-Bloomberg

11/05/2007 - Bayer AG, Germany's largest drugmaker, will stop selling its Trasylol bleeding treatment after a study linked the product to a higher risk of death than competitors.

The medicine will be kept off the market for two months or more so results from the test in Canada can be examined, the Leverkusen, Germany-based company said today. The U.S. Food and Drug Administration has been reviewing Trasylol since researchers stopped enrolling patients in the trial last month.

Bayer was criticized last year for failing to provide the FDA with data on Trasylol risks from an analysis of 67,000 patients. The analysis found patients on Trasylol had a higher risk of death, kidney failure, congestive heart failure and stroke. The drugmaker attributed the omission to an error by two employees in Germany, who were suspended.

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

The company pulled the drug after regulators in Germany, the U.S. and other countries requested the action. Bayer, which reports earnings tomorrow, said the data available now ``continue to support a favorable risk-benefit profile for Trasylol.''

Bayer rose 36 cents, or 0.6 percent, to 57.01 euros at the close of Frankfurt trading. They've risen 40 percent this year.

`Eclipsing Trasylol'

``Trasylol is old hat,'' said Martin Possienke, an analyst at Equinet AG in Frankfurt. ``The shares are reacting positively to the prospects of good results tomorrow and the report about job cuts at MaterialScience. That's eclipsing Trasylol today.''

An FDA advisory committee voted 16-1 on Sept. 12 in favor of keeping Trasylol on the market, saying the medicine's benefits outweighed the side effects seen in some patients. The findings from the latest study warrant more attention and may lead to labeling changes or other regulatory actions, the agency said.

Trasylol was first approved by the FDA in 1993. Sales of the injectable drug in 2005 were 230 million euros ($333 million) before falling 34 percent in 2006 after the patient analysis raised new safety concerns, according to Bayer's annual reports.

Bayer plans to cut expenses at its Material Science unit by 400 million euros over three years and shed jobs, the Financial Times Deutschland newspaper reported in today's edition.

Ennis & Ennis, P.A. is representing individuals that have been harmed as a result of Trasylol side effects. If you or a loved one have suffered as a result of Trasylol side effects such as kidney failure, heart attack, or stroke you may be entitled to compensation. For more information about a Trasylol lawsuit, a possible Trasylol recall, or for questions regarding Trasylol class action lawsuits click here for a free, confidential case evaluation.