Prescription Drug to Aid Weight Loss Wins F.D.A. Backing
The first new prescription diet pill in 13 years won approval from the Food and Drug Administration on Wednesday, providing a new option for the roughly one-third of American adults considered obese.
In clinical trials, those who took the drug lost an average of about 6 percent of their weight after a year, meaning a person weighing 220 pounds — the average weight of those in the trials — would weigh 207 pounds after a year. The patients in the trial who got a placebo lost about 2 to 3 percent of their weight.
The main safety concern about Belviq is that it works somewhat similarly to fenfluramine, a drug that was part of the popular fen-phen diet pill combination. It and a similar drug called dexfenfluramine were withdrawn from the market in 1997 after they were found to damage heart valves.
The F.D.A. said in a news release Wednesday that it was satisfied that Belviq was different enough from fenfluramine that it would not cause such problems. However, Arena committed to conducting six studies after (emphasis mine) the drug reached the market, including one to determine whether the drug increased the risk of heart attacks and strokes.