Bayer Held Back Negative Information on Antibleeding Drug
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Contributed by Lisa Olen| 01 October, 2006 22:23 GMT
A drug widely used to reduce bleeding during heart surgery, Bayer's Trasylol, may increase the risk of complications or death, suggest study results that the company did not immediately share with the FDA.
Pharmaceutical giant Bayer did not immediately provide the US
Food and Drug Administration with negative findings from a study on its heart surgery drug Trasylol because it had questions about the methods used to conduct the research and the results were preliminary, the company said.
A new analysis of records from 67,000 hospital patients suggests Trasylol might increase the risk of kidney damage, congestive heart failure, strokes and death, the FDA said.
Two earlier studies produced similar results.
The FDA is considering altering its advice to doctors on use of the medication.
Currently, the antibleeding drug is considered appropriate for use in cases where the need to reduce blood loss during coronary-artery bypass surgery outweighs potential risks.
Trasylol was administered to about 150,000 US patients in 2005. |
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