The FDA approved a new weight loss drug, Belviq or lorcaserin generically, on June 27, 2012. Belviq is manufactured by Arena Pharmaceuticals and is the first drug approved by the Food and Drug Administration in 13 years for weight loss. It approved Belviq as an “addition to reduced-calorie diet and exercise, for chronic weight management”.
Belviq was approved for obese people (BMI of 30 and over) and overweight people (BMI of 27 to 30) with other disease such as diabetes, high cholesterol, or high blood pressure. It was recommended to discontinue its use in patients that have not lost 5% body weight after 12 weeks of treatment.
Belviq activates serotonin receptors in the brain to help decrease appetite and feel fuller. Based on this mechanism, it may also reduce food cravings. Three studies were conducted that included 8000 patients to evaluate safety and efficacy. Treatment with Belviq showed an average weight loss range from 3 to 3.7% body weight. 47% of diabetics lost at least 5% of their body weight with improvement in blood sugar. Heart function was evaluated by echocardiogram in these 8000 patients, and no valve or heart function changes were noted. However, the FDA still cautions about use with patients who have congestive heart failure or severe cardiac valve disease.
Side effects include headache, dizziness, fatigue, nausea, dry mouth, and constipation. Hypoglycemia (low blood sugar) may be seen in diabetics. It can cause memory and attention problems. Caution should be used in patients on other medications that affect serotonin levels.
Arena Pharmaceuticals will be required to perform 6 additional studies as the drug comes on the market to continue looking at safety. It is expected to become available in pharmacies in 4-6 months depending on DEA processing, manufacturing, and labeling.
Belviq gives weight loss doctors another tool to provide a comprehensive approach for lasting weight loss. It is not going to be a magic pill, but it may provide another approach to control appetite and food cravings that when combined with proper nutrition and exercise, may be successful in achieving lasting weight loss.
The second post on new weight loss drugs will discuss the most recently approved medication – Qnexa/Qsymia that obtained official FDA approval yesterday.