FDA Approves Treatment for Chronic Weight Management in Certain Pediatric Patients Aged 12 years and Older
The U.S. Food and Drug Administration has approved a supplemental indication for Qsymia (phentermine and topiramate extended-release capsules) for chronic weight management in pediatric patients aged 12 years and older who are obese, defined as a body mass index (BMI) of 95th percentile or greater when standardized for age and sex. Qsymia should be used as additional therapy to reduced-calorie diet and increased physical activity.
Qsymia can cause fetal harm if taken while pregnant, including an increased risk of oral clefts (cleft lip and cleft palate). It is recommended that patients who can become pregnant obtain a negative pregnancy test result before starting Qsymia treatment, perform monthly pregnancy testing, and use effective contraception while taking Qsymia.
Because of the increased risk for birth defects (cleft lip and cleft palate) with fetal exposure to Qsymia during pregnancy, Qsymia is only available through a restricted program called the Qsymia Risk Evaluation and Mitigation Strategy (REMS).
Further information on the Qsymia REMS is available at www.qsymiarems.com or at 1-888-998-4887.
Qsymia comes with additional warnings and precautions: Qsymia is associated with increased heart rate; Qsymia is associated with suicidal behavior and ideation, patients should monitor for mood changes, depression or suicidal thoughts and discontinue Qsymia if symptoms develop; Qsymia is associated with slowing of linear growth, growth should be monitored in adolescents taking Qsymia. Additionally, Qsymia is associated with acute myopia, secondary angle closure glaucoma, and visual problems; mood and sleep disorders; cognitive impairment; metabolic acidosis; and decrease in renal function.
The most common adverse reactions reported in the pediatric clinical trial included depression, dizziness, joint pain, fever, flu, and ankle sprain. The most common adverse reactions in adults are a pins-and-needles sensation, dizziness, an altered or impaired sense of taste, insomnia, constipation, and dry mouth.
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