Despite being linked to increased risk of death and other serious side effects, federal advisers voted 16-1, with one abstention, to recommend allowing sales of the a Bayer AG drug sold under the brand name Trasylol.
Trasylol received an FDA approval in 1993 to stanch the loss of blood and prevent the need for blood transfusions in surgeries to bypass clogged coronary arteries. It Trasylol(R) is the only drug currently approved by the FDA for this purpose.
But the federal agency has been re-evaluating the drug's safety since the January 2006 publication of two studies that linked the drug's use to serious side effects, including kidney problems, heart attacks and strokes.
The FDA advisory panel held the recent meeting to analyze such risks and it could possibly lead to restricted use of the drug. Though the agency is not bound to follow the advice of its advisory committees but does so most of the time.
Recommending that there is a further need to study the drug for its safety, FDA panelists recommended that Bayer amend the U.S. product label for Trasylol to provide additional prescribing guidance to physicians.
Trasylol works by blocking enzymes that dissolve blood clots. It is used in patients with a known or suspected aprotinin exposure during the last 12 months.
Bayer, of Germany, has issued statements conceding that the drug appears to be associated with renal dysfunction, but added that its association with kidney failure is not as definitive.
The company also adds that a data from its global clinical database and a meta-analysis of randomized, controlled trials do not indicate a mortality risk. The drug already has a black box warning.
