The committee voted, 9 to 5, agaianst recommending approval because the risks of the drugs outweighed the potential benefit of modest weight loss. Studies in animals showed the drug was associated with tumors, although an increased cancer risk has not been seen in human clinical trials.
Lorcaserin, made by Arena Pharmaceuticals Inc., is similar to Meridia, an obesity medication already on the market that works by suppressing appetite. On Wednesday, however, the FDA Endocrinologic & Metabolic Drugs Advisory Committee ruled that Meridia should either be taken off the market or undergo changes to limit its availability to only people who have no history or risk of cardiovascular disease. Previous studies show the drug increases the risk of heart attack and stroke among users who have cardiovascular disease. The medication has already been taken off the market in Europe.
Lorcaserin (the brand name is Lorqess) does not seem to carry those same risks, according to studies. However, the advisory committee was apparently unimpressed with the amount of weight loss experienced by users in clinical trials.
In a close vote, the FDA committee recommended in July against approval of the obesity drug Qnexa because of the possibility of psychiatric side effects and other potential safety concerns. Qnexa, made by Vivus, contains the amphetamine phentermine and the anticonvulsant topiramate and works by suppressing hunger.
The FDA will issue its decisions on Qnexa, Meridia and lorcaserin alter this year.
There is yet one more chance for a new obesity drug to hit the market. The advisory committee will meet in December to vote on Contrave. The product also combines two existing medications: the antidepressant bupropion and the addiction drug naltrexone. It works by helping to curb appetite and food cravings.
Besides Meridia, the only other prescription obesity drug on the market is Xenical, which is also sold over-the-counter as Alli.