In a stunning decision, an FDA advisory committee has reversed an earlier position, granting approval to a new prescription drug that will treat obesity.
The committee voted 20 to 2 in favor of weight loss pill Qnexa, which would be the first new prescription diet drug in 13 years. The New York Times reported that the same committee consisting of different members voted against the drug 10 to 6 in 2010, and the FDA did not approve it.
According to the Los Angeles Times, in a trial of 4,323 people, Qnexa showed an average loss of about 10 percent of total body weight in its first year, and many users saw their blood pressure improve.
But testing also found a slight increase in user’s heart rate, and a higher risk of birth defects, mainly cleft lip, in women who became pregnant while using Qnexa.
The drug’s manufacturer, Vivus Inc., will be required to conduct a study of Qnexa’s effects on the heart. The company has been given permission by the advisors to begin its study after the drug receives FDA approval, saving Vivus millions of dollars.
"I think they see the medical need," Vivus President Peter Tam said to My Fox Memphis.. "Right now there aren't any good treatments out there besides dieting and bariatric surgery, creating a huge gap."
Weight-loss drugs have seen a number of setbacks over the years. The Wall Street Journal reported that the fen-phen drug combination was pulled from U.S. market in 1997, after it was linked to leaks in heart valves. Meridia was taken off the shelves in 2010 after concerns of it causing heart attack and stroke.
The FDA generally accepts the recommendations of its advisory committees. Their decision is expected to come by April.