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Bayer safety study not disclosed to FDA

Pharma Compliance Alert, October 4, 2006

Bayer did not inform the FDA about a potentially damaging retrospective study of its drug Trasylol, even though the FDA held a public meeting to discuss the drug's safety and overall risk-benefit profile.

Bayer acknowledged last week that it made a mistake when it didn't inform the FDA about the study. According to the FDA, preliminary findings of the study may point to increased chance for death, serious kidney damage, congestive heart failure and strokes in patients who use Trasylol.

Bayer reports that it that it didn't share the study during the meeting because it was preliminary and "raised significant questions on the study population, outcomes, and methodology."

Even though the FDA didn't substantially change its recommendations for the drug, it issued a public health advisory saying it had only just learned about the new study and would continue its safety review of the drug. Go online to read the FDA's and Bayer's statements.

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