BOSTON (Reuters) - 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.
In the comparison with two other cheaper drugs, tranexamic acid, sold by Pfizer under the brand name Cyklokapron, and aminocaproic acid, sold by Xanodyne as Amicar, the death rate among Trasylol patients was 53 percent higher at the 30-day mark, even though Trasylol seemed to do a slightly better job of controlling bleeding.
“Of the 108 patients who died, the proportion who were believed to have died of cardiogenic shock, right ventricular failure, congestive heart failure or myocardial infarction (heart attack) was higher in the aprotinin group than in the other two groups,” Dean Fergusson of the Ottawa Health Research Institute and colleagues wrote.
There was even a suggestion from the data that healthier patients — those under 65 and without a coexisting illness — also faced a higher risk of death, they reported.
Aprotinin treatment cost $1,200 to $1,500, compared to $150 for the other two drugs, a major savings when there are more than a million heart procedures worldwide each year.
Ray and Stein said the BART study looked at patients who were the best candidates for Trasylol. “Thus, although the existence of a class of patients who would benefit from aprotinin is not impossible, it seems highly unlikely,” they wrote.
The BART study was not the first to suggest problems with the drug. Since 2006, three studies have found evidence that it might increase the death rate, as well as the incidence of serious kidney damage and stroke.
“These three drugs have been routinely used in heart surgery for more than a decade, but this is the first trial to rigorously compare them in a meaningful setting with meaningful clinical outcomes,” Fergusson said in a statement. “The results demonstrate the great value of and the need for independent academic clinical trials.”
Additional reporting by Lisa Richwine in Washington; Editing by Maggie Fox, Tim Dobbyn, Gary Hill