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

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

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

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

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

The study also reported, “the use of heparin manufactured by Baxter Healthcare was the factor most strongly associated with reactions (present in 100 percent of case facilities vs. 4.3 percent of control facilities).” Those facilities included 21 dialysis facilities that reported reactions and 23 facilities that had no reported reactions. Adverse reactions reported included hypotension, nausea and shortness of breath. Most symptoms presented within 30 minutes of administering the drug.

All of the facilities that reported adverse reactions had vials of heparin manufactured by Baxter Healthcare that were contaminated with OSCS, according to the report. Researchers found that of the 130 reactions for which information on the heparin was available, more than 98 percent occurred in a facility that had OSCS-laced heparin on premises. Of the 54 reactions for which the lot number was known, the report shows that 96.3 percent occurred after the patients received the OSCS-tainted heparin.

According to the report, “Heparin contaminated with OSCS was epidemiologically linked to adverse reactions in this nationwide outbreak. The reported clinical features of many of the cases further support the conclusion that contamination of heparin with OSCS was the cause of the outbreak.”

SOURCE: Heparin Recall › CDC study provides details on OSCS-laced heparin

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

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

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

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 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

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

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

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

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

“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

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