Food and Drug Administration today approved the first prescription weight-loss medication in 13 years. But the agency placed restrictions on the use of the medication and said its manufacturer must conduct additional tests to measure the risk of possible side effects.
Lorcaserin hydrochloride, which is marketed as Belviq by Arena Pharmaceuticals, should be prescribed only for obese adults or overweight adults who have at least one weight-related disease, FDA says. The agency also said pregnant patients shouldn’t take Belviq.
FDA rejected Belviq 2 years ago because of evidence that the medication could cause cancerous tumors and heart-valve damage. But in May 2012, an FDA advisory panel recommended that FDA approve the medication.
The new tests that Arena conducted and the results of which Arena submitted to FDA didn’t suggest that the risk for those side effects have been reduced. But as part of the approval of the medication, FDA ordered Arena to conduct new studies, including a long-term evaluation of the cardiovascular risks that might be associated with Belviq.
As we reported on June 26, health experts worry that the potential risks of Belviq outweigh any potential benefits. But FDA today said obesity contributes increasingly to other health problems, such as diabetes and high blood pressure. And the agency stressed that Belviq should be used “in combination with a healthy diet and lifestyle.”
FDA is scheduled to review a second weight-loss drug, Qsymia, on July 17. Qsymia also was rejected by FDA 2 years ago.
– K. Fanuko