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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.

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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.

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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.

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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.

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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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