A new prescription weight-loss pill has been approved by the Food and Drug Administration (FDA), making it the first diet pill to hit the U.S. market in more than a decade. Arena Pharmaceuticals Belviq (lorcasserin) was deemed safe enough to get a nod by drug regulators, though the agency says studies showed only modest weight loss in clinical trials.
Belviq was approved for adults who are obese or overweight with at least one medical complication such as diabetes or high cholesterol. The drug should be used with a healthy diet and exercise.
The FDA first rejected Belviq in 2010 after panel members questioned animal studies that linked the drug to cancerous tumors. Arena resubmitted its application with additional data, and from that the FDA determined the risk for tumors in humans was minimal.
The race for drug companies to win approval for diet pills has been filled with obstacles at every turn. Safety studies are currently being conducted on Orexigen’s Contrave after the FDA said it did not have enough data to determine its safety risk. The agency in April also pushed back by three months its review of Vivus’ Qnexa to study potential heart risks and birth defect risks.
Later in April, the FDA told pharmaceutical companies who develop drugs for weight loss that they must determine heart risks with the drugs before seeking approval. The message conjured up memories of Fen-phen, which was pulled from the market 15 years ago after the drug was linked to heart-valve abnormalities.
The last weight-loss drug to be approved by the FDA was Roche Holding Xenical. That drug, which includes the active ingredient orlistat, is also sold over-the-counter under the brand name Alli. Orlistat carries unpleasant side effects, such as oily spotting on underwear or on clothing and gas with oily spotting. It has also been linked to severe liver injury.
In 2010, the FDA ordered the removal of the weight loss drug Meridia (sibutramine) because studies showed it increases the risk for serious cardiovascular events.