Obesity drugs need heart studies, U.S. advisers say

Clinical Trials Sunday, April 8th, 2012

Reuters.com: By Anna Yukhananov, SILVER SPRING, Maryland | Thu Mar 29, 2012.

(Reuters) – Heart safety studies should be required for new obesity drugs, U.S. drug advisers said on Thursday, possibly adding a new hurdle to the drugs’ approval.

An advisory panel to the U.S. Food and Drug Administration voted 17-6 that regulators should make companies conduct heart impact studies in order to sell their drugs in the United States, even if clinical trials do not initially show evidence of increased heart risk.

“Anti-obesity drugs have a bad track record of cardiovascular risk,” said Dr. Marvin Konstam, a professor at Tufts University School of Medicine and panel member. Read More

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