It promises to help patients lose five-to-ten percent of their weight (according to clinical trials) when combined with diet and exercise. But is this what America’s overweight patients really need?
Lorcaserin, the drug name for the prescription diet pill Belviq, was approved by the FDA today, making it the first weight loss drug to receive such approval since Orlistat (Alli) in 1999. This comes just weeks ahead of what is anticipated to be an FDA approval for Qnexa, another weight loss drug.
“In two clinical trials, Lorcaserin helped patients lose 5.8 percent of their body weight after a year. That’s about ten pounds for a 180 pound person. Big deal,” said our resident dietitian Mary Hartley, RD.
The drug works by controlling the appetite by making the brain think its fuller sooner. It’s fared well in clinical trials, and will have to undergo six more studies after its in market to ensure long-term cardiovascular health and to determine Belviq’s risk factor for heart attack and stroke. This makes the in-market patients unassuming guinea pigs, according to Hartley, and that isn’t right.
“The advisory committee decided that the benefits of the drug outweighed the risks heart value problems, but the drug manufacturer was made to conduct post-marketing studies to assess long-term cardiac events such as heart attack and stroke. That makes the patient a guinea pig. No thanks.” (more…)
UPDATE: 6/27/12: Lorcaserin, which will be sold as Belviq, received FDA approval today, making it the first diet pill the government agency has approved in more than a decade. Learn more about Lorcaserin.
In the midst of controversy over the weight loss drug Qnexa, a new drug has entered the arena of consideration after it was approved by an FDA advisory panel on Thursday.
The new drug, Lorcaserin, is made by Arena Pharmaceuticals and claims to control appetite through receptors in the brain. Experts tout its clinical trial results showed nearly half of participants lost up to five percent of their body weight.
The FDA committee approved the drug by a favorable vote of 18-4, and the FDA is slated to decide on its official approval by June 27.
Much like Qnexa, Lorcaserin was rejected in 2010 by the FDA advisory committee over numerous health concerns, including brain and breast tumors in rats during trials, as well as heart valve problems. However, these concerns dissipated after clinical trials showed these side effects did not appear on overweight and obese humans. The adverse effects experienced by those taking a 10 milligram dose of Lorcaserin included headache, dizziness, nausea, fatigue and dry mouth. (more…)
UPDATE: FDA Rejects Qnexa (7/16/2010)
The Huffington Post reported that on Monday, the Food and Drug Administration is expected to release the review of Vivus Inc.’s pill, Qnexa. The first of three new weight loss drugs to be assessed by the FDA, Qnexa showed promising results in clinical trials. Patients lost between 13 and 15 percent of their body weight, but many who began the trial dropped out due to side effects, which included memory and concentration problems. (more…)