FDA identifies molecule in recalled heparin that caused patient fatalities

81 deaths, 800 adverse reactions linked to Baxter’s heparin

04/23/08

On April 21, 2008, the Food and Drug Administration (FDA) reported it identified hypersulfated chondroitin sulfate, a molecule also identified as a contaminant in Baxter International’s recalled heparin, as the cause of patient fatalities. The FDA also announced that the number of deaths linked to the recalled heparin increased by 19, and now stands at 81.

FDA spokeswoman Janet Woodcock likened a patient’s reaction to the molecule to the extreme hypotension seen in some patients after being injected with contrast agents.

The contaminant was linked to China, but Chinese officials said they disagree with the FDA’s latest conclusions, and do not think the contaminant is the cause of the patient reactions. Chinese officials also question the FDA’s contention that the contaminant came from China.

Source: Peggy Peck, “FDA confirms Heparin contaminant as cause of death,” MedPage Today, April 21, 2008.

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