FDA Will Test, And May Block, Heparin Imports

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heparin1.jpgThat’s the latest plan by the agency, which is grappling with a controversy over contaminated batches of the widely used blood thinner. The version sold by Baxter International, you may recall, has been linked to nearly 800 reports of serious adverse events and 19 deaths in recent weeks and the problem has been traced to a plant in China, which the FDA failed to inspect until the scandal broke.

To cope, the FDA is now implementing new import restrictions on raw Heparin, according to Janet Woodcock, who heads the agency’s drug review division. All supplies will be tested and, if necessary, blocked from entering the US. And to ensure the policy is adopted, she says bulletins are being issued to all FDA inspectors.

heparin-fda-update.jpgIf drugmakers and their suppliers don’t test raw heparin and provide the FDA with results, the products will be held at the border until testing is completed. Testing imports will allow patients and doctors “full confidence that a potentially life-saving product like heparin is safe to use,” Woodcock told a teleconference. Look here for the FDA process for analyzing possible contaminants.

Earlier this week, Germany’s medical regulator asked all companies selling the Heparin blood thinner heparin in Germany to test all batches of their product for signs of contamination. Several other countries are now asking companies to test products, as well, according to Woodcock.

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  1. I think this issue raises another issue of how much of drugs (generic or API) originating from China can be trusted as the audit of these Chinese plant is the issue due to language barrier.

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