Zelenka – known to some as the “heparin murderer” – was sentenced to life for the murder of seven people, according to Czech media outlet Noviny. Police have pinned another three murders on him as well as one attempted murder.

Police are looking into 14 other cases in which they suspect murder or attempted murder. Another ten cases were closed after police couldn’t find proof that a crime was committed. Even if authorities link more murders and attempted murders to Zelenka, he will not be prosecuted as he currently will serve the highest sentence for the crimes he already has been found guilty of.

Zelenka admitted to all crimes but during the trial said he only remembers administering heparin to five patients. He says police coerced him into admitting to additional crimes.

SOURCE: Heparin Recall › Czech ‘heparin murderer’ gets life in prison

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 security guards called police, who searched her vehicle and discovered three bags containing dozens of medications, including painkillers, anti-anxiety drugs, anti-seizure drugs, nicotine patches, and the blood thinner heparin.

Lopez, who had been led back to the hospital while they waited for police to arrived, had locked herself in the bathroom. When police were finally able to enter the bathroom, Lopez was visibly nervous with “pinpoint pupils,” according to the story. Police had no explanation for what Lopez intended to do with the array of medications.

According to the report, Lopez was charged with receiving stolen property worth more than $250 and with possessing controlled substances. She pleaded not guilty and was released on $500 bond. Depending on the outcome of an investigation, Lopez could face disciplinary action such has suspension or license revocation.

SOURCE: Heparin Recall › Pharmacy tech steals bagfuls of heparin and other drugs

Moving from a paper system to an electronic medical records system was designed to reduce human error; however, health care experts say the errors prove that the VA’s system still needs to be carefully monitored. There have been no reports of harm caused by the errors, but the situation remains under review.

The errors involved medical data such as lab results, medications and vital signs that would show up under the wrong patient’s name. Doctor’s orders also were not clearly displayed, often resulting in unnecessary administering of intravenous drugs such as heparin.

VA released a statement saying that nine patients at the VA hospitals in Milwaukee, Durham, N.C., and Marion, Ind., were given incorrect doses, six of which involved heparin that was given for up to 11 hours longer than necessary, according to the Associated Press report. Other cases included infusions of sodium chloride or dextrose mixtures that were given up to 15 hours longer than prescribed.

Veterans with questions or concerns can request a copy of their medical records at www.myhealth.va.gov.

SOURCE: Heparin Recall › AP: ‘software glitches’ led to prolonged infusions of heparin

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

Most often occurring in women, IC is often mistaken for chronic prostatitis or chronic pelvic pain syndrome. The cause is largely unknown, however some factors may be connected to the disease, such as bladder trauma, bladder over distention, pelvic floor muscle dysfunction, autoimmune disorder, bacterial infection and spinal cord trauma. The disease is subcategorized as non-ulcerative IC, by far the most common form, and ulcerative IC.

In the treatment of IC, heparin mimics the activity of the bladder’s mucous lining, which may be defective in those with IC. According to clinical studies, some improvement was found in about half of the patients who were on a heparin treatment plan. The heparin treatment may be given by injection or bladder instillation, however bladder instillation is the recommended delivery for patients with IC. The treatment of bladder instillation of heparin begins as daily routine and is reduced to three to four times a week after three to four months. Self-catheterization can be taught to patients who want to administer the treatment at home.

SOURCE: Heparin Recall › Heparin a treatment option for Interstitial Cystitis

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

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

Researchers at Beaumont Hospital in Royal Oak, Michigan, have developed a treatment protocol to quickly and effectively diagnose brain bleeds in patients who are on blood thinners and bump their heads. The study treated 105 patients under the new protocol. As a result, diagnosis of brain bleeds occurred in half the time and treatments were started faster. Under this new system, death rate also was reduced from 40 percent to 11 percent.

The protocol includes rapid initial evaluation by a doctor or nurse, a CT scan performed on a priority basis, a blood transfusion and administration of vitamin K to help the blood clot, according to the report.

“These seem like relatively simple steps, but when combined they become a powerful force that helps save lives,” Emax Health quoted Greg Howells, M.D., director of Trauma Surgery. When the head bumps occur, many people can appear fine even if the injury is causing the brain to bleed. Previous studies have shown that people on blood thinners are four times more likely to die from a blow to the head than those not on blood thinners.

As a result of the study, more than 40 other hospitals across the country have asked about Beaumont’s treatment protocol for people on blood thinners who bump their heads.

SOURCE: Heparin Recall › Head injury protocol reduces death rate for patients on blood thinners

The findings come from research published this week in the Journal of the American Medical Association and funded by the National Institutes of Health and University of Chicago. The study is based on interviews of 3,000 people aged 57 to 85. The research shows that more than half of the older population is taking at least five different medications including prescriptions and over-the-counter drugs or supplements. Men are particularly at risk, according to the report. As many as one in 10 older men were taking drug combinations that could be harmful.

One alarming drug combination occurs when a patient is on a blood thinner. Combined with common over-the-counter medicines such as NSAIDS like ibuprofen, naproxen or aspirin, this can lead to excessive and uncontrolled bleeding. Cigarette smoking also decreases blood levels.

Heparin, one of the more common blood thinners administered intravenously at hospitals before some surgeries and treatments such as kidney dialysis to prevent blood clots, carries the same warnings. Patients – whether at home or in the hospital – should be forthcoming about all medications – prescription and over-the-counter – and supplements they are taking to avoid any potential risk.

Patients also should not take new over-the-counter medication or supplements or stop taking a medication without first checking with their doctors.

SOURCE: Heparin Recall › Older Americans may be taking hazardous drug combinations

Blood thinners are routinely given to patients before certain types of surgery and 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 a stroke, or in the lungs, causing a pulmonary embolism. Blood clots, also known as thrombosis, is a serious problem affecting nearly a million Americans each year and killing nearly 300,000 annually.

Two more common types of blood thinners are heparin and warfarin. Heparin is administered intravenously, requiring medical supervision, whereas warfarin is given orally. Both drugs have been used medically for decades. Both have side effects that doctors and patients find bothersome, including easy bruising, excessive bleeding, lower back pain, weakness or light-headedness, and flu-like symptoms. Thus physicians are eager to find safer alternatives.

Furthermore, heparin has been in the spotlight continuously over the past several months for confusing labeling that has resulted from overdoses that have sickened and killed patients, as well as batches of contaminated heparin that made its way into hospitals, causing more illnesses and deaths in patients who received the bad lots.

SOURCE: Heparin Recall › Drug makers rush to produce new blood thinners

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

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

Thromboembolism is a blood clot in the blood vessel that breaks loose and is carried by the blood stream to plug another vessel. The clot may plug a vessel in the lungs, causing pulmonary embolism; brain, causing a stroke; gastrointestinal track, kidneys or leg. Thromboembolism is a common complication of cancer and cancer treatments, and is usually treated with blood thinners, such as heparin.

Though a relatively new therapy for the prevention of thromboembolism, low-molecular-weight heparins, such as nadroparin, are as effective as high-molecular-weight heparins. One benefit to low-molecular-weight heparins is that treatment can be started and completed in an outpatient setting, as opposed to high-molecular-weight treatments, which require in-hospital monitoring.

The study involved 1,166 patients with metastatic cancer receiving chemotherapy for cancers involving the lungs, breasts, head and neck, stomach, colon, rectum and pancreas. The incidence of blood clots in patients who received nadroparin was 2.1 percent compared to 3.9 in patients who received a placebo. Higher rates of thrombembolism was present in patients with lung and pancreatic caners. The study also showed a slight (0.7 percent) incidence of major bleeding in patients who received nadroparin compared to 0 percent in the placebo group.

SOURCE: Heparin Recall › Low-molecular-weight heparin good therapy for cancer patients

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

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?

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

“Previously it was nearly impossible to change the nature of the heparin generated by the enzyme,” said Jian Liu, Ph.D., associate professor at the UNC Eshelman School of Pharmacy medicinal chemistry and natural products division. “The degree of difficulty was 10-plus. Now it’s more like a two or three, which opens the door to the possibility of improving on the natural product.”

The method involves modifying the enzyme heparan sulfate 2-O-sulfotransferase, which produces heparin in the human body in addition to other heparin-like molecules. By modifying 2-O-sulfotransferase, researchers will be able to create customized forms of synthetic heparin with different properties, according to the report.

Heparin is typically administered to most patients during surgery and before some treatments such as kidney dialysis to prevent blood clots from forming. Heparin is produced naturally by most animals, including humans, but most heparin available today is derived from pig intestines. China has become a popular location for manufacturing heparin because it has a much larger pig population.

However, heparin manufactured in China raised concerns earlier this year after batches from Baxter International’s China plant were found to have been contaminated. The investigation into heparin resulted after more than 80 Americans died and hundreds more were sickened after receiving doses of the tainted heparin. As a result, researchers have been working to find safer alternatives to heparin, including developing synthetic versions.

“The pig stuff has served us well for 50 years and is very inexpensive, but if we cannot control the supply chain, we cannot ensure the safety of the drug,” Liu said. “I am working for the day when synthetic heparin can be brewed in large laboratories at a low cost.”

Liu and her colleagues also are looking into customizing heparin for other uses, such as a treatment for small-cell lung cancer.

Liu’s research recently was published online in the journal Proceedings of the National Academy of Sciences.

SOURCE: Heparin Recall › Scientists on road to modifying, customizing human heparin

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

Dr. Deborah Cook, academic chair of critical care medicine at St. Joseph’s, is leading a study to determine whether the newer and more expensive version of the blood thinner is more effective for patients in intensive care than the older one. Fifty-six ICUs in Canada, Australia, Brazil, U.S. and Saudi Arabia will participate in the study. Patients will be chosen at random from each of the participating ICUs.

The study also will look at each drug’s side effects, which can include excessive or unusual bleeding.

Heparin, which is used to prevent blood clotting, is routinely given to most ICU patients. The newer version has been touted as being stronger and thus is used most often. The newer heparin costs about $9 per day per patient compared to $2 per day per patient for the older version.

The study, which is called PROTECT and stands for Profhylaxis of Thromboembolism in Critical Care Trial, is funded by the Canadian Institutes of Health Research. No results have yet been posted for the study, which is currently halfway through the 2 ½-year research process.

SOURCE: Heparin Recall › Study compares brands of heparin given to ICU patients

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

Heparin is a blood thinner that is routinely used before certain types of surgery or other procedures to prevent clotting. It also is widely used for patients with chronic thrombotic conditions. Heparin is administered intravenously, which requires constant monitoring of doses and in-patient hospital stays. An oral alternative could reduce the need for expensive hospital stays.

About 2 million Americans each year suffer from thrombotic conditions and another 200,000 die each year from stroke, myocardial infarctions or pulmonary emboli as a result of thrombosis, according to the report.

The heparin will use glycosaminoglycan (GAG) technology to develop the oral alternative.

“The introduction of an oral heparin into clinical medicine would be a significant development and would have commercial, therapeutic and economic potential. We are pleased that Glycotek will take on this important challenge while at HCAR,” said Laura Butcher, Executive Director of HCAR, in the Business Wire report.

Glycotek will pursue both business and research and development activities at HCAR. Building upon its activities already in practice at its New York location. HCAR provides state-of-the-art facilities and high-value business and research resources.

SOURCE: Heparin Recall › Glycotek developing oral alternative to heparin

Heparin is routinely used before certain types of surgery or other procedures are preformed to prevent clotting. Afterward, doctors will often remove the blood thinner to avoid unwanted bleeding by using the medication protamine.

Protamine is a weak anticoagulant drug that is administered intravenously and acts as a heparin antagonist. But protamine carries a risk of serious side effects such as difficulty breathing; swelling of the mouth, face, lips or tongue; wheezing; muscle pain; confusion; fainting; fast or irregular heartbeat; mood changes; seizures; slurred speech; headache; loss of consciousness; unusual hunger; unusual sweating; and weakness.

Many people also experience allergic reactions from heparin, including organ failure, heart problems and shock. Batches of the drug also have been recalled or seized by the federal government after more than 80 people died and hundreds more were sickened by heparin that was found to have been contaminated during manufacturing.

In an effort to find a safer product to remove heparin from the bloodstream, Krzysztof Szczubialka and his team of researchers have developed a new product made of microscopic polymer beads from modified chitosan, a product of shellfish. Lab tests show that the new material reduced heparin concentrations to nearly zero within 10 minutes. The product will be detailed in the December issue of American Chemical Society’s monthly journal, Biomacromolecules.

SOURCE: Heparin Recall › Scientists develop heparin antagonist medication

Septic shock is a serious condition that can cause multiple organ failure and death. It is the main cause of mortality in intensive care units (ICU), with a mortality rate of up to 40 percent.

There is only one drug other than antibiotics approved to treat septic shock, and that drug costs about $10,000 per patient. But two Canadian intensive care physicians, Dr. Ryan Zarychanski and Dr. Anand Kumar, who studied the effect of the blood thinner heparin on ICU patients between 1989 and 2005, found that patients with severe sepsis who were given heparin lowered their risk of death by 30 percent. Heparin, a generic drug, costs less than $10.

The research involved nearly 1,400 Winnipeg ICU patients with septic shock. Six hundred and ninety-five of the patients received heparin for suspected heart attacks or blood clots. Another 695 did not. The study found that there were 15 percent fewer deaths among patients who had received heparin.

Heparin for the treatment of septic shock is controversial, says Zarychanski, because it refutes the belief that expensive pharmaceuticals are the best treatment option. Thus, companies are unlikely to invest in researching it for other benefits as there is little or no profit in it.

But the safety of drugs, like heparin that is imported into the U.S. from countries like China, still hangs in the balance. It is just as important to find new treatments for less expensive drugs as it is to ensure the safety of all drugs.

SOURCE: Heparin Recall › Heparin found to reduce septic shock death rate

The active ingredient in heparin is derived from pig intestines and the demand for the drug has become so great that the domestic pig population cannot meet the demand. To meet the immediate need, pharmaceutical companies have turned to China, which has three times the pig population.

But importing drugs from China has raised some serious concerns. Earlier this year, 81 people died and hundreds more were sickened after receiving doses of heparin, which was later found to have been contaminated in a Chinese manufacturing plant.

As a result, scientists are eagerly working to develop a synthetic version of heparin that could be made in U.S. labs, thus preventing future scares. In August, we told you about Rensselaer Polytechnic Institute’s Robert Linhardt, who had just announced that after years of work his research team appeared to have successfully devised a synthetic heparin.

Linhardt and his team continue to forge ahead with the synthetic drug, according to the Scientific American. The challenge, however, is that it is hard to mass produce. It took a year for Linhardt and his team to produce 100 milligrams of the synthetic version, which pales in comparison to the more than 100 metric tons of heparin needed to meet the world’s demand for just one year.

Linhardt hopes to have a gram of synthetic heparin – or enough to give 100 doses to mice to start animal trials – within a year. Far more of the synthetic drug would be needed for clinical testing on patients, presenting a further challenge. Cost could become another issue, as heparin made from pig intestines costs only about 20 cents per dose and making the synthetic version a feasible business would take years and a huge investment.

However, Linhardt says mass production of the synthetic heparin would have benefits that far outweigh the negatives: “The future is one that will be short continuously of heparin,” he was quoted in Scientific American. “Which means any adulterations of the heparin (imported by the U.S.), we’re going to have to live with—or catch.”

SOURCE: Heparin Recall › Scientists work to overcome obstacles in synthetic heparin

The method uses a machine that removes blood from a patient through an IV, separates it into red blood cells and plasma, and returns the red blood cells back into the patient’s arm. The plasma is then infused with the blood thinner heparin, which binds to the low-density lipoprotein (LDL), or “bad” cholesterol, and separates from the plasma. The LDL is then filtered out and the remaining plasma is put back into the patient’s vein. The process filters about half of the body’s total supply of blood, removing more than half of the LDL cholesterol. The process can be repeated every two weeks as LDL builds back up.

High cholesterol, especially high LDL levels, can clog arteries to the heart and brain, which can cause heart attacks and strokes.

Innovative uses for heparin present the need for more safeguards to protect recipients of pharmaceutical medications. Batches of heparin made by Baxter International were recalled earlier this year after numerous patients died or became ill after receiving injections of heparin. The drug was later found to have been contaminated at Baxter’s Chinese manufacturing plant.

The LDL-removing treatment, which has been available in the United States for about 10 years, is generally available only to individuals with LDL levels that stay above 300 even after drug therapy, diet and exercise. However, because of its high expense and low number of eligible patients, few machines are readily available.

SOURCE: Heparin Recall › Heparin used in innovative cholesterol-separating method

Early last year, more than 80 people died and thousands more were sickened after receiving the blood thinner heparin. It was later found that specific lots had been contaminated at a manufacturing plant in China.

Even more were harmed recently when 50,000 children were sickened by milk from China that was contaminated by melamine, a product used in the manufacturing of plastics, fertilizer, paint and adhesives that can be lethal to infants.

This, just a year after parents around the world were urged to dig through their children’s toy boxes in search of Barbies, Batman action figures and Thomas the Train cars that was found to be contaminated with high levels of lead paint. The Mattel toys – which included several different products and numbered more than 21 million worldwide – were made in China. Lead paint can be especially damaging to the nervous system, cause hearing loss, stunt growth and delay development. It also can cause reproductive problems in adult men and women.

Now there is a new recall on a product made in China. The U.S. Consumer Product Safety Commission (CPSC) and Delta Enterprise Corp., just announced a voluntary recall of 985,000 drop-side cribs because of a risk of entrapment and suffocation to infants. The CPSC is aware of the death of an 8-month-old who became entrapped and suffocated, two entrapments, and nine disengagement incidents.

The recall includes selected Delta crib models manufactured in Taiwan or Indonesia between 1995 and 2005, and one model made in 2007. The cribs were sold at major retailers between 2000 and 2007. Delta cribs currently sold at retailers on not included in the recall.

Parents and caregivers are urged to stop using the cribs immediately and call Delta at (800) 816-5304 or go to www.cribrecallcenter.com for a free repair kit.

For specific model numbers, click here.

SOURCE: Heparin Recall › More products made in China recalled for harming infants

Baxter International is the world’s largest maker of blood-disease treatments. The company also sells the blood thinner heparin, which last year was recalled after batches of the drug made in the company’s Chinese plant were found to have been contaminated. As a result, more than more than 80 people died and hundreds more were made ill after receiving the tainted heparin. At that time, Baxter was the largest heparin manufacturer, with $30 million in sales.

Most of the heparin sold in the U.S. is manufactured with ingredients made in China. China is the leading supplier of the drug largely because heparin is made from pig intestines and China has a much larger pig population, according to Natural News.

At least 12 lawsuits have been filed against Baxter by patients and family members of those who suffered ill effects of the tainted heparin. As yet, Baxter has not incurred any serious legal costs from the tainted heparin crisis, Natural News reports.

In its third-quarter report, Baxter International announced that its net income increased from $395 million to $472 million, or from 61 cents a share to 74 cents a share. Much of its profit increase is attributed to international sales of products that treat hemophilia and immune disorders.

The company is predicting continued sales growth of about 5 to 6 percent, and expects cash flow from operations to exceed $2.6 billion.

SOURCE: Heparin Recall › Despite recall, Baxter International enjoys third-quarter gains

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

Italian researches carefully selected 700 of the “lowest risk” patients to participate in the trial. This included patients with single blockages of a heart artery, currently taking two clot-preventing medications such as aspirin and thienopyridine, and with no immediate danger of heart attack.

The study found that the incidence of heart damage and bleeding events were lower in the patients who participated in the study, and there was a lower risk of death, heart attack or blood vessel problems.

According to the American Heart Association, the artery-opening procedure, formerly called percutaneous coronary interventions, is a procedure used to treat patients with diseased arteries of the heart. For example, chest pain caused by a build-up of fats, cholesterol and other substances from the blood that can reduce blood flow to a near trickle or heart attack caused by a large blood clot that completely blocks the artery.

The Italian study cautioned that using no heparin is a bold step and one that should be taken only after serious consideration and evaluation of the patient’s health.

While more work is needed to confirm the results, some researches applaud efforts to move medical innovations like this forward. This is especially welcome news considering the recent contaminated heparin scare that killed more than 80 Americans and sickened hundreds more.

SOURCE: Heparin Recall › Artery procedures successfully performed without heparin

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

Linhardt was among the researchers who discovered the source of tainted heparin that was responsible for at least 149 deaths since the beginning of 2007. Manufacturer Baxter International, which supplies about half of the heparin used in the U.S., recalled its supplies of heparin made in China after more than 80 patients suffered serious allergic reactions and death following its use.

According to a report by Bloomberg News Service, Chinese pig farms that provide source material for heparin are not monitored by the U.S. Food & Drug Administration, which increases the risk for contamination. Continued use of traditional heparin products manufactured in these facilities leaves the door open for another contamination event, Linhardt says in the Bloomberg report.

In addition to Baxter’s product, a smaller scale contamination problem was reported with the Lovenox heparin medicine manufactured by Sanofi-Aventis, according to a report by Reuters.

Linhardt presented his team’s synthetic heparin results at the recent American Chemical Society meeting, according to Reuters, where he told those in attendance that today’s heparin manufacturing methods are “simply unsafe.”

Scientists are working on creating larger quantities of the synthetic heparin, which Linhardt hopes will reach human clinical trials in five years, Reuters reports.

SOURCE: Heparin Recall › synthetic heparin in development

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