For the second time in a month, the Food and Drug Administration (FDA) has approved a diet pill in a redoubled effort to target obesity in America. The approval of Qsymia, as well as Belviq before it, comes at the end of a 13-year dry spell in which the FDA did not approve any long-term drugs that sought to promote weight loss due to previous drugs’ safety concerns.
Qsymia is made up of the drugs phentermine and topimarate, which are used to promote short-term weight loss and to treat certain types of seizures in people with epilepsy, respectively.
Qsymia was due to be approved first by the FDA, but it was delayed so that the government agency could review the company’s plan to address side effects once the drug is sold, such as birth defects and elevated heart rate. Both Qsymia and Belviq were initially denied by the FDA in 2010 because of potential side effects. Belviq was associated with tumor growth in mice.
According to analysts, Qsymia’s delayed approval will have no bearing on its success. In fact, it was more successful than Belviq in trials. While participants in Belviq’s trials lost 5 percent of their body weight, Qsymia’s participants lost an average of 10 percent after a year. Qsymia’s participants lost an average of 22 pounds, and lowered their cholesterol and blood pressure levels.
Qsymia is meant to be used in collaboration with diet and exercise, and has been approved for obese patients and overweight patients with at least one weight-related condition, such as high blood pressure, high cholesterol, or type 2 diabetes.
The advisory panel voted 20 to 2 in favor of the drug, saying that its benefits outweighed the risks. The FDA said in a statement that women should avoid getting pregnant while on Qsymia, due to “increased risk of oral clefts,” like cleft palate or cleft lip. Women who can become pregnant will need to take a pregnancy test before starting the regiment.
The drug is also not recommended for people with glaucoma or hyperthyroidism or for people who have had a stroke or unstable heart disease in the past six months. Qsymia can only be sold and dispensed in specially certified drugstores.
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