Baxter’s multiple-dose
injectable Heparin
It was discovered that the main ingredient in some Heparin that is made in China from pig intestines was contaminated, and that some fatalities may have been caused by medical devices made with the tainted Heparin.
Baxter International, maker of Baxter Heparin, has been linked to more than 80 deaths and hundreds of adverse reactions in the U.S. As a result, there was a massive recall by Baxter earlier this year. Internationally, several other heparin makers have initiated their own recalls of suspected Heparin, because of dozens of similar reactions reported.
At least 11 deaths and 86 cases of harmful side effects reported this year in the U.S. have been linked to the use of medical devices containing the blood thinner Heparin. 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 U.S. 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 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 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.
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.
