UPDATE: FDA releases revised death count from heparin contamination
The Food & Drug Adminstration (FDA) recently reviewed adverse events related to heparin, which has been the subject of much scrutiny after 19 deaths were reported due to allergic reactions from contaminated vials. Since January 2007, the FDA has received reports of 103 deaths from people taking heparin, 62 of which involved allergic reactions or hypotension (dangerously low blood pressure). These deaths include people who were taking all brands of heparin, not just the brand affected by the contamination and recall. The manufacturers of the brand that was contaminated and recalled says that they know of only 4 deaths assocciated with their contaminated product. The FDA has stated that this does not mean that the deaths were necessarily caused by the allergic reactions and low blood pressure. Although allergic reactions and low blood pressure were the cause of death of those who have died from the contaminated vials, it’s not clear that all 62 deaths are associated with contaminated heparin. In fact, heparin carries a warning detailing risk of low blood pressure. However, in the year 2006, only 55 deaths were reported from heparin, and only 3 were due to allergic reactions. So there is obviously something that is increasing the number of allergic reactions to heparin. Hopefully the increase in deaths is due to the contaminated heparin that has already been recalled from the market, but it’s possible that there are other issues, or other brands that are also contaminated. The FDA continues to investigate, and hopefully can provide answers soon, especially to the people who depend on heparin for their well-being.
The previous blog entry shows an intermediate level Cause Map (root cause analysis) as a downloadable pdf.