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KEYCODE BAYER #280

Dec 15, 2006

Bayer drug carries tougher kidney warning - FDA

Bayer AG's heart-surgery drug Trasylol will now carry a stronger warning that the drug increases the risk of kidney damage, the U.S. Food and Drug Administration said on Friday.
The FDA also said the drug's label now calls for limiting its use to patients at an increased risk for blood loss during coronary bypass graft surgery using a machine to take over heart functions.
The FDA said future warnings may also be needed.
Preliminary data from a study that Bayer previously failed to give the agency showed Trayslol could increase the risk for death, congestive heart failure and strokes.
Shares of Bayer were down 67 cents, or more than 1 percent, at $52.74 in afternoon trade on the New York Stock Exchange.
Trasylol has been at the center of an FDA safety review since two published studies linked the drug's use to kidney problems earlier this year. The agency held a public meeting in September over the concerns, but Bayer did not provide another study for review. The drugmaker later provided the data.
"The purpose of the label change is to inform physicians and patients about the risks associated with Trayslol and to ensure they understand the new warnings and use the product as directed by the label," Dr. Steven Galson, head of FDA's Center for Drug Evaluation and Research, said in a statement.

FDA News, December 15, 2006

FDA Revises Labeling for Trasylol (Aprotinin Injection) to Strengthen Safety Warnings and Limit Usage of Drug to Specific Situations

The U.S. Food and Drug Administration (FDA) today approved revised labeling for Trasylol (aprotinin injection) to strengthen its safety warnings and to limit its approved usage to specific situations. Trasylol is given to patients before heart surgery to reduce bleeding and the need for blood transfusions. Trasylol is marketed by Bayer Pharmaceuticals Corporation, Leverkusen, Germany.

"The purpose of the label change is to inform physicians and patients about the risks associated with Trayslol and to ensure they understand the new warnings and use the product as directed by the label," said Dr. Steven Galson, Director of FDA's Center for Drug Evaluation and Research.

The new labeling specifies that Trasylol should only be given to patients who are at an increased risk for blood loss and blood transfusion in the setting of coronary bypass graft surgery (a procedure used to improve blood flow to the heart) when patients undergo cardiopulmonary bypass (a procedure that allows a machine to take over the heart's functions when it is stopped during surgery). The changes also include a warning that Trasylol increases the possible risk for kidney damage, and suggest ways to manage and reduce the patient's risk for hypersensitivity (exaggerated immune) reactions.

The labeling changes follow an FDA-conducted review of safety information that FDA became aware of after the product was introduced to the market. FDA began this safety review of Trasylol in January 2006. The review was triggered by the results of two published research studies. One study reported an increase in the possibility of kidney failure, heart attack and stroke in patients treated with Trasylol compared to those treated with other drugs. The other study reported an increase in the possibility of kidney damage compared to other drugs, but did not show an increased risk of heart attack or stroke. On February 8, 2006, FDA issued a Public Health Advisory regarding these new findings with Trasylol. On September 21, 2006, FDA held a public meeting of the Cardiovascular and Renal Drugs Advisory Committee to discuss the safety and overall risk-benefit profile for Trasylol. At that meeting, the committee discussed the findings from the two published observational studies, a Bayer worldwide safety review, and the FDA review of its own post-marketing database, and made recommendations for labeling changes. The labeling changes for Trasylol are based upon the recommendations of that advisory committee.

FDA announced on September 29, 2006, that Bayer informed the agency of an additional safety study on September 27, 2006. The preliminary results from that study suggest that in addition to serous kidney damage, Trasylol may increase the chance for death, congestive heart failure (a weakening of the heart), and strokes. The FDA review of this additional Trasylol safety information is continuing and it may result in other actions, including additional changes to the labeling. For additional information about Trasylol, see www.fda.gov/cder/drug/infopage/aprotinin/default.htm.