FDA Approves New Weight Management Drug for Kids over 12

Recently, the FDA approved Qsymia for chronic weight management in pediatric patients over 12 years old. Qsymia is an extended-release pill composed of phentermine and topiramate. The drug’s intended use is for obese patients with a BMI over the top fifth percentile. This approval comes as an expansion of the July 2012 approval of Qsymia for weight management in adults.  

Pediatric obesity has become a health concern for many kids, parents, and pediatricians in the United States. According to the CDC, between 2017 and 2020, 19.7% of kids between the age of 2 and 19 had childhood obesity.  

Obesity prevalence rates differ based on race and socioeconomic status. Hispanic children had the highest rates of obesity while non-Hispanic Asian children had the lowest rates of pediatric obesity. The obesity incidence in Hispanic children is 6.5% greater than the national average and 9.6% higher than the rate of non-Hispanic White children.  

The CDC also found that, between 2011 and 2014, pediatric obesity rates are inversely proportional to the education level of the head of the household. Similarly, as the average household income increased, the rate of pediatric obesity decreased.  

A study published in the Journal of Experimental and Therapeutic Medicine did an in-depth analysis of pediatric obesity. While identifying pediatric obesity as a public health crisis, researchers highlighted potential causes, including diet, exercise, and genetics.  

The FDA announcement emphasized that Qsymia is not to be used as the only treatment for pediatric obesity. In cases where lifestyle changes were ineffective in weight management, Qsymia can be given to assist alongside a proper diet and exercise regimen. 

The efficacy of the drug was analyzed in a 56 week longitudinal study. During this study, 223 pediatric patients between the ages of 12 and 17 were given one of the following treatment options: Qsymia with a 7.5 mg/46 mg dose, Qsymia with a 15 mg/92 mg dose, or placebo. The treatment group for the 15 mg/92 mg dose Qsymia was twice as large as the other two experimental groups.  

Both groups taking the drug saw a reduction in their BMI, while the placebo group saw an increase in their BMI. The 15 mg/92 mg dose of Qsymia saw a BMI reduction of 7.1%, while the 7.5 mg/46 mg dose was 4.8%. 

Despite the benefits of Qsymia in weight management, there are some drawbacks and potential side effects. First, the drug has been associated with congenital disabilities if taken while pregnant. Additionally, it may also contribute to visual, behavioral, and heart rate changes.  

Pediatricians will have to weigh the potential outcomes of obesity with the drug’s possible side effects. Due to the potential side effects, “Qsymia is only available through a restricted program called the Qsymia Risk Evaluation and Mitigation Strategy (REMS),” said the FDA announcement. Drug use will likely be made on a case-by-case basis for patients.