Avandia's Heart Risk Higher Than Others in...(ministration said that GlaxoSmithKline h...),Health

Date:11/24/2008

ministration said that GlaxoSmithKline had agreed to add to the existing "black box" a new warning about the potential increased risk for heart attacks. Previously, the FDA had requested that GlaxoSmithKline and Takeda Pharmaceuticals, the maker of Actos, add a "black box" warning about the increased risk of heart failure associated with both drugs.

In July 2008, an FDA advisory panel said that drugs designed to control type 2 diabetes, including Avandia, should be subjected to more thorough safety reviews to ensure they don't raise the risk of heart problems. They recommended that all makers of these drugs conduct long-term cardiovascular trials, even if the drugs show no signs of heart problems in initial trials.

But Winkelmayer believes that neither Avandia nor Actos should be used as initial treatment. When they are used, they should be used with caution, especially with patients prone to heart problems, he said.

Dr. Eric J. Topol, director of the Scripps Translational Science Institute and chief academic officer at Scripps Health in La Jolla, Calif., also thinks both drugs should be used cautiously.

"The study reinforces the heart failure risk of rosiglitazone versus pioglitazone," Topol said. "Interestingly, it doesn't show any difference in heart attack, which is the one issue that has been so controversial. So it doesn't really change things that much."

Of the two drugs, Actos appears to have a more favorable track record, Topol added. "But the possibility of cardiovascular side effects, including heart failure and heart attack, can't be forgotten."

More information

For more information on diabetes, visit the U.S. National Institute of Diabetes and Digestive and Kidney Diseases.

SOURCES: Wolfgang C. Winkelmayer, M.D., Sc.D., assistant professor, medicine, Harvard Medical School, Bost
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