WEDNESDAY, July 18, 2012 (HealthDay News) -- Qsymia (phentermine and topiramate extended-release) has been approved by the U.S. Food and Drug Administration, making it the second weight-loss drug to be given the agency's green light in less than a month.
In June, the agency sanctioned Belviq, the FDA's first diet drug approval in some 13 years.
Qsymia is approved for adults with a body mass index (BMI) of 30 or greater (obese) or a BMI of 27 or higher with a weight-related condition such as high cholesterol, high blood pressure, or type 2 diabetes. BMI is a measurement of a person's body fat, based on their height and weight.
Qsymia should never be used by pregnant women, the FDA warned, since it can cause birth defects including cleft lip and cleft palate. Women of childbearing age should have a pregnancy test before starting the drug, the agency said.
People who do not lose at least three percent of body weight after 12 weeks of treatment are unlikely to benefit and should discontinue use, the FDA said.
Qsymia's safety and effectiveness were evaluated in clinical trials involving 3,700 obese and overweight people. The most common side effects reported included tingling of the hands and feet, dizziness, altered taste, insomnia, constipation and dry mouth.
Drug maker Vivus Inc., based in Mountain View, Calif., is required to conduct post-approval studies to evaluate Qsymia's risks for major cardiac problems, such as heart attack and stroke, the FDA said.
The FDA has more about this approval.