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FDA Panel Will Review Trasylol Safety

Sep 10, 2007 | Associated Press | Forbes News

Federal regulators have scheduled a meeting to review the safety of Bayer AG's blood-clotting drug Trasylol, which has been under government scrutiny for more than a year.

The Food and Drug Administration will ask a group of outside experts on Sept. 12 to look at data suggesting Trasylol can cause kidney damage, heart failure and even death, according to a posting on the FDA's Web site Wednesday.

The agency held a similar meeting last September, after which Bayer (nyse: BAY - news - people ) said two employees decided to withhold additional information about Trasylol's side effects. Bayer condemned the decision and said last week that an outside investigation concluded the employees did not intend to mislead regulators.

Trasylol is used to reduce blood loss during coronary artery bypass surgery. The FDA added safety warnings to the drug's labeling late last year, stating that doctors should only use it in patients who have an elevated risk of blood loss during surgery.

The FDA's outside panelists could recommend more restrictions next month on when and how the drug should be used. Although the FDA is not required to follow the recommendations, it generally does.

Annual sales of the drug fell 33 percent to $195 million in 2006 compared with the prior year.

Shares of Bayer AG rose 79 cents to $76.79 in morning trading.