The much anticipated diet drug Qsymia is officially on the market. Qsymia, made by Vivus, is one of two new weight loss drugs approved earlier this year by the Food and Drug Administration (FDA), becoming the first diet pills cleared by the FDA in more than 13 years.
Unlike other drugs for weight loss, Qsymia, and new rival Belviq, are considered “life-long” treatments for obesity and should be used along with a diet and exercise program. Though both help users lose weight, they work in entirely different ways.
Belviq contains the active ingredient lorcaserin, which works by activating a part of the brain that controls hunger. Qsymia, on the other hand, is a combination of two drugs that individually have been on the market for years – phentermine, an appetite suppressant, and topiramate, used to treat epilepsy and migraines.
Both drugs are only available by prescription and are eligible for people 18 years or older with a body mass index (BMI) of 30 or greater or a BMI of 27 or greater with at least one other weight-related condition. People with BMIs of 27 or greater are considered overweight, and those with a BMI of 30 or more are considered obese.
Unlike other weight loss drugs, Qsymia is approved for women of childbearing age, but only if while taking it they use effective birth control consistently and have a negative pregnancy test before and during use. Qsymia raised concerns during FDA reviews because of the potential risk for birth defects associated with its active ingredient topiramate.
The FDA has been cautious about approving new diet drugs because of the potential for serious side effects. In 1997, two diet drugs were removed from the market because of concerns about damage to the heart valve. In 2010, the drug sibutramine (Meridia) was pulled because of concerns about the increased risk of cardiovascular events.
The makers of Belviq and Qsymia will be required to perform long-term trials to examine the risk for heart attacks and strokes.