Consumer Drug Report
FDA advisory panel suggests heart studies for obesity drugs

On Wednesday, a Food and Drug Administration advisory panel began a two day meeting to weigh whether the agency should tighten approval guidelines on obesity drugs.

The FDA Endocrinologic and Metabolic Drugs Advisory Committee voted 17-6 that cardiovascular risk, as it relates to obesity drugs, needs to be studied, even if no evidence of risk appears in early clinical trials.

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

Since the Fen Phen fallout of 1997, only one obesity drug, Xenical, has been approved. Now, three California-based companies are competing for FDA approval.

One drug, Qnexa, was endorsed last month after being rejected in 2010 when an FDA panel said the drug's risks of heart problems and birth defects outweighed its weight-loss benefits. Arena Pharmaceuticals Inc.’s lorcaserin is set for evaluation in May, and Orexigen Therapeutics Inc.’s Contrave is required to conduct additional studies after being rejected in September.

Currently, companies must conduct at least a year long study of overweight people to determine whether they lose weight compared to patients in a placebo group. The study must also determine whether there is any link to changes in heart rate, blood pressure, and other side effects.

The FDA is considering whether to adopt approval guidelines similar to those placed on  diabetes medications in 2008. Makers of those drugs must conduct studies for two years and prove there is no risk of heart attack risks or other heart-related problems.

"One could argue that obesity is prediabetes," says Dr Lamont Weide of the University of Missouri in Kansas City.The Centers for Disease Control and Prevention estimates that more than 78 million U.S. adults are obese. With that in mind, patient representative Lynn McAfee of North Port, FL, voted in favor of new obesity drug regulations because the potential for harm could be "catastrophic."

Dr Richard Bergman of North Port, FL, also voted in favor of the regulations, but says, “I think that cardiovascular risk is only one of many other risks that may come to light as new drugs are developed. … Focusing on cardiovascular risk at the expense of others is not good."

The FDA is not required to go along with the panel’s decision.


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