FDA Advisory Panel Recommends NOT Approving Qnexa

In an update, the FDA advisory panel reviewing the weight-loss drug Qnexa has voted to reject it.

The final FDA decision will not be issued until October, but the advisory panel’s decision is usually key to their decision.

In a 10-6 vote, a Food and Drug Administration advisory panel said they were concerned that Qnexa was too experimental. […] Approving the drug would be “a huge public health experiment,” said panelist Elaine Morrato of University of Colorado.

[…] Vivus is seeking FDA’s green light to sell Qnexa to adults to use once a day to slim down in it hopes could become the first prescription diet drug in a decade. The company told advisers its pill offers a safe option for shedding pounds and improving their health.

There is little doubt the drug works, but panelists said potential side effects such as depression, memory loss, increased heart rate and birth defects are a worry.

Panelists were also concerned since patients may take Qnexa for years but Vivus only studied it for about 12 months.

Qnexa is a combination of phentermine and topiramate aka Topamax.  I also posted about the drug a few days ago.

11 thoughts on “FDA Advisory Panel Recommends NOT Approving Qnexa

  1. Wow. They’re actually taking the safety of fat people into consideration? That doesn’t happen too often.

    Still, it’s a piece of good news and I’ll take that happily for what it’s worth.

  2. Yeah, topomax is not a minor drug; my husband takes it for his migraines; and it is well worth it for him. However, one pet name for it is dopomax because it makes you feel stupid.

    Depression, birth defects, memory loss—how could any of the panel have voted for this drug? Jeebers

    • If I had daily migraines or epilepsy and Topamax controlled them, I’d probably love it.

      But as a weight-loss drug? When I already have recurrent clinical depression? Um…not so much, no.

  3. What a great way to guarantee that fat people conform to the “fat people are stupid” stereotype, by giving us a weight loss drug that diminishes mental function! Whoo-ee!!!

    • Yea….when I read about the side effects I immediately thought of the fat people in the movie Wall-E. Most of them were clueless and living in a fog–unaware of their reality–and came off as kind of dumb. Although, once the veil was lifted, they immediately snapped out of it. I’m not so sure that bounce back will be as immediate once you come off this drug.

  4. Topamax is one of those drugs that is a godsend for a few people who take it, and a nightmare for everyone else. That doesn’t mean it should be banned, but using it as part of a diet pill? With phentermine? Oh gods no.

  5. If the evidence (self reports) on some pro-anorexic blogs is any indication, some women already take Topamax for weight loss. They simply lie to their doctors about migraine symptoms. The pressure in this culture (especially on young women) to become thin goes beyond anything I would have once accepted as science fiction.

  6. I take topamax for migraines and the first thing my neurologist said was that it might help me lose weight. Ummm, no, I don’t care about the weight, I care about getting rid of the migraines, thank you very much. And the amount I take hasn’t had an effect on my weight, so I think it’s very much a YMMV thing.
    Adding phentermine to topamax? WTF are they thinking? Wasn’t the debacle with phen-fen a big enough clue-by-four for them? I really, really hope the FDA doesn’t approve this drug over the recommendation against approval (but there’s plenty of time between now and October for the drug company to lobby for approval (and you know they don’t care about health, it’s the almighty dollar they’re after).

    • Once a doctor wanted to prescribe some medication for either depression or bi-polar (not sure which or which drug, this was quite some time ago) and the only side effect he felt was worth mentioning was that it might cause weight loss. Direct quote… “but we’ll just view that as an extra bonus, or at least nothing we have to worry about!”.

      le sigh

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