WASHINGTON — The Food and Drug Administration has approved marketing of the weight-loss drug lorcaserin, the first prescription anti-obesity medication to win the FDA’s blessing since the agency approved orlistat in 1999. WASHINGTON — The Food and Drug Administration has
WASHINGTON — The Food and Drug Administration has approved marketing of the weight-loss drug lorcaserin, the first prescription anti-obesity medication to win the FDA’s blessing since the agency approved orlistat in 1999.
Once it is cleared by the Drug Enforcement Administration, the drug will be marketed in the United States under the commercial name Belviq.
The medication won marketing approval as a drug for “chronic weight management in adult patients” with a body mass index greater than 30, or for those with a BMI of 27 or above with a weight-related condition such as high blood pressure, elevated cholesterol or Type 2 diabetes.
The FDA’s approval came with a significant warning to consumers likely to flock to a medication that could help boost their weight loss: The safety and effectiveness of Belviq when used alongside other diet medications has not been established. Nor, the FDA said, has the effect of Belviq on the long-term risk of having, or dying from, a heart attack or stroke.
The approval followed a lengthy review by an agency under pressure to help Americans lose weight but also to screen out drugs that could prove dangerous once embraced by a large number of patients.
Just over 1 in 3 adult Americans is considered obese, and an additional 36 percent are overweight, prompting widespread concern that Type 2 diabetes, heart disease and certain cancers linked to obesity will overwhelm the U.S. health care system. Already, obesity-related disease is estimated to account for $147 billion in annual health care costs.
Belviq, made by San Diego-based Arena Pharmaceuticals, is one of four weight-loss drugs the FDA has anguished over in recent years. Safety concerns have prompted the agency to order the makers of two other candidate drugs to conduct and comb through additional research. A third drug was withdrawn after it was linked to an elevated suicide risk.
In the 28 months since the makers of Belviq submitted the drug for FDA consideration, the agency also demanded the withdrawal of Meridia after studies showed it increased the risk of heart attack and stroke. That left only two FDA-approved weight-loss drugs on the market: orlistat and phentermine.
The result has been — to the growing frustration of many obesity experts — almost no pharmaceutical aid for a steadily growing population of Americans desperate for help in shedding pounds.
Belviq offers would-be dieters modest benefits. One clinical trial found two-thirds of patients on the drug lost 5 percent of their body weight, while one-third lost at least 10 percent, after one year of taking the drug as a supplement to diet and exercise. Subjects’ average weight loss was 17 to 18 pounds.
Still, even this kind of modest weight loss can help lower a patient’s blood pressure, improve blood cholesterol measures and hold off or delay the onset of Type 2 diabetes, experts said.
