Bayer pulls anti-bleeding drug due to safety worries
WASHINGTON - Under pressure from government regulators around the world, Bayer Pharmaceuticals announced Monday that it is suspending global sales of a drug widely used to control bleeding during heart surgery after a study found that patients receiving the medication were at increased risk of dying.
U.S., German and Canadian regulators pushed Bayer to stop selling Trasylol until authorities could review a Canadian study that was halted two weeks ago when a preliminary analysis indicated that those given the medication were more likely to die than those given two alternative drugs.
Because there are only two other drugs available for such patients, the Food and Drug Administration said it would work with the company to slowly phase out Trasylol to make sure hospitals have the adequate supplies of the alternatives.
“FDA cannot identify a specific patient population where we believe the benefits of using Trasylol outweighs the risk,” Dr. John Jenkins, director of the agency’s Office of New Drugs, said Monday.
More than 4.77 million patients have received the drug since it was approved in 1993. In 2006, approximately 110,000 U.S. patients and 87,000 patients outside of the U.S. received Trasylol, the company said. The FDA did not have any estimates for how many deaths the drug may have caused.
The FDA approved the drug in 1993. It began re-evaluating the drug’s safety after the January 2006 publication of two studies that linked the drug’s use to serious side effects, including kidney problems, heart attacks and strokes.
More recent studies further suggested the drug also raises the risk of death.
Information from The Associated Press is included in this report.