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Bayer Pharmaceuticals' Trasylol, a drug used to control bleeding in heart bypass patients, will undergo a second safety review on Wednesday after two studies showed it could increase the risk of death. Already the subject of an ongoing FDA review after two studies last year suggested the drug, approved in 1993, doubled the risk of kidney failure and carrying the FDA's strictest "black box" warning, the agency will meet "to provide recommendations about the overall risk-benefit assessment for Trasylol, especially when considering the information that was not provided to the 2006 advisory committee." One of the latest studies had been given to Bayer before an FDA panel meeting in September 2006, but Bayer didn't submit the findings until after the meeting. Bayer has said it did not release the study of some 67,000 hospital records to the FDA because the results were preliminary, though it has suspended two senior staffers over the issue. That study found that Trasylol increased the risk of death by 54%, according to the FDA. The agency is now reviewing the final results of the so called I3 study recently submitted by Bayer. The drugmaker, in documents posted on the FDA Web site, admitted that the drug seemed to be associated with "renal dysfunction" but said it did not appear to be associated with a higher death risk. Trasylol is the only FDA-approved drug to prevent blood loss during bypass surgery. Originally projected to generate sales of more than $500M, the drug has disappointed Wall Street because of the safety issues surrounding it.

Sources: Reuters, Wall Street Journal
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Source: Another Safety Review on Tap for Bayer's Trasylol -- FDA Panel