New Weight Loss Pill – Qsymia – Now Available in U.S.

“These are flying off the shelves!”

On July 17, 2012, the U.S. Food and Drug Administration approved the combination of topiramate and phentermine for weight loss and management.  They’ll be marketed in the U.S. as Qsymia.

The drugs individually had been approved by the FDA years ago for other purposes, so we already know a lot about them.  If memory serves me, phentermine alone is FDA-approved for weight loss, but only for “several weeks,” which many physicians interpret as up to 12.

The press releases from the FDA and Vivus, Inc., don’t say how long the combo drug can be used.  I’m guessing up to one year since that’s how long the clinical trials lasted.  Any longer than that, you’re on your own.

Who Can Take Qsymia?

Obese adults with a body mass index 30 or higher, or overweight adults with BMI 27 or higher if they have one or more weight-related condition such as high blood pressure, type 2 diabetes, or high cholesterol.

You Should NOT Take Qsymia If You Have or Are:

  • Pregnant
  • Glaucoma
  • Overactive thyroid
  • Recent stroke
  • Recent unstable heart disease

If I Take the Pill, Do I Still Have to Exercise and Watch My Calories?


What’s the Dose?

Phentermine 7.5 mg and topiramate 46 mg daily.  A double strength pill (15 + 92 mg) is available for select patients.

Final Thoughts

Lorcaserin (Belviq) is a weight loss drug approved by the FDA within the last month.  These are the first new weight loss drugs on the U.S. market since 1999.

Abbott voluntarily withdrew Meridia (sibutramine) from the U.S. market in 2010 due to concern about it causing heart attacks and strokes.

In 2008, the European Medicines Agency withdrew prescription-writing for the weight-loss drug rimonabant, citing concern about psychiatric side effects.

Between 1997 and 2007, five weight-loss drugs were removed from various markets around the world due to safety or effectiveness considerations: phenylpropanolamine HCl, dexfenfluramine HCl (e.g., Redux), fenfluramine HCl (Pondimin), diethylpropion HCl (Tenuate), and phentermine HCl (e.g., Ionamin).

It’s unknown whether weight-loss drug therapy reduces the morbidity and mortality of obesity over the long run.

I’ll wait at least two or three years before giving these new drugs to my patients—I’ve seen too many drugs withdrawn from the market because of adverse effects showing up years after drug approval.

Without permanent changes in lifestyle, lost weight is likely to return after you stop taking any weight-loss pill.

Clearly, drugs are no panacea.

Steve Parker, M.D.

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