FDA identifies heparin contaminant

WASHINGTON—The U.S. Food and Drug Administration and the Chinese government said yesterday they found a contaminant in batches of Baxter’s heparin, which could be the source of hundreds of allergic reactions and a number of deaths.

The identified contaminant is oversulfated condroitin sulfate, according to Dr. Janet Woodcock, head of the FDA’s Centers for Drug Evaluation and Research. China’s State Food and Drug Administration confirmed the finding in a March 19 statement.

The blood-thinning heparin, which is often used in dialysis treatments, is derived from pig intestines. The contaminant found is a less expensive ingredient that comes from animal cartilage and isn’t approved for use in the United States. The compound is often used as a dietary supplement to treat joint pain.

Condroitin sulfate is a compound similar to heparin and preliminary testing couldn’t initially identify it, according to Woodcock, but more demanding testing by the government and U.S. universities were able to identify it.

The FDA, however, said it could not yet “conclusively link” the contaminant to the hundreds of allergic reaction and 19 deaths associated with the affected lots of heparin.

Baxter initially recalled nine lots of heparin sodium injection multi-dose vials on Jan.17 as a precautionary measure due to a higher than usual number of reports of adverse patient reactions involving the product and suspended production. On Feb. 28 Baxter recalled all remaining lots and doses of its heparin sodium injection multi-dose, single-dose vials and HEP-LOCK heparin flush products.

The FDA never inspected the Chinese heparin plant because it confused it with another plant with a similar name. In an effort to bolster international oversight, the FDA said March 14 that it is looking to place eight staff members in China to help food and drug safety. The FDA also said on March 14 that imported heparin must be tested for impurities or will be blocked from entering into the United States.

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