FDA unsure about contaminant in heparin

WASHINGTON The Food and Drug Administration stated that a yet unknown contaminant was found in batches of the active ingredient used in Baxter International’s blood thinner heparin, according to the Wall Street Journal. Baxter stopped manufacturing the drug last month and recalled some of its heparin products as a result.

FDA officials said 19 reports of death, up from a previous total of four, now appear to match the allergic-type and low blood-pressure reactions that have been the main focus of safety concerns. It wasn’t clear how many of the 19 people took the Baxter product. The deaths occurred since Jan. 1, 2007, but the FDA only received the reports in the past three months or so, the agency said.

Baxter yesterday said it believed four patients had “suffered an allergic-type reaction to heparin that may have contributed” to a fatal outcome.

Rival heparin maker APP Pharmaceuticals said it hasn’t gotten any reports of allergic-type reactions of the type Baxter and the FDA are describing. The agency said it has now received a total of 785 reports of problems in patients who took some form of heparin, though it isn’t clear that these are all related to drug reactions and some may be duplicates.

FDA officials said there was an “association” between batches with the contaminant and patient reactions, but the agency hasn’t yet concluded there is a direct causal link. It said the source of APP’s active ingredient hadn’t shown a similar contaminant.

Baxter said the questionable heparin had been made from a Chinese raw ingredient. The unknown substance was a “natural or biologic material,” and there is currently “nothing to substantiate” a conclusion that it was a counterfeit product, a company spokeswoman said.