The FDA recently approved a new weight loss drug, Belviq. It’s the first weight loss drug to gain approval since 1999 (Orlistat, also known as Xenical or Alli). However, the FDA is anticipating another weight loss drug (Qnexa) to be approved in the weeks ahead.
Lorcaserin works to control appetite. It makes the brain think the stomach is fuller, sooner. The FDA approved Belviq as “an addition to a reduced-calorie diet and exercise.”
Not everyone is thrilled with the new addition to the market. According Mary Hartley, RD for DietsinReview.com, “In two clinical trials, lorcaserin helped patients lose 5.8 percent of their body weight after a year. That’s about 10 pounds for a 180-pound person. Big deal.”
Although the drug did well in clinical trials, DietsinReview.com notes it will have to undergo six more studies after it is on the market. The studies include a long-term cardiovascular outcomes trial to assess the effect of Belviq on the risk for heart attack and stroke.
Hartley goes on to say, “The advisory committee decided that the benefits of the drug outweighed the risks, but the drug manufacturer was made to conduct post-marketing studies to assess long-term cardiac events such as heart attack and stroke. That makes the patient a guinea pig. No thanks.”
Locaserin was rejected by the FDA two years ago over concerns for its effect on heart valves.
Some health professionals think the drug is a step in the right direction to help address the obesity problem in the United States (although there is no substitute for proper diet, nutrition and lifestyle modification).
"Lorcaserin is just another sad attempt by the FDA to thwart the obesity epidemic,” says pharmacist Dr. Sarah G. Khan. “From studies like the Diabetes Prevention Program – where patients were given metformin, placebo or put in an intensive coaching program with education and given nutrition and exercise – we know that lifestyle modifications provide the most success in long-term weight loss and maintenance. The FDA's initial rejection of both Qnexa and Belviq shows that they had the right idea the first time. Drugs are not going to solve this problem. We know what will -- now we need a plan to execute it," notes Khan.
The FDA states that Belviq 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.
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