Bayer to remove Trasylol from the market, FDA

Bayer HealthCare Pharmaceuticals Inc. is going to remove the remaining supplies of its heart-surgery drug, Trasylol from the market. This has been decided after a study on this drug revealed that it increased the risk of death, heart attack and kidney failure as compared to two other drugs.

"Thus, in all likelihood, this is the end of the aprotinin story," wrote Dr. Wayne Ray and Dr. Michael Stein of Vanderbilt University in Tennessee.

This study compared Trasylol, also known as aprotinin, and two other drugs that are used to prevent massive blood loss during heart surgery.

The study was conducted on 2300 patients who were chosen randomly to receive Trasylol or two other anti-bleeding drugs during heart surgery. The study was stopped in October 2007 when preliminary results showed that the patients receiving Trasylol had a higher death rate.

"There was no way we could ethically enroll (more patients) in the trial because we had our answer," said lead researcher Dean A. Ferguson, a transfusion medicine expert at the Ottawa Health Research Institute. "I think the results are quite definitive, certainly for high-risk cardiac surgery, and it's going to be very tough to justify its use in lower-risk surgery."

The researchers found that Trasylol increased chances of death by 54 percent as compared to two other drugs. Six percent of the Trasylol patients died within 30 days of surgery, compared with 4 percent who got either Amicar or Cyklokapron.

In November, Bayer made an announcement that it was temporarily taking the drug out of the market.

Trasylol was approved for use to prevent blood loss in 1993. There were no negative reports of the drug until 2006, when one large study linked it to increased risk of death, heart attack, stroke and kidney failure.

The Food and Drug Administration said that it has been notified by the company that it is going to remove the remaining drug out of the market.

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 drug maker "will work with health authorities to determine what impact, if any, the study data and any other new data will have on the benefit-risk profile of Trasylol," Bayer spokeswoman Staci Gouveia.