Baxter Heparin Deaths in Delaware Renew Concerns about Blood Thinner

The FDA is investigating two recent deaths linked to the use of Baxter heparin at one hospital in Delaware, raising concerns once again about possible contamination or other manufacturing problems similar to those that caused more than 80 heparin deaths early last year.

Last weekend, the use of heparin sold by Baxter International, Inc. was linked to the deaths of two patients and serious complications suffered by a third at Beebe Medical Center in Lewes, Delaware.

Although no specific evidence has been uncovered linking the heparin problems to contamination, concerns exist that this could be the beginning of a spike in heparin deaths and adverse reactions, similar to what surfaced in November 2007.

A Baxter heparin recall was issued in January 2008 after a sharp increase was identified with patients suffering unusual allergic-type reactions after receiving the blood thinner. Hundreds of patients suffered life-threatening reactions like severe hypotension, low blood pressure and death.

Subsequent investigations linked the problems to the presence of a fake ingredient used to make the heparin, oversulfated chondroitin sulfate. The raw heparin ingredients were manufactured in China, and FDA officials indicated that the counterfeit substance was likely used by the supplier for economic reasons, since it was cheaper to produce than the correct ingredients.

Unlike the prior heparin contamination, the issues that surfaced in Delaware involved patients suffering intracranial bleeding, not allergic reactions. In addition, the patients received the blood thinner from premixed intravenous bags, not multi-dose vials that started the heparin recall last year.

The FDA is testing samples of the heparin bags, but indicates that it appears to be an isolated incident.

According to the Wall Street Journal, Baxter indicates that the heparin linked to the deaths was manufactured from bulk material manufactured in North America, not China.