Qnexa, what would have been the first new weight loss drug in a decade, was rejected in a narrow vote by the Food and Drug Administration. They reported concerns about the lack of data about the pill’s cardiovascular effects. The committee voted 10-6 against Qnexa, created by Vivus, Inc., which contains one of the active ingredients found in Fen-phen. Fen-phen was taken off the market because it was linked to heart damage.
Initial clinical studies found the drug to be effective and comparatively safe, although 18 percent of participants in the study dropped out due to side effects such as memory and concentration problems. These side effects are associated with the pill’s other active ingredient, the anticonvulsant topiramate. Qnexa meets the FDA’s standard for effectiveness, which is a five percent decrease in body weight in more than 35 percent of people taking the pill. Some concern has been expressed that there are other, potentially more severe, side effects that are being overlooked.
July 16th, 2010