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U.S. FDA: Heparin rescheduled so strong

3 October 2009 2,258 views No Comment

FDA warns that the new-and-improved heparin will take some getting used to. The blood thinner has been reformulated to help manufacturers detect any impurities, theoretically making it safer. But in the process, the drug became 10 percent less potent. So healthcare providers may have to rejig their dosages to compensate.

Making matters more confusing, older vials of heparin–original strength–will stay on the market even after the new formula–10 percent less strong–is shipped next week. The confusion is worth the risk, FDA says, because otherwise the heparin supply could run short.

Why reformulate the blood thinner in the first place? You’ll recall the big heparin snafu early last year. The blood thinner was recalled after dozens of patients experienced adverse reactions, and eventually the medical detectives traced the problem to contamination. The scandal helped expose deficiencies in the FDA’s foreign inspections process and showed the difficulties drugmakers have in tracing their product ingredients up the supply chain to their ultimate sources. Hence the reformulation. Let’s hope healthcare workers out there are paying attention.


Read more: http://www.fiercepharma.com/story/fda-reformulated-heparin-less-potent/2009-10-02#ixzz0Suxt6vQb

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