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FDA Urges Limited Use of Trasylol Pending Review of Data Showing Increased Risks of Heart Attack, Stroke, and Kidney Failure

Feb 9, 2006 | Newsinferno News Staff

The Food and Drug Administration (FDA) has issued an advisory to doctors urging them to limit the use of Bayer AG’s heart-surgery medication, Trasylol, pending an agency review of research that shows the drug causes increased risks serious medical problems including stroke, heart attack, and kidney failure.

Trasylol is widely used to prevent blood loss in patients during artery bypass graft surgery (CABG).

In a statement from the FDA, Dr. Steven Galson, Director of the agency’s Center for Drug Evaluation and Research, said: "We're working to evaluate the potential risks and determine whether there is a need for further action. In the meantime, we advise providers to carefully assess the benefits and risks of the drug for their patients."

While this evaluation is conducted by the FDA, doctors are being urged to limit the use of Trasylol to those cases where the benefit of reducing blood loss during surgery outweighed the potential risks that are now being studied.

The FDA plans to hold an advisory committee meeting later this year to reassess the risk-benefit analysis in light of existing data and to determine whether additional safety measures are required.

Only last month, a report in the New England Journal of Medicine claimed that Trasylol doubled the risk of stroke and kidney failure and increased the chance of heart attack or heart failure by 55%. Bayer said the results were "not consistent with the more than 15 years of clinical data and experience Bayer has amassed on this drug."

Bayer intends to cooperate with the FDA and other regulators while it too analyzes the data. The company also plans to issue an information letter in the next few days to heart surgeons, anesthetists and hospital pharmacists about the drug.

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