Two weight-loss drugs are getting FDA scrutiny this week: Abbott Laboratories’ Meridia is on the FDA chopping block, while Arena Pharmaceuticals’ new drug lorcaserin is up for review. Meridida has come under heightened scrutiny after a study demonstrated it raised the risk of heart attack and stroke by 16 percent in patients with heart disease, but only produced modest weight loss results. In a split vote yesterday, half of the members of an FDA advisory panel recommended that Meridida remain on the market as long as a boxed warning label is added and its use is restricted so that only specially trained doctors are allowed to prescribe it.
“Since the panel has evaluated all the risks and benefits, a 16 percent increase in heart attack or stroke versus a mere 4 percent weight loss may well warrant such a recommended restriction,” observes ACSH's Dr. Gilbert Ross.
An FDA advisory panel is also expected this afternoon to make a recommendation on lorcaserin, which uses fenfluramine to suppress appetite signals in the brain. Company study results indicate that patients who took lorcaserin twice daily for a year, on average lost 5.8 percent of their body weight.
“We encourage the FDA panel to not only take into account the drug’s potential risks, but also the dangers associated with obesity, because we are not doing an adequate job fighting the obesity epidemic,” says ACSH's Jeff Stier.