FDA Approves New Weight Loss Drug

By Dr. Madelyn Fernstrom

In a long awaited move, the FDA approved a “new” weight loss drug, Qnexa, this past July 18. Renaming it Qsymia (cue-sim-ee-a), it’s actually a lower-dose combination of two drugs already on the market. Not for casual weight loss, or those “last ten pounds,” Qsymia is approved for use in adults who are obese (BMI of 30+), or adults who are overweight (BMI 27+) and have at least one major illness, like high blood pressure, sleep apnea, or diabetes. This drug, intended for use along with a reduced calorie diet and increased physical activity, is a combination of an appetite suppressant (phentermine) and an anti-seizure medicine (topiramate), which has weight loss as a “side effect” of epilepsy treatment.

While weight loss after one year of Qsymia — plus lifestyle changes — produced an average weight loss of 6 to 9 percent (an impressive outcome), many people lost a lot more, but some lost much less. There’s no guarantee of weight loss, and Qsymia is far from a “magic pill.” 

And, like other prescription medications, it has side-effects. Two major concerns are an increase in heart rate and a risk of birth defects (cleft lip/palate). Other side effects include insomnia, dry mouth, constipation, and tingling in the hands and feet. But the FDA decision supports the evidence that the benefits outweigh the risks.

Could it be a good power tool for your weight loss toolbox? Obesity is a medical illness of epidemic proportions. With two-thirds of the U.S. population overweight or obese, there will be a subgroup of people who DO need some medication to adjust their hunger and fullness thermostat. But there are many reasons people overeat that have nothing to do with biology, and they won’t be helped by any weight loss drug. A medication can support, but not replace, a reduced calorie diet. It makes the lifestyle effort more manageable (easier, but not easy!) for the long term. 

Qsymia will be available before the end of the year, but availability will be limited. To ensure careful and appropriate use, the company (Vivus) will restrict who can prescribe this medication, and the once-a-day pill would only be available through mail order. An experienced bariatric (weight-loss) physician or psychiatrist are two specialties to check with if you want a consultation.