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Sales of the heart surgery drug Trasylol are being suspended as concerns continue to mount over the increased risk of death, the Food and Drug Administration announced Monday.

The FDA action comes just weeks after a Canadian study was halted amid growing evidence of the drug's mortality risks.

Trasylol , approved in 1993, is sometimes given to heart surgery patients to reduce blood loss and prevent the need for a transfusion. However, the drug has been linked to serious risks including kidney failure, heart attack, and stroke since early 2006.

Studies Highlight Risks

In January 2006, the New England Journal of Medicine published the first study to draw attention to Trasylol's safety. The study found a twofold risk of kidney failure, as well as an increased risk of heart problems, and the authors concluded “continued use is not prudent.”

Despite the drug's risks, an FDA advisory panel voted in September 2006 to keep Trasylol on the market. The labeling of the drug was updated several months later to warn about the risk of kidney failure and to recommend a more limited use.

Then in 2007, Trasylol was linked to a higher risk of death by a study in the Journal of the American Medical Association . Again, an advisory committee recommended the drug remain on the market.

The preliminary findings of a Canadian study late last month also showed an increased risk of death associated with Trasylol compared with competing drugs, and that study was stopped as a result.

Congress and plaintiffs attorneys will likely question the delayed action, given that the drug has been on the market for over a decade.

(Source: Wall Street Journal online)

Injured by Trasylol? If you suffered injury or your loved one died and you suspect Trasylol is to blame, contact an experienced attorney for a free case evaluation. You may be entitled to compensation for your losses.