Bayer's Trasylol Under Review by the FDA

The FDA has issued a statement about Bayer drug Trasylol. Trasylol is used to reduce bleeding and prevent the need for blood transfusions during certain types of heart surgery.

The FDA has been reviewing the safety of the drug since January 2006 after studies showed the drug may increase the risk of kidney failure, heart attack, and stroke. They held a public Advisory Committee meeting on Sept. 21, 2006 to discuss safety findings.

On Sept. 27, 2006, six days after the Advisory Committee meeting, Bayer Pharmaceutical informed the FDA about the results of a new study that found Trasylol "may increase the chance for death, serious kidney damage, congestive heart failure and strokes."

The FDA says they will continue to evaluate the safety of Trasylol and that physicians should in the meantime exercise caution when using the drug.

FDA Statement Regarding New Trasylol Data

Filed under Bayer, Drug Company Ethics

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