July 15th, 2010
06:50 PM ET

FDA panel says 'no' to new diet drug

An FDA advisory panel voted Thursday to recommend the rejection of Qnexa, a new diet drug that is a combination of two older medications. The vote was 10-6, with members apparently most concerned about the rate of cognitive and psychiatric side effects.

The hard-to-pronounce medication – call it “Qui-nex’-uh” – was developed by the company Vivus, and is a combination of two more familiar drugs. One, phentermine, is an amphetamine that made up the "phen" half of Fen-Phen, the diet drug that was pulled from the market in 1997 after some users died of heart valve problems. An FDA review of Qnexa blamed "Fen" – fenfluramine – for the deaths.

The other component of Qnexa is topiramate, an anti-seizure medication that has been investigated for a range of other uses, including the treatment of alcoholism. This spring, Johnson and Johnson, which markets topiramate under the brand-name Topamax, was accused of going overboard in its enthusiasm, paying an $81 million fine to settle charges that it illegally marketed the drug for unapproved therapies.

Qnexa is part of a wave of new diet drugs. At least two others – lorcaserin and Contrave  – are scheduled to go before the FDA panel by the end of this year.

soundoff (156 Responses)
  1. Donna

    I was part of the study for this pill and i lost 52 lbs and 7 inches off my waist, I had no psychological side effects, as a matter of fact after the year long study i had never felt better. my blood pressure was back to normal which had skyrocketed when i quit smoking, my cholesterol went down to normal, my liver function improved. it also kept me from getting migrains.
    I think the FDA needs to re-look at this drug and look at all the possitive effects and make it by prescription only with the monitoring from their doctors. i was actually looking forward to this pill coming out so i could lose the rest of my weight.
    and for all of you who think it is that easy to just "lose weight by diet and excercise" some people dont have it as easy as you when it comes to losing weight. if it were that easy we would all be skinny.

    July 16, 2010 at 11:43 | Report abuse | Reply
    • Inkt1

      Simple-not easy. Simple is NEVER easy...

      July 16, 2010 at 11:54 | Report abuse |
    • Inkt1

      And, by the way–I'm sick and tired of people assuming by the way I talk about nutrition and fitness that I have it EASY. I grew up handicapped. A staph infection when I was an infant killed the vascular system in my hips so they never grew correctly. It also fused my lowermost vertebra to my pelvis contributing to my roto-scoliosis (the spine isn't just curved, it's twisted too) and fused a joint in my left thumb jacking up all the tendons all the way up my forearm. I had each hip reconstructed before I WAS OLD ENOUGH TO DRIVE and each hip replaced before I was 21 years old. Plenty of excuses for me to get a handicapped sticker, collect my disability check and sit on the damn couch. But those are all excuses. Our limits are not there to stop us. They are there to challenge us. It doesn't mean you do NOTHING or look for a quick fix. It means you dig deep into yourself and learn what you're made of. And I also quit smoking cold turkey–my blood pressure normalized after I started EATING RIGHT AND EXERCISING!!!!

      July 16, 2010 at 12:11 | Report abuse |
  2. Tanita

    Interesting how in countries where people are dying from hunger, no one has obesity or chemical imbalance problem.

    July 16, 2010 at 11:59 | Report abuse | Reply
  3. Pam

    I found that topiramate (taken for back pain) left me COMPLETELY paranoid, anxious and borderline suicidal for the 4 days I was on it (in 2004). I did lose my apetite because I was conviced the food was poisoned! Not a good drug for me & I suggest others use it with great caution.

    July 16, 2010 at 12:08 | Report abuse | Reply
  4. Kimmie

    I took Topamax for a year for the treatment of migraines. I would recommend it for seizures and migraines, WITH CAUTION only. Trouble concentrating and memory loss were listed as possible side effects, but that was an understatement. As far as weight loss, I don't believe it should be approved as a weight loss drug. It does work like that. I lost 40lbs in as little as 2 months. My family and friends were so scared for me as I was not overweight to start with. I could not eat. Nothing tasted good, I did not feel good. It did help with the migraines, really helped, so I stayed on it for awhile...If you have migraines you know it was a tough choice for me to decide to go off the medicaiton. The worst part however were the violent thoughts that I started having, and this was finally the last straw. This drug is frightening to me. I know, I know, everybody's different, and not everybody would have these side effects, but I have never had side effects from any other drug and I am very healthy, I exercise, and I'm pretty darn average. Anyway, I think the FDA made a smart choice.

    July 16, 2010 at 12:08 | Report abuse | Reply
  5. Complex

    If you've never had a weight problem, please don't feel obligated to spew your uneducated opinion on the matter. Obesity is a complex and largely pyschological condition – and if you have never had an issue with your weight, you cannot begin to understand all of the contributing factors. Most of the people on here complaining about obese people raising costs of their insurance are obviously not even well-educated enough to understand the system and how it works. Smokers and smoke related ilness cost the industry billions – and their actions are actually harming others. Why waste time and effort being so hateful about obesity? Most of the people who are militantly hateful about obesity are insecure and have way too much time on their hands – go find something productive to do. Berating people based on stereotypes is ridiculous. The media has created this hype around obesity (just like they do about everything else) and much of it is just NOT TRUE! Sure, some people are overweight because they are lazy – duh. Not a big newsflash. But the stereotype does not reflect the true origins of this group. Shame on every one of you who has come on here only to belittle those with a problem. Shows your true character. You must make others miserable to elevate yourself to a level where you can even tolerate being you. Sad.

    July 16, 2010 at 12:33 | Report abuse | Reply
    • Inkt1

      Ahhh, yes-I assume you have battled nicotine addiction and understand its complexities to make such statements. Both are real problems that should be addressed–I guarantee that the "obesity problem" actually stems from an eating problem coupled with a gross lack of knowledge regarding exactly how HARD you need to exercise. Walking is not exercise. You should push yourself to the brink. I'm in the best shape of my life and every workout I still collapse at the end of some sets. It's SUPPOSED to be hard.

      July 16, 2010 at 12:45 | Report abuse |
    • Complex

      The problem there is, you don't need to smoke to live, but you MUST eat food to live. I was not saying anything about addiction – though that is a factor for some obese people. And as far as exercise, who said anything about walking? If you are going to address statements I make, how about making your response relevant to what I am saying, instead of just using it as a chance to spread more discord? LIFE is hard, as evidenced by your sob story above, but again, has nothing to do with my post and your DIRECT reply to it. You are in the best shape of your life? Great for you!

      July 16, 2010 at 12:51 | Report abuse |
    • Inkt1

      Speaking of taking things out of context–how DARE you call my story a sob story!!! It's a story of VICTORY. And again–how was your battle with nicotine? You didn't answer my question...

      July 16, 2010 at 13:37 | Report abuse |
    • Inkt1

      sob story
      1. A tale of personal hardship or misfortune intended to arouse pity.
      2. A maudlin plea given as an explanation or a rationalization.

      July 16, 2010 at 13:50 | Report abuse |
    • Inkt1

      figured you'd need that

      July 16, 2010 at 13:50 | Report abuse |
    • Leah (TXanimal)

      The bottom line here is twofold: accountability and affecting positive lifestyle changes. Whether the problem is stress, illness, laziness or indifference, the inidividual needs to OWN the problem in order to address it. Someone with a psychological connection to obesity needs to form healthy HABITS to address the underlying issues, not rely on a pill to magically make the problem go away. Being healthy is a lifestyle change...mental AND physical!

      And why would a person who has never had a weight problem be "uneducated" in matters of weight management? There might be the random person making hateful statements who has a freakish metabolism, but the majority of us who get frustrated with "excuses" don't have weight problems because we CHOOSE not to! We all have stress, we all have multiple responsibilities and we all have temptation. There are times when we'd like to reach for a bag of chips because we're sad or stressed, but we choose to go for a walk instead. We'd like to sit on the couch after a long day at work, but we know that we can't stand up our weight training partner. We'd rather order a pizza instead of grilling some chicken and veggies, but we choose to put in the extra effort. It's not easy for us either! It all comes back to lnkt1's point earlier – it's simple, but it's NOT easy! There are NO shortcuts to anyplace worth going.

      July 16, 2010 at 14:00 | Report abuse |
    • Leah (TXanimal)

      @lnkt1: Thanks for sharing your "victory" story (I like that!). I've been working in the fitness industry for years now, and it never ceases to amaze me what the human body & spirit can overcome. I've trained and trained with people from many walks of life, and it's unbelievable what a person can do once they make up their mind to do it. I have a friend with MS, fibromyalgia and severe depression who lost 120lbs over the course of a year and a half. She ate to comfort herself and then wouldn't go to the gym because she hated the way she looked. A doctor told her she'd be dead in 5 years if she didn't lose 50lbs...she ended up at my gym and now she's training for her first powerlifting meet. She is my hero!

      July 16, 2010 at 14:09 | Report abuse |
  6. Phil

    They wrote that Qnexa is hard to pronounce? How is that hard to pronounce? Everyone must be stupid according to this writer.

    July 16, 2010 at 13:01 | Report abuse | Reply
  7. Bravo1

    Diet + exercise. Our society is so "quick fix" and lazy that we need to have a pill for everything. This is an illustration of no one wanting to sacrifice for a result. The math is easy, burn more calories in a day then you take in. But people would rather risk their long-term brain, liver and kidney function so they can get skinny eating Big Macs and bon-bons.

    July 16, 2010 at 13:41 | Report abuse | Reply
    • Leah (TXanimal)

      I think this is what concerns me the most. There's little or no incentive to develop healthy habits or make significant lifestyle changes when one can simply pop a pill.

      July 16, 2010 at 21:38 | Report abuse |
  8. karen

    The comments I have read and the extremly critcal and degrading remarks are symptoms of a long history of belief that obesity is a moral issue rather than a medical issue (what ever the cause). Frankly a lot of you need to grow up and develop some human compassion. Many of you hide behind tag names so that you do not have to responsible for your actions.

    July 16, 2010 at 16:45 | Report abuse | Reply
  9. karen

    Because of the anonimity most of you feel very comfortable engaging in verbal and emotional abuse. It is the very types of comments that were put in quotes that actually frequently impede those generally trying to lose weight. Our society in general tends to create great hurt while beliecing that they are helping. Read the research.

    July 16, 2010 at 16:59 | Report abuse | Reply
  10. Jim@goingFitness

    I'm personally glad they voted against this. The chemicals in this drug will do more harm than good long term. Just get eat right and exercise if you want to lose weight. It really is as simple as that. No studies or data has been release showing that this drug even worked to begin with.

    Go fitness and do it naturally and you won't regret it.

    July 16, 2010 at 19:37 | Report abuse | Reply
  11. CA Girl Living in MD

    OMG I'm truly shocked at the comments I'm seeing from so many of you. I have been taking Phentermine with success and have been on Topamax for almost 2 weeks. Yes the first couple of days I did experience some fingertip tingling, diet soda didn’t taste right and one day I forgot how to put my bra on (which I thought was funny). But those side affects went away. I think the big bonus for me is that it will help the migraines that have returned ever since the car accident I was in last year. I have already lost 5 lbs in almost 2 weeks and I couldn’t be happier since I had hit a plateau several months ago. Currently I work out 6 days a week and over eating is definitely not my problem. But where my problem lies is that I have Polycystic Ovary Syndrome, Metabolic Syndrome, and in 2005 I was considered a Pre-Diabetic. My Endocrinologist told me that I will continue to struggle with this for the rest of my life and it really doesn’t matter what I eat or how many calories my diet is. With my conditions my body is working against me. No one has forced me to take this medication; I take it on my own and I pay a pretty penny as my military insurance does not cover it.

    July 21, 2010 at 10:00 | Report abuse | Reply
    • Loves Dogs

      I'm not believing all the comments that I am seeing either. I have also taken both of the medications together (Phentermine and Topamax) to lose weight and it absolutely worked!!! Nothing else I did made any difference in my weight. After having a total hysterectomy in 2006 (my ovaries were removed) I went into chemical menopause which isn't fun. My hormones were all over the place and I gained weight. All my life I have been a size 4 but without changing my eating habits or my exercise habits, I gained 30 pounds in the next 2 years. My doctor said I had POCS Polycystic Ovary Syndrome and in 2010 I was considered a Pre-Diabetic (runs in my family). This medication helps burn off the excess fat around your middle, really revs up your metabolism, supresses your appetite, and makes you feel satiated while eating a very low calorie diet. You have to check your blood pressure 2 times a day to make sure you are OK. Yes, there were side effects. Memory loss, mental confusion and dry mouth. BUT, it took me 3 months to lose 45 pounds without exercising. After I got off the medication, I started doing cardio (for 30 minutes) and exercising with weights 4 times a week. I did this all under the care of a magnificent doctor who spends tons of time doing research. He took the medication himself as well. I will be 55 years old in October and have never felt better in my life.

      July 23, 2010 at 15:29 | Report abuse |
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