ATLANTA (CBS ATLANTA) -
Advisers to government health regulators on Thursday recommended that they approve sales of what would be the first new prescription weight-loss drug in the U.S. in more than a decade, despite concerns over cardiac risks.
A panel of expert advisers to the Food and Drug Administration voted 18-4 to recommend approval of lorcaserin, developed by Arena Pharmaceuticals Inc.
They concluded that its benefits "outweigh the potential risks when used long term" in overweight and obese people. One panel member abstained from voting.
Lorcaserin is one of three experimental weight-loss drugs whose developers have been trying for a second time to win approval, after the FDA shot them all down in 2010 or early 2011 because of serious potential side effects.
The panel's vote Thursday comes two days after federal health regulators gave a surprisingly favorable assessment of lorcaserin, the same diet pill the agency turned down in 2010.
At the time, scientists raised concerns about health issues including tumors that developed in laboratory animals tested with the drug.
In the interim, the San Diego company again applied for approval, submitting additional data in hopes of swaying the agency to a favorable decision.
A review of all the research studies by FDA staff, posted online Tuesday, stated that new analysis Arena submitted suggests there's only a "negligible risk" of tumors in people taking the drug.
However, questions remain about it possibly increasing risk of high blood pressure in diabetics or damaging heart valves, a life-threatening side effect that has been an issue with some earlier weight-loss pills.
The FDA is not bound to follow the advice of its advisory panels, but generally does so.
