FDA Will Give Another Look To Weight Loss Pill Said To Cause Birth Defects, Heart Problems

Qnexa, a diet pill that some researchers say increases risks of birth defects and heart problems, is getting a second shot at making its way to the market. After rejecting the drug in 2010, the Food and Drug Administration will review Qnexa again Wednesday.

The New York Times reports there is pressure on the FDA to green-light the drug because the medical community needs more ammunition to combat obesity. The agency is concerned that the drug could go into widespread use and thus cause problems in a massive segment of patients.

A committee of advisers meeting with the FDA will help the agency determine whether a clinical trial should be conducted before or after the drug is approved for the public. If the FDA decides to keep Qnexa in check before a study is completed, it could delay the drug’s release for years.

Vivus, the company that owns the drug, has proposed releasing it but finding a way to withhold it from some women who are capable of having children.

These sorts of decisions are part of the reason why the FDA makes the big bucks. Hopefully the agency will ensure that the drug will be able to help those who need it without hurting them, whenever it becomes available.

Side Effects of Diet Pill Still Concern Regulators [The New York Times]

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  1. Power Imbalance says:

    If you can’t loose weight the ‘old fashioned way’ i.e. diet and exercise, there’s no way you’ll ever maintain any weight loss from a pill…

  2. Dallas_shopper says:

    As a female of nominal child-bearing age who has never had a baby and likely never will, I get so freaking sick of doctors being reluctant to prescribe medications to me that have teratogenic side effects.

    I’M DIVORCED. I’M 36 YEARS OLD. I DON’T EVEN WANT KIDS.

    • Power Imbalance says:

      Teratogens don’t just cross the placental barrier in pregnant women they also cross the blood/brain barrier in pregnant /non-pregnant people so that might be why your meeting with Dr. resistance.

      • Dallas_shopper says:

        I have no interest in living to a ripe old age though; I won’t have a family to take care of me or keep me company and I have no interest in living hand-to-mouth or working part or full-time into my 70s and 80s (hopefully not 90s) just to keep a roof over my head and food in my stomach.

        For me, best case scenario is retiring on-time, having a few years of fun, then dying suddenly of a heart attack or something. That way I won’t have to deal with the pain and loneliness of being a childless senior citizen with no family.

        Depressing, but honest. *shrug* It’s the main reason I haven’t quit smoking yet and possibly never will. Why the hell do I want to live to be 90?

        • Dr. Ned - This underwear is Sofa King Comfortable! says:

          If you were a doctor, would you bother prescribing a drug with higher than normal risks, and risk being sued because of it? Even if you signed a promise not to sue they wouldn’t do it, because those can be struck down in court.

          Not saying it’s right, just that it is the most probable reason.

          • Dallas_shopper says:

            I’m an adult and if I have a condition that could be alleviated by a particular drug, even if it does cause birth defects, why the hell should I have to do without because some dork doctor is afraid of being sued? It’s sex discrimination, pure and simple. I’d sign a waiver releasing the doctor from liability if I got pregnant; of course I can’t take the pill because I’m over 35 and I smoke, and any other BC option isn’t covered by my insurance so they can’t use that security blanket with me.

            Apparently my WORD isn’t good enough. Eff that.

            I hate our healthcare system. I hate it hate it hate it hate it hate it HATE IT.

        • lovemypets00 - You'll need to forgive me, my social filter has cracked. says:

          I hear you. My mother in law passed away at 94 1/2. In a nursing home, catheterized, wearing diapers, and being spoon fed strained food. She had dementia, and didn’t know where she was, who anyone was, and was basically just existing, laying there in a fetal position with large purple patches on her skin. For months. A laundry list of pharmaceuticals kept her body alive while the nursing home took in thousands of dollars a month from Medicare.

          No thank you.

          • Dallas_shopper says:

            That’s awful. :-( I’m truly sorry she and your family had to endure that.

            That’s one of my worst fears…being in a position like that with nobody to speak for me and being kept alive because doctors are afraid of being sued. In my case, there’d be nobody to sue them anyway. But at this age, I have plenty of living family members and they’re all well aware of the fact that I would not want to be kept alive by artificial means. No thank you!

            Nursing homes can be so CROOKED, too. Any patient that they’re making a profit on is going to be kept alive as long as possible, at the expense of that patient’s dignity. It’s terrible. :-(

            • lovemypets00 - You'll need to forgive me, my social filter has cracked. says:

              My sister in law had medical power of attorney. Whenever a new ailment popped up, she told the doctors it was OK to give meds for it, because she “didn’t want to kill Mom”. When my MIL was still rational, she was adamant about not wanting to be in a home, but there was no living will or advanced directives. I’m making sure I have everything in writing.

              • Dallas_shopper says:

                That’s an excellent plan. Too often, elderly people are flogged by docs and robbed of their dignity because there’s no advanced directive or family members ignore it, or family members are conflicted about what to do and don’t want to “kill” mom/grandma/dad etc. Sometimes it’s the docs pushing for aggressive intervention, but more often than not it’s family members doing so, and if there’s any disagreement about what the patient would have wanted, the doc does everything in his/her power because there’s really nothing else they can do so they err on the side of caution, i.e. trying to avoid a lawsuit. It’s really sad. :-(

          • ChuckECheese says:

            One of my colleagues in long-term-care QM has the following plan:
            Go on a long cruise, basically until your money runs out.
            Get really drunk, take a bunch of pills, throw yourself over the railing into the ocean.

      • ChuckECheese says:

        So what if they do cross the blood brain barrier? I guess the drug manufacturers and docs knew that going in, right? Would they have the same reluctance to prescribe to a man? Maybe not. What I have learned about prescribing is that if you are a wealthy person with a lot of money or high-end insurance, or an elderly person, you’ll get virtually anything you want on request and a lot of things you don’t need. If you are a plebe, even with insurance, you will meet resistance for even the most ordinary things unless/until you opt for expensive diagnostic testing. I was once told, and believed, that this was “cover your ass” medicine to mitigate malpractice claims. Now I believe it is really a good-ol’-boy mutual financial backscratchin’, medical style.

        Case in point: I am a celiac. I travel for work. If I’m traveling for work and I eat something that has gluten in it, I will be ill within 2 hours, and crapping myself for 2 days. If I’m on the road, this is severely inconvenient. Standard antidiarrheals don’t work. Things that do work are prednisone and Lomotil. I would like a small Rx to use on an emergency traveling basis. Doc says “no can do” on either one, no specific medical reason given. He suggests I schedule an appt with a gastroenterologist that I don’t need. I’ve been diagnosed for 12 years, don’t have a relationship with a new GI doc, I’m in good health and there are no other medical treatments for my condition, so what’s the point in going to another doc to get a couple simple prescriptions filled?

        For work, I do quality management work for long term care insurance companies. I commonly see people getting PRN Rx’es for enough opiates and benzos to kill zoo animals. Most of these meds go unused, disposed of and refilled monthly. The conditions being treated don’t require this degree and amount of medication. But I’ve learned that docs like to throw pills at the elderly like parade confetti.

  3. Quirk Sugarplum says:

    Now available with a creamy Thalidomide center, for an extra burst of flavorful good health!

  4. eturowski says:

    I can think of a safe alternative that won’t cause any heart problems at all… diet and exercise. Another benefit: it’s free!

    • Mr. Fix-It says: "Canadian Bacon is best bacon!" says:

      Oatmeal also lowers cholesterol… doesn’t mean some people don’t want to hedge their bets with a pharmaceutical ‘helping hand’.

    • Dr. Ned - This underwear is Sofa King Comfortable! says:

      Hmmmm now I’m just one away from a Bingo. We need a new breastfeeding article!

    • KyBash says:

      And it works for a whopping 8% of the people!

      Diet and exercise are fine for losing up to 15% of your maximum weight and keeping it down.

      Beyond that, people are very different — what works for one person can kill another. Some people’s bodies respond well to low-carb, others to low-fat. Standard exercises will help some, it will cause muscle/tendon problems in others.

      I have to walk a fine line — if I drop my intake by too many calories, my body starts feeding on my muscles, and it shuts down to the point that even daily activities become next to impossible. On a 1500 calorie diet, I sleep 12 to 14 hours a day.

      Many times, people need something that will shock their metabolism into changing.

      • Mr. Fix-It says: "Canadian Bacon is best bacon!" says:

        I like you. You make sense. :3

      • Such an Interesting Monster says:

        I highly recommend you find a medical center or clinic with a weight-loss program or bariatric unit. They can help you figure out what works best for your body and get your metabolism back on track.

      • Not Given says:

        I had to sleep about 10-12 hours on more than 1800 calories on low fat, my hair fell out. On low carb I have no problem staying around 1800 calories.

      • Jawaka says:

        Actually it works for 100% of people. What you meant to say is that only 8% are willing to stick with it for the long run.

        • Such an Interesting Monster says:

          Well that’s not really true. Diabetes, insulin resistance, fatty liver, and other hormonal imbalances can make losing weight extremely difficult or impossible, no matter how little you eat or how much you work out. And these problems are *extremely* common in obesity.

          The upside is that with proper medical intervention these conditions can be managed or reversed which can then allow people to lose weight normally.

          The assumption that fat people are just lazy and lack willpower is simply ridiculous. Obesity is a complex issue. Cause if it were simply all about eating less and exercising more then we’d all be thin.

    • Kuri says:

      because “have to” instead of “want to” is so much better./

    • Jenny8675309 says:

      I agree! Lazy American’s wanting a pill for everything. I say get off your a** and put the donut down.

  5. dulcinea47 says:

    One of the components of this drug, topirimate, makes you stupid as hell. I took it for migraines. Loss of appetite is a well known side effect. Memory problems are also a well known side effect. I lost words like crazy. You know when you forget a common word but it’s on the tip of your tongue? With Topamax, it’s NOT on the tip of your tongue, it’s just gone, and you stop in the middle of a sentence and can’t go on b/c all the words are gone. I was so glad to get off of it.

    Also, if you read the article, all the people who take this say they gained all the weight back as soon as they stopped taking it, because DUH, they didn’t change their eating habits, they just took a bunch of appetite suppresants. If you could combine both things it might be an okay short term thing, but people just want a magic pill, which isn’t happening.

    • awesome anna says:

      Right, it’s a lifestyle change, not a diet. That’s why diets never work.., or you meet people who have been on weight watchers for 10+ years because they simply have no control over how they feed themselves, they need someone to tell them (my opinion, not a fact, no need to freak out)

  6. lovemypets00 - You'll need to forgive me, my social filter has cracked. says:

    I know I’m going to get a lot of flack for this, but I’m going to say it anyway.

    This reminds me of Phen-Fen. My mother pressured me to take it because I’m overweight. I was thankful I didn’t give into her pressures when they took it off the market and the health issues it caused came to light.

    Now we have another drug combined with phentermine, and this combination can cause some severe issues too.

    The message from society seems to be “you’re fat and unacceptable, so here’s a pill/surgery/whatever to make you thinner”. Oh, and along the way if you die from heart problems caused by the drugs or have a myriad of problems related to surgery that you didn’t before, at least you look better and can wear smaller clothes.

    • vorpalette says:

      Heh, yeah, your diet and exercise isn’t going to make drug companies and doctors any money. The pills and surgeries are the easy way out, which is what many people want–who wants to work hard to lose weight when you can just pop a pill and off it comes? I had a family member who had the surgery because it was what her doctor told her to do. She lost a ton of weight, but she still eats horribly (god forbid she drink water instead of diet Mt. Dew).

      My best friend is a prime example of what to do: she’s lost over 130 pounds on diet and exercise. She tried Alli with it, but hated the side effects, so she changed her eating habits and became a Jillian Michaels fan, and she looks amazing. She knows that she’s never going to be a “skinny” girl (she’s 5’10”), but she just wanted to be at a healthy weight and be able to shop in a regular store.

      • lovemypets00 - You'll need to forgive me, my social filter has cracked. says:

        I’m going to try the diet plan my husband doesn’t follow, the one they gave him because he has type two diabetes. I have no problems with blood sugar, but there are charts and it tells you how many portions to eat each day to try to keep a steady level. I even bought digital scales to weigh everything out that isn’t premeasured, like yogurt.

        Hope this will work better than the last time. I spent 30 days exercising, mowing two lawns with a push mower, walking 2 miles per day, and carefully limited food intake to 1600-1800 calories per day. No junk. After the 30 days I was exhausted, but hopeful. Back on the scales & I had gained weight. What a crock.

        • VintageLydia says:

          It’s possible the weight you gained was muscle mass. It’s really common to actually gain weight that first month if you’re doing exercise. The problem with our society is people are too focused on the wrong number. Weight is an important index, but body fat percentage is even more important.

          • Mr. Fix-It says: "Canadian Bacon is best bacon!" says:

            this is true. Muscle weighs something on a factor of four times as much as fat, so you could lose a lot of fat and a gain a small amount of muscle, and it would still seem like you’ve accomplished nothing (or even less than nothing!) as a result.

          • awesome anna says:

            Yes, measure inches lost! Not lbs…. you gain muscle and then you think you gained fat and then you give up because it “didn’t work” educate yourselves people. Calories in calories out. It’s really not rocket science, and I realize some people may have underlying psychological issues and that’s ok, but get help for that to. A support system, a team.. etc. You don’t gain the weight in 3-6 months, why do you expect to lose it all in 1-2 months???

      • Dallas_shopper says:

        I hear you; I used to weigh 260, now I weigh 110. Lost it all through diet and exercise. I’ve been at or below my goal weight for nearly 3 years now. So many docs for various reasons won’t even bother to counsel you about weight loss strategies but they’re quick to prescribe these stupid pills for you.

        I was lucky; at the time, my OB/GYN actually gave a crap and told me to put down the nachos and get up off my ass and hit the gym. She was right. I may not want to live to a ripe old age, but being thin and fit kicks being fat’s ass any day of the week. Not only is life more comfortable but I can wear whatever I like. It’s also less expensive since I don’t go out to eat, my clothes last much longer (fat girls can wear out a pair of pants in a month or two, and don’t let anyone tell you different), my clothes are CHEAPER since I don’t have to shop in specialty stores anymore, etc.

        Plus…if you’re going to die from something…you don’t want it to be from diabetes. It literally rots you from the inside out. It SUCKS. I’ve been watching my mother deal with it for almost 20 years now. It’s HORRIBLE.

        • lettucefactory says:

          My weight has yo-yoed dramatically since I hit puberty, but no doctor has ever tried to suggest pills to me. If I’m in a heavy phase and I see a doctor, the doctor usually ignores the issue – in fact, come to think of it, the only time a doctor has brought my weight up for discussion has been during pregnancy, which is a whole different thing.

          Granted, I’m lucky that – so far – my blood pressure, resting heart rate, cholesterol levels etc. are all within totally acceptable range, even when I’m fat. I don’t raise red flags, for now. But if doctors are in general so eager to prescribe weight loss drugs and nothing else for fat people, that kind of surprises me. It’s not been my experience at all.

          That said, I do agree that it’s hard to get good advice about this, in general. A few months ago I actually made an appointment with my primary care doctor just to talk about weight, and she referred me to a nutritionist. Which turned out to be horribly disappointing. I can get a food list from the internet, and I already know that baby carrots are a better snack than Fritos – I just need some coping strategies to stop the emotional overeating. When I tried to explain that to my primary care doctor, she looked utterly lost.

    • tailspin says:

      That was exactly what I was thinking. I went on Fen-Phen during its heyday, and it was like a miracle — I dropped about 20 pounds really quickly, with no hunger. And then I heard about all the side effects that were starting to emerge, and stopped it immediately. The weight came back as fast as I lost it, because with no more appetite suppressant you feel like you’re starving. If this new one is anything like the old combo, it’ll reverse the moment you stop taking it — a co-worker who was on it at the same time as me forgot to take her dose one morning, and by mid-morning was so ravenous she ate an entire sleeve of english muffins with a stick of butter. It scared the living daylights out of her.

      I’m more than happy to do things the old-fashioned way now — eat healthy and exercise. Learn self-control, deal with the reasons you overeat, and watch everything change gradually and safely. Sure it’s not a speedy process, but it works best in the long run.

      • Jawaka says:

        “I’m more than happy to do things the old-fashioned way now — eat healthy and exercise. Learn self-control, deal with the reasons you overeat, and watch everything change gradually and safely. Sure it’s not a speedy process, but it works best in the long run.”

        If people were willing to do this then they wouldn’t have a problem to begin with.

    • Thalia says:

      And yet, comments here are all about how we must lose weight. Because clearly being fat is “bad” as opposed to having memory loss, hearth problems, and genetic defects caused by a pill. American society is seriously screwed up about weight.

      Also, yoyo dieting is worse for you than being fat. Be fat and healthy and happy.

      • Such an Interesting Monster says:

        You mean be fat and have diabetes, fatty liver, heart disease, high blood pressure, and be happy?

        While I certainly do not recommend taking drugs like this, the alternative of being fat is not acceptable either, as it poses its own set of serious health risks, not to mention the emotional and social repercussions.

        • Conformist138 says:

          While the rates of certain ailments do go up with increased weight, there are a lot of factors that are more about lifestyle than weight alone. Plenty of thin people are stationary, or deficient in certain vitamins and minerals. Those people can be just as unhealthy, but it’s less visible than with heavier people.

          We judge what we can see, and so it’s still ok to judge heavy people for health and lifestyle problems we assume they must have. At my best (eating right every day, daily activity, etc) I tend to wind up a size 12-14. By the standards society has set for me, this makes me a fat loser who should take whatever pills I can to force my body into looking normal. By human standards, it makes me a normal, healthy person. The problem is we take people with unusually thin bodies or people who are very young and hold them up at the only model of health and beauty.

  7. Such an Interesting Monster says:

    “…there is pressure on the FDA to green-light the drug because the medical community needs more ammunition to combat obesity”

    Translation: “we’ve spent a boatload of money developing this drug and want to get it to market ASAP so we can make billions off of gullible people who think the key to losing weight is a pill instead of eating less and exercising more. What’s a few birth defects and heart problems as long as we’re rich?”

  8. Thalia says:

    Will this finally convince people that the “war on obesity” has nothing to do with health? People are considering prescribing something that causes *actual health problems* because we are so afraid of fat. This is just sick and wrong on so many levels.

  9. Loias supports harsher punishments against corporations says:

    Seriously, don’t pass a drug just because of a perceived need to have one available.

    I’m obese, but I don’t want a drug that will cause me serious harm.