Tainted Heparin Used in Medical Devices Linked to 11 DeathsJun 6, 2008 | Parker Waichman LLP
Tainted Heparin made by Baxter International has been linked to more than 80 deaths and hundreds of adverse reactions in the US, resulting in a massive recall of Baxter Heparin earlier this year. Internationally, several other heparin makers have issued their own recalls of tainted heparin, and dozens of similar reactions - though no deaths - were reported in Germany. Eventually, it was discovered that the main ingredient in some Heparin, which is made in China and derived from pig intestines, turned out to be contaminated. Now, it appears that additional fatalities may have been caused by medical devices made with tainted Heparin.
At least 11 deaths and 86 cases of harmful side effects reported this year in the US have been linked to the use of medical devices containing the blood thinner Heparin. Most of the cases involved Heparin used to clean intravenous lines, said Karen Riley, a Food and Drug Administration (FDA) spokeswoman. According to Riley, the Heparin associated with two of the 11 deaths wasn't contaminated and the FDA is unable to conclusively say how most of the other deaths and side effects involved the tainted Heparin. Riley also said that she was unable to identify which companies' products were associated with the adverse reactions and deaths.
Heparin is a blood thinner administered in surgery and other critical care areas to prevent clots, is crucial in dialysis and heart surgery, and is used for the bedridden. Heparin, which has been manufactured since 1930, is administered to millions of patients yearly and Baxter manufactures about half of all multiple-dose heparin vials sold in the US. The FDA has reported that, since the end of 2007, it received over 700 reports of adverse reactions associated with Baxter's multiple-dose injectable Heparin; 40 percent of these reports were deemed serious. Reactions included difficulty breathing, nausea, vomiting, excessive sweating, and rapidly falling blood pressure that—in some—led to life-threatening shock and, in 21 cases, led to death.
The ensuing investigation revealed problems regarding inadequate FDA inspections of overseas drug and drug component manufacturers and ingredients obtained from shoddy, unregulated factories. These inadequacies served to highlight some of the critical problems going on at the FDA and have led to government investigations and hearings over FDA practices.
In addition to Baxter, companies including the device make Medtronic Inc. have voluntarily recalled products that may contain contaminated Heparin. Side effects and deaths linked to medical devices occurred between January 1 and May 14, according to the FDA's Website. Since January 2007, 81 people have died after allergic reactions, the FDA said on April 21. Riley said the 11 deaths involving devices are “probably in addition'' to the 81, though some of the reports to the FDA are “very sketchy'' and there could be “some minor overlap.''
The FDA also said contamination could lead to inaccurate test results from diagnostic devices that monitor Heparin or use it as part of the device itself.
Baxter has said the main ingredient for its heparin probably was contaminated before reaching its supplier in China.
The European Medicines Agency said today in a statement that one of its committees concluded a type of Heparin, enoxaparin, can still be used, provided that measures are taken to reduce risks. Enoxaparin was found to include a low level of contamination. Sanofi-Aventis SA's Lovenox contains enoxaparin.