FDA Now Says Heparin Deaths Are 30% Higher Than Originally Reported

Article: FDA Now Says Heparin Deaths Are 30% Higher Than Originally Reported

The U.S. Food and Drug Administration (FDA) originally reported that 19 deaths were associated with heparin, a prescription injectable blood coagulant often used in hemodialysis (the filtering of blood) and cardiac invasive procedures. The agency now reports that the number of deaths associated with heparin is 62. That’s 30 percent higher than its original estimate.

Chart shows spike in deaths

The FDA has posted a chart on its website (www.fda.gov/cder/drug/infopage/heparin/adverse_events.htm) that shows the number of deaths reported every month from January 2007 until the present. While the chart shows that 103 deaths have been reported, 62 of them have been from an allergic type reaction which caused the current recall of heparin products.

The first ten months of 2007 saw one to two deaths per month from patients who had an allergic reaction to heparin. However, those numbers spiked from November 2007 to February 2008 (Nov. 07 – 8 deaths; Dec. 07 – 12 deaths; Jan. 08 – 16 deaths; Feb. 08 – 11 deaths). While no deaths have yet been reported for March 2008, the danger of contaminated heparin doesn’t appear to be over and the FDA says it is asking over 80 manufacturers who use heparin to check for contamination.

Liability issues

The heparin contamination issue involves many parties – the FDA, manufacturers and the Chinese factories that produce the product. But who is ultimately liable to injured consumers? Douglass Kreis, a Florida attorney whose firm protects the rights of consumers who are seriously injured due to defective drugs such as heparin, says that manufacturers should have inspected their products. He explained:

Manufacturers were clearly negligent from the standpoint of not inspecting plants and not doing presale routine analysis of the product that was being sold. I really think there was a breakdown in the post marketing surveillance.

However, we have to remember that this is really an acute event relative to some of the other litigation that we’ve been involved in. Instead of a pill that’s ingested, there is a disease process here that starts after a long duration of use or based on a certain amount of dosage. Here we have something that is being injected directly into the bloodstream and you have a very close relationship between the introduction of heparin to the bloodstream and the symptomology that stems from it.

If you’ve been injured due to heparin use, contact an attorney to discuss your situation. The consultation is free, without obligation and strictly confidential. To contact a qualified attorney whose practice focuses in this area of law, please click here.