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FDA: Contaminated Heparin Directly Linked to 3 Deaths
July 30, 2008
The FDA, for the first time, has conclusively linked the deaths of three patients to contaminated lots of Heparin, a widely-used blood thinner manufactured by Deerfield-based Baxter International Inc.
On July 29th, in an interview with the Chicago Tribune, the FDA said it completed its review of 93 Heparin-related death reports the agency received earlier this year. The FDA’s investigation was initiated because there was a dramatic spike in life-threatening allergic reactions to Heparin between January and March 2008.
According to the FDA, out of 10 deaths from severe allergic reactions known as anaphylaxis or hypotension, 3 deaths could be traced to lot numbers of Baxter Heparin products that tested positive for an animal-like substance known as oversulfated chondroitin sulfate. Because Heparin lot numbers were unknown for the other 7 deaths from allergic reactions, the FDA could not determine whether those 7 patients received contaminated Heparin.
Of the remaining 83 Heparin-related death reports, the FDA stated that 13 were caused by "potential complications of Heparin use," such as bleeding, and 25 deaths were due to causes unrelated to Heparin use, such as pneumonia, sepsis and kidney failure. "In the remaining 45 deaths, clinical information in the adverse-event reports is insufficient to specify the cause of death with clinical certainty," an FDA spokeswoman told the Chicago Tribune.
In January 2008, Baxter recalled 9 types of multi-dose Heparin vials after reports of severe allergic reactions to the drug began to surface. On February 29, 2008, after scientists discovered that certain lots of Heparin were contaminated with a foreign substance, Baxter expanded the recall to include all Heparin products. With regard to the FDA’s latest analysis linking contaminated Heparin to at least three deaths, Baxter declined to comment, saying it was unable to review the relevant data.
Federal health officials and Baxter now believe the oversulfated chondroitin sulfate, which is a chemical used to treat arthritis patients, was intentionally put into Heparin by suppliers in China. Despite evidence from the FDA, Baxter and outside experts that suggests Heparin was contaminated in China, Heparin’s Chinese suppliers maintain the problem did not originate with them.
If you or someone you love has been affected by contaminated Baxter Heparin, contact our lawyers to learn about your legal rights and options.
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