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May 14, 2008
Bayer AG is removing remaining supplies of its heart-surgery drug Trasylol from the U.S. market after a long-awaited study found it raised the risk of death compared to two alternatives, U.S. regulators said on Wednesday.
The announcement followed publication earlier on Wednesday of a Canadian study by the New England Journal of Medicine that showed patients given Trasylol had a more than 50 percent higher death rate than patients who got other, cheaper drugs.
“Thus, in all likelihood, this is the end of the aprotinin story,” Dr. Wayne Ray and Dr. Michael Stein of Vanderbilt University in Tennessee wrote in a commentary on the study.
The expensive drug, also known by its generic name aprotinin, has been widely used since the 1990s during heart bypass surgery to reduce bleeding. Bayer pulled the drug in November, saying it would reevaluate its options once details from the new study, known as BART, were released.
The Food and Drug Administration said on Wednesday Bayer had notified the agency that it would begin removing remaining Trasylol stock from the U.S. market. Access will be limited to investigational use for certain patients who have no acceptable alternatives, the FDA said.
The FDA “supports Bayer’s decision to completely remove Trasylol from regular use in the U.S. market,” the agency said.
Bayer said it was removing Trasylol supplies from all countries where it remained in the supply chain, except where local authorities wanted to keep it in the market for special access programs.
The drugmaker “will work with health authorities to determine what impact, if any, the BART data and any other new data will have on the benefit-risk profile of Trasylol,” Bayer spokeswoman Staci Gouveia said by email.
Continue reading, Bayer pulls Trasylol supplies after study reveals increased risk of renal failure, dialysis and death after open-heart surgery.