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Bayer Halts Heart Drug Sales

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By ROB STEIN, The Washington Post

Published: November 6, 2007

Updated: 11/06/2007 12:55 am

WASHINGTON - Under pressure from government regulators around the world, Bayer Pharmaceuticals announced Monday it is suspending global sales of a drug widely used to control bleeding during heart surgery after a study found 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 complete a detailed review of a Canadian study that was halted two weeks ago when a preliminary analysis indicated those given the medication were more likely to die than those given two alternative medications.

Because there are only two other drugs available, the Food and Drug Administration said it would work with the company to slowly phase out Trasylol to make sure hospitals have adequate supplies of the alternatives.

The agency also left open the possibility the drug may be permitted for specific patients if doctors say the benefits outweigh the risks.

However, the FDA "cannot identify a specific patient population where we believe the benefits outweigh the risks," said John K. Jenkins, director of the FDA's office of new drugs.

Bayer said it was working with the FDA, the German Federal Institute for Drugs and Medicine Products and Health Canada, but it maintained the medication can be used safely.

"Bayer believes that the totality of the available data continue to support a favorable risk-benefit profile for Trasylol when used according to labeling," the company said in a statement.

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 the United States received Trasylol, the company said.

The FDA did not have any estimates for how many deaths the drug may have caused.

The drug, also known as aprotinin, was approved to minimize bleeding in patients undergoing bypass surgery.

The first red flag went up in January 2006 after two studies found Trasylol increased the risk of kidney damage, heart failure, heart attacks and strokes.

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