Critics of the Food and Drug Administration's approval of the new diet drug lorcaserin say the agency's track record on weight-loss pills ought to give consumers pause.
In a statement Wednesday, Sidney Wolfe, director of the health research group at Public Citizen, a consumer group, said that as with other diet drugs, he expects "this one will be withdrawn from the market after the agency is forced to confront the many serious adverse health effects, such as heart valve damage, that will be reported."
The FDA announced approval Wednesday of lorcaserin, to be marketed as Belviq (bel-veek), which acts on brain chemistry to create a feeling of fullness.
An FDA advisory panel discussed heart valve concerns. But in a statement, the FDA said there "was no statistically significant difference" in the development of valve abnormalities between lorcaserin and placebo-treated patients.
Scott Kahan, director of the STOP Obesity Alliance, says the FDA's decision to OK this medication shows that the agency believes the benefits of the drug outweigh the risks.
A quick look at other weight-loss drugs:
On the market now. Two prescription drugs are phentermine, which suppresses appetite; and orlistat (Xenical), which keeps some dietary fat from being absorbed. Orlistat is sold over-the-counter as Alli.
Pulled off the market. In 1997, two diet drugs were pulled from the market -- fenfluramine (part of the fen-phen combination) and dexfenfluramine (Redux) -- because of heart-valve concerns.
In 2010, Abbott Laboratories removed sibutramine (Meridia) because of concerns of an increased risk of heart attacks and strokes.
FDA reviewing now. By July 17, the FDA is expected to decide whether to approve Qnexa from Vivus. Used in combination with diet and exercise, patients lose about 10% of their weight on the proposed diet medication.
Seeking approval. In 2011, the FDA asked for a clinical trial on the cardiovascular safety of Contrave from Orexigen Therapeutics. Contrave combines two drugs now on the market and works to fight food cravings and improve the ability to control eating.
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