FDA: We Don't Want Another Heparin Incident

By Lori Clapper, Editor

Last Friday, the FDA released new draft guidance on the safe production of the blood-clot prevention drug heparin, four years after discovering contaminants in heparin API (active pharmaceutical ingredient) imported from China. In the document, the FDA notes that the contamination could have been economically driven — the Chinese API manufacturer intentionally tainted the drug with oversulfated chondroitin sulfate (OSCS), a chemical that mimics the drug, to lower costs.

The FDA began receiving reports of adverse reactions to heparin in January 2007, and the drug was blamed for 149 deaths by May 2008. Investigators traced the problem to China, where small, unregulated farms supplied the pig intestines used to make the heparin. The agency also found that batches of the tainted drug were supplied by Baxter Healthcare Corporation, who later recalled multidose and single-dose vials of heparin sodium, according to a Reuters report. This case sparked concerns over the lack of inspection of foreign pharmaceutical manufacturers and safety in the supply chain.

The FDA designed the new recommendations to “help API manufacturers, pharmaceutical and medical device manufacturers on finished products, repackers, and others to better control their use of crude heparin that might contain oversulfated chondroitin sulfate or non-procine material (especially ruminant material) contaminants.” Because there is still potential risk for contaminated heparin, the FDA advises manufacturers to confirm the species origin of crude heparin, test for OSCS before the drug is manufactured, ensure their suppliers adhere to cGMP, and reject and properly dispose of contaminated products. Manufacturers should also refer to ICH Q7 guidelines to prevent the use of tainted heparin.