FDA Approves Anti-Obesity Drug Belviq
Approval comes despite opposition from leading consumer health group
Friday, June 29, 2012
Another weapon in the battle against obesity.
The U.S. Food and Drug Administration (FDA) has approved Belviq (lorcaserin hydrochloride), as an addition to a reduced-calorie diet and exercise, for chronic weight management.
Public Citizen's Health Research Group blasted the move as “reckless."
"We expect that as with many of the other drugs, this one will be withdrawn from the market after the agency is forced to confront the many serious adverse health effects, such as heart valve damage, that will be reported," said the group's director, Dr. Sidney Wolfe.
Heart valve issues
Regarding that concern, FDA says heart valve function was assessed by echocardiography in nearly 8,000 patients in the Belviq development program. There was no statistically significant difference in the development of FDA-defined valve abnormalities between Belviq and placebo-treated patients.
Because preliminary data suggest that the number of serotonin 2B receptors may be increased in patients with congestive heart failure, Belviq should be used with caution in patients with this condition. Belviq has not been studied in patients with serious valvular heart disease.
The drug’s manufacturer will be required to conduct six post-marketing studies, including a long-term cardiovascular outcomes trial to assess the effect of Belviq on the risk for major adverse cardiac events such as heart attack and stroke.
Use driven by BMI
The drug is approved for use in adults with a body mass index (BMI) of 30 or greater (obese), or adults with a BMI of 27 or greater (overweight) and who have at least one weight-related condition such as high blood pressure (hypertension), type 2 diabetes, or high cholesterol (dyslipidemia).
BMI, which measures body fat based on an individual’s weight and height, is used to define the obesity and overweight categories. According to the Centers for Disease Control and Prevention, more than one-third of adults in the United States are obese.
Belviq works by activating the serotonin 2C receptor in the brain. Activation of this receptor may help a person eat less and feel full after eating smaller amounts of food.
Not for everyone
Belviq should not be used during pregnancy. Treatment with Belviq may cause serious side effects, including serotonin syndrome, particularly when taken with certain medicines that increase serotonin levels or activate serotonin receptors. These include, but are not limited to, drugs commonly used to treat depression and migraine. Belviq may also cause disturbances in attention or memory.
In 1997, the weight-loss drugs fenfluramine and dexfenfluramine were withdrawn from the market after evidence emerged that they caused heart valve damage. This effect is assumed to be related to activation of the serotonin 2B receptor on heart tissue. When used at the approved dose of 10 milligrams twice a day, Belviq does not appear to activate the serotonin 2B receptor.
The most common side effects of Belviq in non-diabetic patients are headache, dizziness, fatigue, nausea, dry mouth, and constipation, and in diabetic patients are low blood sugar (hypoglycemia), headache, back pain, cough, and fatigue.