Sales of Heart-Surgery Drug Halted

Anti-bleeding med yanked after study shows higher death risk
By Nick McMaster,  Newser Staff
Posted Nov 5, 2007 9:35 PM CST

(Newser) – Bayer Pharmaceuticals will suspend the sale of Trasylol, a drug used to control bleeding during heart bypass surgery, after a clinical study found that the drug puts patients at increased risk of death, the Washington Post reports. The FDA said sales of the drug would be halted at least until the agency had reviewed the study.

The drug has raised concerns at least since 2006, when an agency safety review led to  new warnings on its label. Few substitutes are available, so the FDA plans to slowly phase out sales to avoid shortages. The agency also said the drug may ultimately be approved for specific patients for whom the benefits outweigh the risks.