FDA Clears First Weight-Loss Pill in 13 Years
WEDNESDAY, June 27 -- The Arena Pharmaceuticals drug Belviq (lorcaserin hydrochloride) has been approved by the U.S. Food and Drug Administration, the first approval of an anti-obesity medication in 13 years.
The drug is sanctioned for people aged 18 and older with a body-mass index (BMI) of 30 or higher, or adults with a BMI of at least 27 who also have a weight-related condition, such as type 2 diabetes or high blood pressure, the agency said in a news release. BMI is a measure of a person's body fat in relation to their height and weight.
Belviq is designed to activate a brain receptor that helps people feel full after eating less. The drug was clinically evaluated in a study of nearly 8,000 overweight and obese people, the FDA said.
The drug's label suggests it be discontinued if a person fails to lose at least 5 percent of their body weight after 12 weeks of treatment, the agency said.
Arena, based in Switzerland, will be required to conduct six post-marketing studies to measure users' risks of heart attack, stroke and other cardiovascular problems, the FDA said.
Common clinical side effects of Belviq included headache, dizziness, fatigue, nausea, dry mouth and constipation. People with diabetes also are at greater risk of low blood sugar (hypoglycemia), the agency said.
The U.S. Centers for Disease Control and Prevention has more about overweight and obesity.
Posted: June 2012