Qsymia, First FDA-Approved Weight Loss Drug In 13 Years, Hits The Market Today

In the last year, in the scramble to treat America’s growing obesity problem (without, you know, telling Americans what to do or cutting ties with unhealthy lobbies), the FDA did something it hadn’t done in 13 years: Approved two new weight loss supplements, Belviq and Qsymia. Today, Qsymia is making its official debut. But it’s not a miracle pill. Here’s what you need to know.

Qsymia, which combines two approved weight loss drugs–phentermine and topiramate–that doctors have been prescribing together for years. If phentermine sounds familiar, it’s because it was the safer part of the notorious “fen-phen” drug cocktail that was yanked from the markets in the late 90s amid major health concerns. And topiramate, which is actually an anti-seizure medication, has been prescribed off-label by doctors for weight loss reasons, because it increases feelings of fullness and makes food taste less appetizing. When combined, the drug boosts energy and reduces appetite.

Unlike fen-phen, this drug won’t be prescribed as a mommy’s-little-helper, nor will it be for men and women who are only struggling with a little extra belly fat. Instead, it’s only going to be for “initial body mass index (BMI) of 30 or greater (obese),” or for those who are overweight, and have “at least one weight-related comorbidity, such as hypertension, type 2 diabetes mellitus or high cholesterol (dyslipidemia).”

Qysmia will, at least at first, only be available from certified pharmacies–which means it’s unlikely to be at your corner drugstore, and you’ll probably have to order it online if you and your doctor do decide it’s right for you.

But this drug isn’t without risk. According to Vivus, the maker of the drug, Qsymia can cause serious fetal harm. From the press release:

Females of reproductive potential should have a negative pregnancy test before treatment and monthly thereafter and use effective contraception consistently during Qsymia therapy. If a patient becomes pregnant while taking Qsymia, treatment should be discontinued immediately, and the patient should be informed of the potential hazard to the fetus. The drug also has potentially serious side effects. From the drug’s website: Qsymia may affect how you think and is associated with difficulty with attention and concentration, memory and word-finding. Therefore, use caution when operating hazardous machinery, including automobiles.

Of course, obesity itself is not without risk and, according to new numbers out today, America needs to do something fasts. Diabetes, high blood pressure, cholesterol, joint injury and pain, and heart disease are all real and serious problems associated with excess weight. But simply eating too much is only one of many factors that lead to obesity–and that’s all Qysmia and other weight loss drugs treat.

For the extremely obese, a drug like Qsymia could be complimentary to healthy weight loss. A reduced appetite and increased energy may help them get their weight to a point where other necessary lifestyle changes–like exercising or eating different, more nutritious, less processed foods–are possible. However, that’s not exactly how the drug is being marketed. There are just a few lines on the website which include anything about further measures, like this one: