U.S. panel backs use of Bayer heart surgery drug
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Bayer AG’s drug Trasylol provides acceptable safety and effectiveness for preventing blood loss in certain patients undergoing heart bypass surgery, a U.S. advisory panel said on Thursday.
The Food and Drug Administration advisers voted in favor of Trasylol after reviewing data on heart attacks, strokes, kidney damage and allergic reactions in people treated with the drug.
The experts from outside the FDA agreed Trasylol treatment appeared linked to a higher rate of kidney dysfunction but many questioned the validity of research that found a connection to heart attacks and strokes.
“I think the totality of evidence does support its use,” said Dr. William Hiatt, the panel chairman and a vascular medicine specialist at the University of Colorado Health Sciences Center.
In February, the FDA urged doctors to limit Trasylol use while the agency evaluated two studies linking the drug to kidney problems. One of the studies said Trasylol could increase the chances of heart attacks and strokes as well.
FDA reviewers said they also became concerned by the number of fatal allergic reactions reported. A total of 51 have been recorded, including 10 in 2005.
Agency officials asked the panel for input as they decide if new warnings or other steps are needed.
Trasylol, known generically as aprotinin, is given by injection to prevent blood loss during cardiac bypass surgery. It won U.S. clearance in 1993 and is the only FDA-approved medicine for that use, although doctors often turn to two older, generic drugs for the same purpose, experts said.
Between 10 percent and 20 percent of all blood transfusions in the United States occur during heart surgery, which strains the blood supply and poses some risks to patients, Bayer said.
Eighteen panel members supported continued use of Trasylol in heart bypass patients, and one abstained from voting. Several said Trasylol should be reserved for patients considered at high risk of bleeding.
“I think there still needs to be caution in not using it routinely in everyone,” said panel member Dr. Norman Kato, a cardiovascular surgeon at Cardiac Care Medical Group in Encino, California.
Bayer said it had proposed adding information about kidney risks to the drug label but believed the drug’s benefits still outweighed the risks.
The German company also said it was developing a test it hoped could identify patients at risk for an allergic reaction. Trasylol already carries a strong “black box” warning that a fatal allergic reaction could occur, and doctors are urged to give a small test dose first.
The company and several panelists criticized a study, published in the New England Journal of Medicine in January that concluded Trasylol raised the chances of suffering a heart attack or stroke. They said the researchers might not have accounted for other factors that could be to blame.
“I think this drug is fairly neutral” on problems such as heart attacks and strokes, Hiatt said.
The lead author of that study, Dr. Dennis Mangano, defended his results to the panel and said continued use of Trasylol was “not prudent.”
Trasylol sales were 75 million euros ($95 million) for the first half of 2006. In December 2005, Bayer predicted the drug’s annual sales could reach more than 500 million euros ($635 million).
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