The blood clotting drug Trasylol will no longer be sold by Bayer AG after studies have shown there is an increased risk of death from using the drug. The recalled drug increases the risk of kidney damage when used during heart bypass surgery.
The FDA cannot identify a patient population in which the use of Trasylol (aprotinin) outweighs the risk, Dr. John K. Jenkins, director of the FDA’s Office of New Drugs, said at an early morning news conference Monday.
However, he added, “the suspension will include a slow phase-out of Trasylol from the marketplace to decrease the possibility of shortages of the alternative drugs.” And he added that Bayer could continue to supply the drug if physicians can identify specific patients who would benefit from it.
A drug study in Canada was stopped after more patients were put at risk than benefitted from using the drug. Trasylol has been used around the world in cardiac surgeries.