Number of heparin death reports received by FDA increased to 62

According to data released this week, the FDA has received reports of over 100 heparin deaths since January 2007. The reports included 62 deaths involving allergic symptoms or problems associated with hypotension, which were likely caused by a contaminated ingredient contained in heparin sold throughout the country. This most recent data represents a sharp increase over the 19 previously reported deaths associated with the recalled blood thinner.

>>INFORMATION: Heparin death and allergic reactions

The number of adverse event reports received by the FDA involving heparin deaths has skyrocketed since November 2007. This probably signals when contaminated batches of the blood thinner entered the United States and started causing serious and life-threatening reactions. Thousands of people have experienced problems after receiving heparin, with symptoms such as:

• Low Blood Pressure
• Shortness of Breath
• Nausea and Vomiting
• Diarrhea and Abdominal Pain

The problems appear to have been caused by a fake chemical ingredient which was found in raw heparin made at a Chinese plant owned by Wisconsin-based Scientific Protein Laboratories. As a result of the contamination, a nationwide Baxter heparin recall was issued in February 2008 and a Covidien prefilled heparin syringe recall was issued last month. Similar heparin recalls have been issued in Germany and Japan as a result of contaminated heparin made from raw ingredients produced at the same China plant.

In prior years, the FDA has rarely received reports of deaths associated with allergic reactions involving heparin, with only 3 in all of 2006. Late last year, red flags were raised when 8 reported heparin deaths were received in November 2007 which involved allergic reactions. The agency received additional reports of 12 deaths in December 2007, 16 deaths in January 2008 and 11 in February 2008. After the contaminated heparin was removed from the market in February, the agency received no reports of associated deaths in March 2008.

The true number of heparin deaths linked to contaminated blood thinner is likely much higher than the official reports received by the FDA. It is generally accepted that reported adverse events received by the FDA only represent 1% to 10% of all problems which actually occur.

HEPARIN DEATH LAWSUIT

The lawyers at Saiontz & Kirk, P.A. are investigating potential lawsuits for individuals who have died or suffered life-threatening injuries after receiving the blood thinner. To determine if you, a friend or family member may be eligible for compensation through a heparin lawsuit, request a free consultation.