FDA: Heparin Deaths Triple to 62 from 19 Initially Reported

By Anna Boyd
11:33, April 9th 2008
69 votes
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FDA: Heparin Deaths Triple to 62 from 19 Initially Reported

The U.S. Food and Drug Administration said Tuesday that the number of reported patients who died following heparin use has tripled since January to 62 from 19.

Heparin, made from ingredients extracted from pig intestines, is used to prevent blood clots in millions of people with heart conditions, kidney disease and in surgery.

Expanded analysis of the FDA on blood thinner heparin led to the discovery of 62 deaths associated with the drug’s reactions and not 19 as initially reported. The patients presented allergic reactions or hypotension, a type of dangerously low blood pressure, symptoms usually caused by heparin.

Baxter International Inc. sells the heparin involved in the reported deaths. The company initially recalled nine lots of its product in February, after receiving hundreds of reports of allergic reactions possibly linked to heparin. Shortly after, the company recalled all remaining heparin products.

An FDA investigation revealed that the heparin was contaminated with a man-made chemical compound known as over-sulfated chondroitin which is cheaper than heparin, but mimics it.

Erin Gardiner, representative for Baxter International, which gets the heparin from China said that the company had received reports of 38 deaths associated with the drug, but its officials maintain that four of those were the result of unexplained allergic reactions, the Associated Press reports. As for the rest of the reported deaths, Gardiner said, they were not linked to Baxter’s heparin. They were probably caused by other illnesses or conditions, or were based on information too cursory to be proved one way or the other.

FDA representative Karen Riley said the health agency decided to release the additional numbers on heparin deaths at the request of consumers. Anyone interested in the matter will find information on the agency’s Web site.

Riley also said the agency was sending a letter on Tuesday to 82 medical device manufacturers and distributors asking them to make sure any products that contain, or are coated with, heparin are also free from contamination. Some vascular stents and grafts, as well as devices used in pulmonary bypass and in-vitro diagnostic procedures, are coated with heparin.



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