FDA Advisory Committee Favors Approval of New Prescription Weight-Loss Medication

A Food and Drug Administration (FDA) advisory committee recently recommended approval of the weight-loss drug Qnexa. Qnexa is a combination of two existing drugs. It is composed of the appetite suppressant phentermine, which was part of the fen-phen combination, and the anti-seizure medication topiramate, more commonly known by its brand name Topomax. Pre-approval studies show that using Qnexa led to an average weight loss of ten percent of body weight after one year. In addition, positive effects on blood pressure, blood sugar, and some blood lipids were also noted. However, the studies also showed that Qnexa increased heart rate which is a danger signal that the drug might actually be a dangerous drug if it increases the risk of heart attack.

The committee voted 20 to 2 that the benefits of Qnexa more than offset the potential risks of heart problems and birth defects. This overwhelmingly positive vote came as a surprise to many due to the fact that the same advisory committee voted 10 to 6 against Qnexa in 2010. The FDA is expected to issue a decision regarding approval or non-approval of Qnexa by April 17th. If Qnexa secures FDA approval, Qnexa would be the first new prescription weight-loss medication in over a decade.

If you or someone you know has been harmed while taking a weight loss drug, contact the attorneys at Abraham, Watkins, Nichols, Agosto, Aziz & Stogner by calling (713) 222-7211 or 713-222-7211.