Product Liability Attorney Blog

Hundreds of deaths last year were linked to tainted batches of heparin. Now, new standards for testing the blood thinner are scheduled to go into effect, Bloomberg News reports.

The nonprofit health group, U.S. Pharmacopeial Convention, which is responsible for setting standards for the quality, purity, strength and consistency of medicines, unveiled a plan that would include three identification tests and screening for organic impurities beginning Aug. 1.

In a news release, Roger L. Williams MD, UPC’s chief executive officer, stated:

“The tragedies involving heparin and glycerin demonstrate the shortcomings of 20th century safety nets in a 21st century global manufacturing supply chain. The reality is that with the decentralized, complex and global nature of today’s manufacturing environment, it is too easy for an unscrupulous supplier—driven by economic or even more frightening motives—to add an ingredient to a drug product that shouldn’t be there, putting us all at risk.

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Earlier this month, federal investigators confirmed that batches of heparin imported from China by Baxter Healthcare were tainted with a man-made chemical that led to at least 81 deaths and 152 adverse reactions in U.S. patients who were prescribed the blood thinner.

An investigative team from the U.S. Centers for Disease Control published their findings in the Dec. 4 issue of the New England Journal of Medicine.

The report concluded that illnesses and deaths were all linked to heparin made in China that was contaminated with the chemical oversulfated chondroitin sulfate. The heparin was then marketed in the U.S. by Baxter, of Deerfield, Ill.

The crisis began in November 2007 and has continued through Jan. 31, 2008.

Continue reading "CDC Confirms Heparin Deaths Linked to Baxter Imports from China" »

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After a distributor ignored repeated requests to recall contaminated heparin, the Food and Drug Administration sent U.S. marshals to the Cincinnati-based company to seize the dangerous drug.

According to an FDA press release, the marshals descended on Celsus Laboratories in early November to seize heparin sodium and heparin lithium. The sodium form is given to patients as a blood thinner. The lithium is used to coat medical devices in order to prevent blood from clotting on them.

Almost 250 deaths have been linked to raw heparin imported from China. Heparin, derived from pig intestines, is typically injected into patients to reduce the risk of blood clots in catheters or during kidney dialysis and cardiac surgery.

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According to a report released by the nonprofit Institute for Safe Medication Practices, the U.S. Food and Drug Administration received a record number of adverse drug-reaction reports in the first quarter of 2008.

The FDA received almost 21,000 serious adverse reactions in the first three months of 2008, including 4,800 deaths.

Chantix, Pfizer’s anti-smoking drug, and the blood thinner heparin were the two drugs that accounted for highest number of serious problems.

Continue reading "Heparin Highlighted in Serious Drug-Reaction Report" »

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The U.S. Food and Drug Administration will open an office in China before the end of the year, according to a statement released by the federal government last week.

The FDA’s first office will open in Beijing and subsequent outposts are planned for Shanghai and Guangzhou, the Associated Press reports. A total of eight staffers are expected to man the three offices.

In addition to China, food and drug regulators are expected to be placed in India, Latin America and the Middle East.

The announcement comes after the safety of imported food and drugs has come under fire. There have been at least 149 deaths in the U.S. of people who had allergic reactions after receiving contaminated doses of the Chinese-made blood thinner heparin.

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The Food and Drug Administration recently identified the blood-thinning drug heparin as one of 20 medications with potential safety issues.

According to a statement released last Friday, the FDA noted that in the first three months of 2008, heparin was associated with anaphylactic-type reactions. Anaphylaxis is a severe, whole-body allergic reaction that can be fatal. Symptoms range from nausea and diarrhea to shortness of breath and dangerously low blood pressure. By June, 149 deaths in the U.S. had been linked to heparin.

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More than a hundred people have died as a result of receiving heparin contaminated in Chinese factories. Now, the U.S., Europe and Australia have agreed to coordinate the inspections of drug-making factories in China and India, the Associated Press reports.

The pilot program was announced on July 9. It is hoped that the effort will allow regulators to inspect more factories.

Inspections are urgently needed. There have been at least 149 deaths in the U.S. of people who had allergic reactions after receiving contaminated doses of the blood thinner heparin. So far, ten countries have reported the presence of contaminated heparin. They include: Australia, Canada, China, France, Germany, Italy, Japan, The Netherlands, New Zealand, and the United States.

Continue reading "U.S., Europe and Australia Team Up to Inspect Chinese Factories" »

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The number of U.S. deaths involving an allergic reaction to the blood thinner heparin has risen to 149.

On Monday, the Food and Drug Administration posted the revised death toll on its web site. In April, the number of deaths in people who had allergic reactions was 81. The latest figures include seven deaths in April and five in May.

There were a total of 246 reports of deaths in the U.S. of people who had received heparin. Of that number, 149 suffered allergic reactions.

Continue reading "Heparin-linked Death Toll Rises" »

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An international team of researchers led by the Massachusetts Institute of Technology has explained why tainted heparin is so deadly.

Heparin is a blood thinner produced from pig intestines that is often used during kidney dialysis or heart surgery. Recently, 81 patients died after receiving heparin in which chondroitin sulfate was substituted for the active ingredient derived from pig intestines

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In an op-ed piece in today’s issue of the News & Observer, pharmacist David Work writes that the recent illnesses and deaths linked to contaminated heparin exposes weaknesses in the drug manufacturing process in the United States.

Work, a retired executive director of the North Carolina Board of Pharmacy, notes that in today’s global economy, the Food and Drug Administration has neither the funds nor support to ensure that the nation’s prescription drug supply is safe.

Continue reading "Toxic Heparin Exposes Drug Safety Issues " »

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After discovering that contaminated heparin is still available in some hospitals, medical centers and pharmacies, the U.S. Food and Drug Administration renewed its efforts to recall the tainted blood thinner last Friday.

On May 9, the FDA sent out a notice requesting “health professionals and facilities review and examine all drug/device storage areas, including emergency kits, dialysis units and automated drug storage cabinets to ensure that all recalled heparin products have been removed and are no longer available for patient use.”

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Despite requests from congressional investigators, the U.S. Food and Drug Administration refused to turn over a list of Chinese heparin suppliers, the Wall Street Journal reports.

The request was made as part of a House subcommittee probe into the circumstances surrounding more than 81 deaths in the U.S. linked to contaminated heparin. The FDA refused to identify the Chinese suppliers, claiming that a confidentiality agreement bars them from releasing the information.

Continue reading "FDA Keeps List of Chinese Heparin Suppliers a Secret " »

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Today’s issue of the Baltimore Sun reveals what it is like to be a patient the end of the contaminated heparin supply chain.

In “Drug safety crisis hits home,” Claire Panosian Dunavan relates her cousin’s recent experience after she received heparin in a U.S. hospital. The cousin, Laura, was rushed to the emergency room after a dangerous blood clot known as a deep vein thrombosis, a serious condition that can cause death, was discovered. To counteract the clot, she was given the blood thinner heparin.

Dunavan writes:

“As soon as a nurse started her anticoagulant drip, Laura thought she was dying.

‘I never felt so terrible in my life,’ she later recalled. Sweaty and breathless, her chest and bowels heaving, she pressed her call button and yelled for help.’”

Continue reading "The Impact of Tainted Heparin" »

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