December isn’t even half-way over, but it has already been a busy month for the FDA in terms of evaluating weight-loss methods that could help millions of overweight and obese Americans.
The first method considered by an FDA advisory committee was Allergan’s Lap Band. This form of bariatric surgery, which involves placing an inflatable ring around part of the patient’s stomach to reduce food intake, is already approved for those with a body mass index (BMI) of at least 40, as well as those with a BMI of 35 and an obesity-related health condition. However, Allergan has argued that it should be marketed to those with a lower BMI: 35, or 30 with a weight-related health condition.
The panel overwhelmingly agreed, 8-2, that the Lap Band could help millions more overweight people by lowering the BMI prerequisite.
Also scrutinized by an advisory committee recently was Contrave, a weight-loss drug by Orexigen combining the anti-addiction drug naltrexone with the antidepressant bupropion. The FDA recently rejected two other weight-loss pills due to safety concerns, and Contrave still has some scientists worried about its effects on the heart.
Although the average difference in weight loss between Contrave and a placebo fell a bit short of the FDA’s standard 5%, the panel still recommended approval with a 13-7 vote. They also recommended further heart-risk studies. Contrave would be the first prescription weight-loss pill approved by the FDA in a decade.
Decisions by the FDA on both products are expected in early 2011. The agency isn’t obligated to adhere to the recommendations of advisory panels, but it’s not uncommon.
Would you consider either the Lap Band or Contrave if they are approved? Why or why not? Let us know by leaving a comment below.
Find a Doctor
Find a NewBeauty "Top Beauty Doctor" Near you