Bayer Halts Sales of Anti-Bleeding Drug

A bottle of the drug Trasylol by German pharma company Bayer is seen in a hospital in Dusseldorf, western Germany, Feb. 7, 2007. Drug maker Bayer AG said Monday, Nov. 5, 2007, that it has halted the global marketing of its anti bleeding drug Trasylol after a Canadian clinical study last month found that it could be linked to a higher risk of death than other drugs. (AP Photo/Roberto Pfeil) (Roberto Pfeil - AP)

Monday's announcement came after a September recommendation from FDA advisers that Trasylol remain on the market despite its links to an increased risk of death and other serious side effects. Results from the Canadian study were not available at the time, although Lincoff and the other panel members knew it was ongoing.

The FDA's Jenkins said it was not a mistake to keep the drug on the market when FDA first learned of potential safety concerns.

"As we've learned about the safety concerns from the observational studies, we've taken those data very seriously," he said. "We've gone to two FDA advisory committee meetings for public discussion of these data."

The FDA approved the drug in 1993. It began re-evaluating the drug's safety after the January 2006 publication of two studies that linked the drug's use to serious side effects, including kidney problems, heart attacks and strokes.

More recent studies further suggested the drug also raises the risk of death. One of those studies previously was withheld by Bayer from the FDA due to what a company investigation later characterized as a "regrettable human error."

"The well-deserved, adverse publicity has forced the company to do something," FDA critic Dr. Sidney Wolfe said of the worldwide suspension.

Dr. Rafel Rieves, director of FDA's Office of Medical Imaging and Hematology, noted during Monday's briefing that the Canadian study included patients undergoing multiple types of heart surgery, beyond the specific type of bypass for which use of Trasylol is approved. He said dissecting the study will be important in further evaluating the risks and benefits of the drug.

There are not many treatment options for patients at risk for excessive bleeding during cardiac surgery, the FDA noted. The agency said it was working with Bayer to phase Trasylol out of the marketplace in a way that does not cause shortages of other drugs used for this purpose.

"Unfortunately, there's nothing like it in the pipeline" to fill the gap, and the drug was particularly useful for certain patients, the Heart Association's Gardner said.

Bayer said it wanted to review the results from the Canadian trials before moving forward.

"Once the complete (study) dataset is available, Bayer will work with health authorities to evaluate whether these data have any impact on the positive benefit-risk assessment for Trasylol," the company said. "At that time the temporary marketing suspension will be reevaluated."

Shares of Bayer rose nearly 1.2 percent to euro57.30 (US$83.02) in Frankfurt.

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Associated Press writers Matt Moore in Frankfurt, Germany, and Natasha T. Metzler in Washington contributed to this story.

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