17 More Deaths and More Recalls Associated with Heparin

The U.S. Food and Drug Administration said the number of deaths possibly associated with the drug heparin, made from pig intestines, had risen to 21 from 4. The reported number of those suffering adverse reactions increased from approximately 350 to 455. Both increases have been reported within just a 2 week time period. But the F.D.A. cautioned that many of those patients were already seriously ill and that the drug might not have caused their deaths.

Officials described the linkage of heparin to the additional 17 deaths as more tenuous than the 4 initially reported. Federal drug regulators said yesterday that they had found “potential deficiencies” at a Chinese plant that supplied much of the active ingredient for the drug. The F.D.A. emphasized that it had yet to identify the root cause of the problem, and that it had not concluded that the Chinese plant was responsible.

The agency also said it was investigating two Chinese wholesalers – also called consolidators – that supplied crude heparin to the Chinese plant, Changzhou SPL, as well as those that sold raw ingredients to the consolidators. Last week, the F.D.A. sent inspectors to the plant. Among the potential problems they found was a failure to properly follow the steps for identifying impurities and deficiencies related to manufacturing equipment.

According to a redacted inspection report released by the agency, the SPL plant appeared to have made at least some heparin with “material from an unacceptable workshop vendor.” The vendor was not identified. Some might argue that the F.D.A.’s inspections are a classic case of “too little too late.” The F.D.A. admitted earlier this month that it had violated its own policy by failing to inspect SPL before the factory began shipping the heparin ingredient to Baxter in 2004. Chinas drug agency also did not inspect the plant.

The New York Times reported yesterday that at least one of the consolidators received supplies from small, unregulated family workshops that scraped mucous membrane from pig intestines and cooked it, eventually producing a dry substance known as crude heparin. Adverse reactions to heparin have included decreased or low blood pressure and fast heart rate. Not all of them are known to involve Baxter products, but the drug agency did not issue warnings involving any other products.

The F.D.A.’s concern about heparin had previously centered on Baxter’s multidose vials, but on Thursday Baxter agreed to voluntarily recall not only the multi-dose vials but also single-dose vials and a diluted solution of heparin used to keep blood clots from forming in intravenous lines. There have been no adverse reaction reports involving the latter product, called Hep-Lock heparin flush products.

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