FDA Recommendations Aimed At Preventing Heparin Contamination

The U.S. Food and Drug Administration (FDA) has issued recommendations aimed at preventing future heparin contamination.

The health regulator issued its recommendations to heparin makers to better ensure the blood-clot prevention drug is produced safely, said Reuters. This, following a contamination issue that affected patients world-wide four years ago. The guidance is meant to help manufacturers of heparin’s active ingredients and finished products and other involved parties, control the drug to avoid contamination, noted Reuters.

Four years ago, tainted Baxter heparin caused serious—some fatal—allergic reactions in scores of patients. Three years after the debacle, we wrote that the Chinese companies that supplied Baxter with contaminated ingredients were still sending product to the U.S. At that time, some Republican lawmakers wrote to the FDA asking why U.S. drug makers were told to avoid buying heparin ingredients from those firms.

As we’ve reported previously, Baxter International Inc. recalled nearly all its heparin injections in the U.S. in January 2008. The FDA eventually initiated 13 recalls of multiple contaminated medical products containing heparin from several companies. Eighty-one U.S. deaths were ultimately tied to the contaminated heparin.

In March 2008, the FDA confirmed that it had found oversulfated chondroitin sulfate that was molecularly changed to mimic heparin’s blood-clotting properties in samples of the active ingredient used in Baxter heparin. Chondroitin sulfate costs a fraction of the cost for the ingredient typically used in heparin, and producers may have used it in an attempt to cut costs.

Changzhou SPL, a Chinese plant partially owned by Wisconsin-based SPL, supplied the counterfeit ingredient to Baxter. Changzhou used two companies to supply it with a raw ingredient made from pig intestines, as is chondroitin sulfate. Those consolidators obtained the ingredient from unregulated workshops.

In October, we wrote that several Republican lawmakers wrote to FDA Commissioner Margaret Hamburg to voice concerns that the two unnamed companies were still importing product to the U.S. Upton’s committee reopened the tainted heparin investigation last February.

The letter stated, in part that, “We have reason to believe that these two Chinese firms are still supplying crude heparin that is being imported into the United States…. We have seen no indication that the FDA has issued warning letters and/or import alerts to these firms even though FDA has issued warning letters and import alerts to other Chinese heparin firms.”

A Committee statement also voiced concern that tainted heparin potentially poses a risk to the 12 million U.S. patients treated with the drug annually.

The FDA investigation never identified the culprits in the contamination, with the agency maintaining that there were too many sources involved in which to trace.

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