Marketing of aprotinin halted until FDA can evaluate safety

November 7, 2007

Bayer suspends worldwide marketing of antifibrolytic Trasylol.

Following results from Canadian trial BART, the FDA has decided to suspend marketing of aprotinin (Trasylol, Bayer) pending further investigation. The study was halted early because of increased risk of death in cardiac surgery patients receiving the drug. The agency plans to do a detailed review of the preliminary BART data before it decides whether aprotinin should be allowed back on the market. This action follows an FDA advisory panel recommendation in September to allow the antifibrinolytic to stay on the market despite evidence that the drug had serious adverse effects. In 2006, the FDA strengthened its warnings for aprotinin after researchers found an increased risk of kidney failure, heart failure, and stroke. The same group published a study in the Journal of the American Medical Association in February that found patients taking the drug were at a greater risk of dying over the next five years compared with patients taking aminocaproic acid and tranexamic acid. Bayer called the suspension temporary and believes that, once analyzed, the data will support a favorable risk-benefit profile for aprotinin when used according to labeling.

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