Trasylol Side Effects and Claims
Drug Overview: Trasylol Side Effects and Claims
Trasylol, manufactured by Bayer Pharmaceuticals, is an antifibrinolytic agent formerly used during coronary artery bypass graft (CABG) surgery. The main Trasylol claim was that it limited the loss of blood during surgery. The active ingredient in Trasylol is Aprotinin Bovine and the drug was administered via injection. It was approved by the FDA in December 1993 and was in use on the U.S. market for 14 years before it was withdrawn.
The FDA (Food and Drug Administration) directed Bayer to suspend marketing of Trasylol in the U.S. after the preliminary results of a Canadian study revealed that Trasylol had double the risk of death as equally effective (and much less expensive) drugs. On May 14, 2008, Bayer began removing the rest of the stock of Trasylol from the U.S. market. Trasylol is now available in the U.S. only for investigative purposes or for patients with no other options.
The FDA had known about the dangers of the drug in 2006 after a study found a high risk of kidney failure in patients given the injection. At that time the FDA required new warnings on the label, but refused to remove it from the market.
In a recent study, published in the May 29, 2008 New England Journal of Medicine, a Canadian government team found that Trasylol was twice as likely to cause death as similar, and almost equally effective, drugs. In fact, the study was stopped early for ethical reasons, as it was too dangerous to continue giving Trasylol to patients.
A 2006 study had already reported that the drug Trasylol, then widely used during coronary artery bypass graft (CABG) surgery to limit blood loss, had been associated with the following Trasylol side effects:
- Double the risk of kidney failure
- Increased risk of stroke
- Increased risk of encephalopathy
- Increased risk of heart attack
Bayer Pharmaceuticals, the manufacturer of the recently banned anti-bleeding drug, Trasylol, is facing an avalanche of lawsuits in the U.S. The FDA (Food and Drug Administration) ordered sales of the drug suspended in the U.S. when a Canadian government study was stopped for ethical reasons, because Trasylol was causing too many deaths. In May of 2008 Bayer bowed to the inevitable and began permanently removing the drug from the U.S. market.
A month before the final withdrawal began, Bayer’s CEO admitted that 78 lawsuits had been filed against it in the U.S., but none yet in other countries. This litigation may have been stimulated by a CBS 60 Minutes program aired on February, 17, 2008. The program revealed that Bayer had known about an additional study showing the dangers of Trasylol in 2006, but withheld the information from the FDA. The Harvard researcher hired to do the research blew the whistle on the company and released the information. Even then, the FDA did not take action to ban the drug. The researcher in a major 2006 Trasylol study estimates that 22,000 people died from Trasylol use between 2006 and November 2007 because the FDA failed to take action.