Qsymia is a combination of two FDA-approved drugs, phentermine, a stimulant and topiramate, which is used to treat epilepsy. The agency says after a year of treatment with Qysmia, patients lost 6.7% to 8.9% of their body weight.
Data show that patients who didn't lose at least three percent of their body weight by the twelfth week of treatment with Qsymia were unlikely have success with it. Patients must also reduce their calories and exercise.
Qsymia must not be used during pregnancy because it can increase the risk of cleft lip in the first trimester of pregnancy.
Vivus Inc., the company that makes the drug, will be required to conduct a long-term cardiovascular outcomes trial to assess the effect of Qsymia on the risk for major adverse cardiac events such as heart attack and stroke.
The most common side effects of Qsymia are tingling of hands and feet, dizziness, altered taste sensation, insomnia, constipation, and dry mouth.