FDA Targets Heparin Safety in New Proposed Guidelines

Posted on February 22, 2012

Four years after contaminated batches of the widely used blood-thinning drug heparin were implicated in some serious adverse reactions and deaths, the Food and Drug Administration (FDA) has issued recommendations to ensure the safe production of the drug.

The proposed guidelines —which target manufacturers of the active ingredients, finished product, and others — are designed to improve quality-control procedures to prevent future contamination of heparin. Contamination involving the active ingredient oversulfated chondroitin sulfate (OSCS), which was made in China, was blamed for the 2008 heparin scare, which resulted in 785 serious injuries and 81 deaths. The incident raised an outcry in the U.S. over lack of oversight and inspections in foreign facilities.

Heparin, which is widely injected into kidney dialysis patients to prevent blood clots, is naturally derived from pig intestines. OSCS, which can mimic heparin, does not occur naturally and is man-made. The FDA’s guidance document declared that, “OSCS contamination of heparin appears to be an example of intentional adulteration, and has also been referred to as economically motivated adulteration.”

In other words, it was done purposely to cut production costs.

The FDA draft document recommends that every shipment of crude heparin be inspected for OSCS before it is manufactured. It also suggests that heparin manufacturers regularly audit their suppliers.

Keeping Drugs Safe

We applaud the FDA’s recommendations to make our drug-supply chain safer. However, the fact remains that many people were injured or killed as the direct result of intentional drug adulteration. Why? Just to save some money. The Florida heparin injury lawyers at Farah & Farah believe that this kind of behavior is inexcusable and should not stand. Ever. If you or a loved one has been harmed because of willful negligence by a manufacturer, call us at (800) 533-3555.


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