"My enthusiasm is mixed based on the published efficacy of the combination and the clear concerns reflected in the advisory committee vote," said David J. Kroll, a professor of pharmaceutical sciences at North Carolina Central University.
Dr. Peter A. McCullough, a cardiologist serving as chief academic and scientific officer at St. John Providence Health System in Novi, Mich., said bupropion and naltrexone are "reasonably safe" individually, but together "pose a complicated issue" of potential drug interactions in obese patients taking other commonly used medications.
The diet drug landscape is littered with failure. In 1997, the FDA pulled the diet drug combination of phentermine and fenfluramine (Fen-phen) and a related drug dexfenfluramine (Redux) from the market because some patients developed leaky heart valves. The medical and pharmaceutical communities suffered another blow when reports of depression and suicide became the undoing of once-promising rimonabant (called Zimulti in the United States and Acomplia in Europe), which blocks appetite-stimulating cannabinoid receptors in the brain. In June 2007, its French manufacturer, Sanofi-Aventis, withdrew its FDA application.
In light of obesity's enormous toll on heart health, Dr. Carl J. Lavie, medical director of cardiac rehabilitation and prevention at the Ochsner Clinic Foundation and Hospital in New Orleans, said more effective therapies are needed. He said he thought the FDA panel "so far is leaning to the drug producing more benefit than harm. Time will tell whether the 13 or the 7 were correct."