FDA Expert Panel Vote Shows Concern Over Obesity Treatment Safety: Qnexa

On Thursday, the FDA panel of health experts voted 10 to 6 against Qnexa, Vivus’s new treatment for obesity. Reasons for the vote represented a number of safety concerns including memory laps, suicidal thoughts, heart palpitations and potential birth defects. The Food and Drug Administration will consider the panel’s decision before deciding on Qnexa as a treatment before the October 28 deadline.

Representatives from Vivus were disappointed with the panel vote. Obesity rates have reached nearly 35 percent in the United States populace and Qnexa was the first prescription treatment for obesity in the past ten years. Clinical trials have proven the drug is capable of reducing weight 10 percent. Kenneth Burman from the Washington Hospital Center chaired the panel. He believes the severity of the side effects must be considered against the success of the drug for reducing weight.

The decision of the FDA panel will cause future concerns for prescription drug treatment of obesity. Arena Pharmaceuticals and Orexigen Therapeutics are scheduled for panel review of their treatments in the near future. Several panelists were willing to change to a yes vote had Vivus extended the follow-up evaluation of drug effects for longer than one year. The market for obesity drug treatment has suffered safety concerns for decades.