FDA Panel Okays Shiny New Weight-Loss Drug, Despite Concerns
LatestAn FDA panel has recommended the approval of new weight-loss drug Contrave, even though it may actually raise blood pressure.
According to MedPage Today, the advisory panel voted 13-7 yesterday to approve the drug, despite some questions on both its efficacy and its safety. First of all, Contrave doesn’t help patients lose that much weight. Over 30% of study subjects lost 5% of their body weight on it, which is one of the FDA’s standards for weight-loss drugs. But after a year, Contrave patients lost just 4.2% more than control patients, failing to meet another FDA standard — a 5% difference between drug group and control. And for control patients who were also enrolled in a “lifestyle modification program,” the difference was even tinier, meaning that Contrave may not be that much more effective than the old standby: diet and exercise.