FDA Approves Qsymia for Weight Loss

“These are flying off the shelves!”

On July 17, 2012, the U.S. Food and Drug Administration approved the combination of phentermine and topiramate for weight loss and management.  They will be marketed in the U.S. as Qsymia.  Don’t ask me how to pronounce it.

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 up to 12 weeks.

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.

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?

Yes.

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I’ll wait at least two or three years before giving these new drugs to my patients—I’ve seen too many drugs withdrawn from the market because of adverse effects showing up years after drug approval.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

4 responses to “FDA Approves Qsymia for Weight Loss

  1. If I’m not mistaken, topiramate is Topamax. Many doctors call it “Dope-amax” because of one of its side effects – it makes you stupid.

    I was prescribed it for migraines. Even if it had helped, I would rather have a headache.

    Methinks finding obesity drugs that work on the brain is fraught with danger. I’m guessing the next practical drug will come from incretin studies. Anyone with a different guess?

  2. Yes, P Daddy. Topiramate is Topamax, at least in the U.S. I hadn’t heard about Dope-amax – that’s cute.
    How about a weight-loss drug related to leptin?

    -Steve

  3. My understanding of leptin is that the obese have plenty of it and that adding more doesn’t do anything – hence the concept of leptin resistance. I also understand that leptin administration is very helpful in weight maintenance after loss – the actual biggest problem. So, leptin anologs or whatever might be very helpful in stopping the yo-yo.

  4. Pingback: European Officials Decline Weight-Loss Drug Approved Last Year in U.S. | Advanced Mediterranean Life