The FDA had violated its own policy: Adverse drug reactions from defective heparin

Baxter International announced recently that it is recalling virtually all its heparin products. Baxter makes and sells more than 500,000 multi-dose vials of heparin in the U.S. each month. Heparin is used to prevent blood from clotting during dialysis and some common forms of heart surgery.

More than 400 adverse reactions have already been reported in the US from the use of heparin, including up to 21 deaths. Investigators are trying to identify the root cause, which seems related to the practices of small Chinese suppliers of crude heparin.

To make heparin, workers collect and cook the mucous membrane from the intestines of slaughtered pigs, producing crude heparin. Major producers refine that and sell it to Baxter and others, which make the finished product for use in hospitals.

Blue ear pig disease has swept through China, depleting stocks, and leading some farmers to sell sick pigs. This led companies to switch to using small, often unsanitary and unregulated village workshops as less expensive suppliers. As much as 70% of China’s crude heparin now comes from such small factories in poor villages.

The FDA had admitted this month that it had violated its own policy by failing to inspect Changzhou SPL, located west of Shanghai, before the factory began shipping crude heparin, an ingredient of the medicine heparin, in 2004. The Chinese government does not inspect such factories.

Advice to heart surgery and dialysis patients: Ascertain, or ask your patient advocate to ascertain, the source of the heparin you will receive. A sufficient supply is available from safer suppliers.

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Thanks to Walt Bogdanich and David Barboza for the two source articles in last week's NY Times.