The U.S. Food and Drug Administration announced on Wednesday that it had approved the use of the prescription drug Belviq to aid weight management efforts by adults. The drug is the first prescription weight-loss aid approved by the FDA since 1999.
The FDA had refused to approve the drug in 2010 when maker Arena Pharmaceuticals Inc. had first sought to put the drug on the market. The agency had been concerned about its overall safety and rate of success, according to WebMD.
How is Belviq approved to be used?
The FDA has approved Belviq for use by adults with a body mass index (BMI) of 30 or higher. This means that an adult must be considered to be obese in order to be prescribed the drug. Doctors may make an exception for overweight adults with a BMI of 27 or higher, if that person has at least one weight-related illness, such as type 2 diabetes or high blood pressure, according to the FDA's announcement.
Why did the FDA approve Belviq this time, rather than before?
Reuters reported that the FDA has been under pressure from health professionals and others to approve some of the weight-loss treatments that are being developed by pharmaceutical companies, in lieu of the fact that more than two-thirds of all Americans are now considered to be obese. Arena Pharmaceuticals' Belviq is the first, but there are at least two other companies, Vivus Inc. and Orexigen Therapeutics Inc., that have drugs that have been re-submitted for FDA approval.
Since being rejected for approval the first time around due to concerns that it increased a person's risk of developing certain cancers, the makers of Belviq have submitted further research to the FDA. That research concluded that although the drug appeared to raise the risk of cancer in rats, there had been no evidence that it did the same when used by humans.
How will the FDA monitor Belviq?
A MedPage Today/ABC News collaborative report indicated that despite the evidence that Arena produced to show that Belviq does not pose an increased risk of cancer, the FDA is still requesting additional data regarding the drug's impact on the human heart. The FDA has determined that the company that manufactures the drug must conduct six different postmarketing studies. At least one of those studies must be a long-term examination of the drug's effects on the cardiovascular system, and the company must also examine whether or not there is an increased risk of stroke due to use of Belviq.
How is Belviq actually supposed to work?
According to the New York Times, Belviq is supposed to be used in combination with exercise and a reduced-calorie diet, and is only meant to result in modest weight loss. The drug reportedly works by activating receptors in the brain, known as serotonin 2C, that make a person feel full. That feeling of fullness leads people to restrict their eating, and combined with exercise, works to help them lose a moderate amount of weight.
Vanessa Evans is a musician and freelance writer based in Michigan, with a lifelong interest in health and nutrition issues.
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- Arena Pharmaceuticals