The U.S. Food and Drug Administration (FDA) has approved Qsymia (phentermine and topiramate extended-release) as an addition to a reduced-calorie diet and exercise for chronic weight management. The drug 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) who have at least one weight-related condition such as high blood pressure, type 2 diabetes, or high cholesterol. Qsymia must not be used during pregnancy because of increased risk of oral clefts (cleft lip with or without cleft palate) during the first trimester due to the topiramate component of the drug. Qsymia is also not for use in patients with glaucoma or hyperthyroidism because it can increase heart rate. The approval comes on the heels of the FDA's approval of Belviq (locaserin hydrochloride) last month as a weight-management aid. Qsymia, known as Qnexa during its development, is marketed by Vivus Inc.
Read more about Qsymia's journey to approval in Psychiatric News, here, here, and here.
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