Will Qsymia Make You Thin?
MED’s Apovian weighs in on just-approved weight-loss drug
Anti-obesity wonder drug or a potentially dangerous substance begging for a recall? That’s the debate sparked by Tuesday’s federal approval of Qsymia as a prescription drug for weight loss.
After the most obvious question about Qsymia (it’s pronounced kyoo-sim-EE-uh), the second most obvious question is whether the drug works. Yes, with warnings about its use by certain patients, says Dr. Caroline Apovian, who heads Boston Medical Center’s Nutrition and Weight Management Center. In fact, the School of Medicine associate professor has already prescribed a medication that’s a component of Qsymia for some of her patients. (Qsymia, formerly called Qnexa, includes two previously approved medications—one a stimulant that suppresses appetite, the other an anticonvulsant that controls seizures.)
The U.S. Food and Drug Administration (FDA) initially rejected the drug in 2010, but relented after reviewing new data presented by the manufacturer this year. In announcing its decision, the FDA said it had approved the drug for patients whose body mass index (BMI) is 30 or higher (i.e., they’re medically obese) or who have a BMI of at least 27 (medically overweight) plus at least one weight-related complication (e.g., adult diabetes, high blood pressure, high cholesterol, etc.)
The FDA warned that certain people should not use Qsymia, including pregnant women. The drug can cause birth defects if taken early in a pregnancy, even before a woman realizes she’s pregnant. (Women of childbearing age taking the drug are urged to use effective contraception.) The FDA warned that glaucoma and overactive thyroid patients, people taking antidepressants known as MAOIs, and those allergic either to Qsymia’s stimulant (phentermine) or anti-seizure medication (topiramate) should avoid the drug as well.
Critics have noted that the stimulant in Qsymia was also a component in Fen-Phen, a diet drug craze in the 1990s that ultimately was discontinued after evidence linking it to heart valve problems. (The stimulant was not the cause of those problems, according to WebMD.com.)
BU Today asked Apovian to help address some of the questions surrounding Qsymia.
BU Today: When did you begin prescribing it off label, and why?
Apovian: I began off label as soon as I heard about Phase III [randomized, controlled multi-location] trial results a few years ago. Fifty percent of patients we see get prescribed anti-obesity medications in addition to diet and exercise, and we see 450 patients per month. The trial results of Qsymia produce the best weight loss we have seen since the era of Fen-Phen.
What’s the significance of the FDA’s approval? In the arsenal of weight-loss weapons, how important is Qsymia?
It’s the second approval of an anti-obesity agent in 10 years and the best weight-loss agent. We need more drugs for obesity, as many drugs as there are for type 2 diabetes and hypertension.
What warnings and contraindications has the FDA placed on Qsymia?
Topiramate, one of Qsymia’s components, is teratogenic [can interfere with fetal development], and another component, phentermine, can increase heart rate and blood pressure. So women of childbearing age and people at risk of cardiovascular disease should watch out.
What about critics who say weight-loss drugs generally don’t work well and can be dangerous, as in the case of Fen-Phen?
We have evidence that a ten percent weight loss improves mortality and co-morbidities for obese patients, and doctors will evaluate the risk-versus-benefit of Qsymia, just like they do with any drug for other conditions. Weight-loss drugs work if used properly and with diet and exercise and behavioral modification of lifestyle.
I wonder if drugs like this can become a crutch, an excuse for patients to ignore diet and exercise as part of their weight-loss plan?
That’s the same as saying that drugs for type 2 diabetes are a crutch—just stop eating sugar and carbohydrates. Obesity is a disease, not a matter of willpower.
How prevalent do you expect physicians’ prescription of Qsymia to become?
I think it will be used as an adjunct to diet and exercise and behavior modification as a first-line medication, if the patient has no contraindications to using the drug, such as childbearing potential and inability to take contraceptives or uncontrolled blood pressure or heart disease.
Obesity is a disease, and we are seeing that the paradigm for obesity treatment is shifting. We are seeing drugs becoming available because doctors, laypeople, the FDA, and the research community are realizing that obesity causes much disease and mortality. This is only the beginning. We have safer surgeries available, diet and exercise, behavior, and some medications coming out—a confluence of treatments that can be used concomitantly to treat both type 2 diabetes and obesity. We still have a treatment gap for [people with] BMIs of 30 to 35, but it is closing. We also have a certification exam for obesity medicine starting in November of this year; we have created a new sub-specialty called obesity medicine. This will enable primary care physicians and other specialties to have skills so that they can manage obesity and the medications being approved for it.
Last I checked, these people are in the business of making money and many just want to KEEP YOU SICK. So when I hear of miracle drugs, I can only start wondering of the secondary effects and its harsh consequences on the people taking them….
Which pharmaceutical company makes Qsymia? I couldn’t find it online. I know that Dr. Apovian received funding (3,250) from GlaxoSmithKline as a consultant all four quarters of 2010 (see Dollars for Docs). IRE and the public expect that journalists, even at an university, ask a doctor about his/her financial conflicts of interest and report on them, that is, whether there are or are not any. We have the right to know up front.
Additionally, I found online and copied and pasted the following information, which is a caveat for all those interested in this new drug. Furthermore, I’ve read, recently, that the real proof of safety of new pharmaceuticals comes from the post-marketing reports of the patients using the drug, not from the FDA and the short-term clinical trials. I seem to recall that waiting 7 years is considered a good idea.
You can find the following online:
This doesn’t calm the fears of Dr. Michael Lauer, a cardiologist at the National Institutes of Health who was on the panel of experts that advised the FDA about the drug. Lauer and one other panelist voted against approval, but 20 panelists endorsed the drug in February.
“I believe that if the public were to ‘buy’ (Qsymia) after FDA approval, it would run the risk of severe, even fatal, consequences from another diet lemon,” Lauer writes in Tuesday’s issue of the Annals of Internal Medicine.
“If we think about the history of obesity medications, we’ve seen plenty of lemons. Ephedra, fen-phen, phenylpropanolamine, and sibutramine had to be withdrawn from the market because of cardiovascular toxicity. Rimonabant was approved for sale in Europe, but was never approved in the United States because of severe psychiatric side effects,” he added.
Lauer is not the only opponent. Public Citizen, a consumer group, has been campaigning against the drug, too.
Jane’s question deserves a response from Dr. Caroline Apovian.
I wondered about the First Amendment issues that governement regulation of advertising might create and went to the FDA website. It was very interesting. While at that site, I found a February 19, 1998 letter (NDA# 20-700) from the FDA’s Division of Drug Marketing, Advertising, and Communications in which Vivus, Inc. was found to have violated the Federal Food, Drug, and Cosmetic Act and applicable regulations specifically in Broadcast Advertisments, Direct-To-Consumer Journal Advertisement, a January 26, 1998 Press Release, and Form FDA 2253 Submissions (promotional materials). This raises the question of where the BU Today interview fits in the slippery slope of advertising. The letter is at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticesofViolationLetterstoPharmaceuticalCompanies/UCM168287.pdf.
Qsymia is made by a pharm company called VIVUS. You can find this info if you scroll to the bottom of the website for the drug (http://www.qsymia.com/).
Do you suppose that Vivus might have agreed not to advertise its product directly to the public for some period of time? Also, I wonder what the pricing will be for this drug. How expensive will it be? Will it be reimbursed? Does Vivus have a marketing plan for introducing Qsymia to medical professionals? How many Vivus reps will be targeting how many doctors? Will the targeted doctors be those who are already prescribing obesity medications?
This is from Wikipedia: [Topiramate is the anticonvulsant in Qsymia]
A GlaxoSmithKline-sponsored Phase IV study suggested that cognitive side effects may be more common with topiramate than with lamotrigine. In studies of healthy volunteers, therapeutic doses of topiramate for bipolar disorder produced greater cognitive deficits than lamotrigine, including short term memory loss and word-finding difficulty.
Side-effects reported by > 10% of subjects in at least one clinical study (listed by prevalence):
paresthesia (numbness & tingling) (23.7%)
upper respiratory tract infection (17.5%)
anorexia (loss of appetite) (13.3%)
memory problems (11.2%)
Side-effects most frequently leading to discontinuation of therapy with topiramate:
psychomotor slowing (4.1%)
memory problems (3.3%)
That same study also reported that in adult patients with Bipolar 1 disorder who were already receiving either lithium or valproate, the addition of topiramate did not produce a statistically significant improvement versus placebo, while adding the above adverse reactions.
Rarely, the inhibition of carbonic anhydrase may be strong enough to cause metabolic acidosis of clinical importance.
The U.S. Food and Drug Administration (FDA) has notified prescribers that topiramate can cause acute myopia and secondary angle closure glaucoma in a small subset of people who take topiramate regularly. The symptoms, which typically begin in the first month of use, include blurred vision and eye pain. Discontinuation of topiramate may halt the progression of the ocular damage, and may reverse the visual impairment.
Preliminary data suggests that, as with several other anti-epileptic drugs, topiramate carries an increased risk of congenital malformations. This might be particularly important for women who take topiramate to prevent migraine attacks.
In March 2011 the FDA notified healthcare professionals and patients of an increased risk of development of cleft lip and/or cleft palate (oral clefts) in infants born to women treated with Topamax (topiramate) during pregnancy.
Topiramate has been associated with a statistically significant increase in suicidality, and “suicidal thoughts or actions” is now listed as one of the possible side effects of the drug “in a very small number of people, about 1 in 500.” 
As I’ve been rethinking this article, it would be a lot more interesting if the BU journalists did a little investigative reporting. Wouldn’t it have been more interesting, if some of the BU cardiovascular people weighed in on this new drug or if the bioethicists had a stab at it or someone who knows how clinical trials are run (12 week trials? or were they longer) or someone who could address the FDA’s expert panels (who sits on them and what conflicts of interest do they have, if any)? As it stands, the article is pure advertising. Any thoughts about this?
Dr. Lauer In the News
June 27, 2012 : Journal of the American College of Cardiology
From hot hands to declining effects
Michael S. Lauer, M.D., Division of Cardiovascular Sciences
This editorial discusses the risks of basing treatment decisions on clinical trials with small numbers of events.
I took one of the ingredients for something else years ago…lost more weight than I wanted to & stopped. My heart is fine & any small side effects immediately ended. I believe it’s safer than bypass sugery. If the person changes eating habits after losing the weight, it will be quite succesful. Maybe the obesity epidemic can be addressed in this way, without $50,000 risky surgery?
Do you know what the cost of the medication will be? Will it be covered by a patient’s medical insurance policy? (Maybe not until obesity is considered a disease and not the result of a lifestyle that’s difficult to change.) How long will the patient require the drug? Will the weight loss be maintained without the drug? Will the drug continue to be effective after years of use? I don’t think any of those questions have been answered.
I have been on Qysmia for the last 2 weeks, After my doctor prescribed it for me I found that not only did UHC not cover it, but NO insurance company did, I searched the web and found their site and applied online for a program they had and was rejected for some reason… Being a nurse, I didn’t stop there knowing they often send out coupons and such to help costs of expensive drugs so I then phoned the Pharmaceutical company and they enrolled me in a program over the phone and said that sometimes the computer doesn’t recognize some of the replies so with that all was good again. The first 2 week dose was free (which was good since I was not sure I could tolerate it); the cost there after is $75 per 30 day supply. They enroll you in a “loyalty” program and give you a prescription code you give to the pharmacy and voila! I would recommend anyone who was thinking of trying it, to go this route. At least if they could not tolerate the medication, it would not cost them anything.
I had to have an authorization with my insurance in order for them to cover but I do pay $50 for my 30 day supply. There is certain criteria you have to meet in order to be on Qsymia. You are also required to meet with physician and meet new criteria to continue drug therapy over a course of time. I’ve been on it for almost 3 months and have lost 30 lbs. My appetite is suppressed, but I make sure that I do eat meals and snacks, and eat better foods. I haven’t really exercised much as I work long hours and haven’t had much time when I’ve gotten home. No complications. So far I like it!
I wonder how often doctors prescribing weight loss medications refer their patients to a dietitian. Most physicians have minimal nutritional knowledge. Maybe referring patients to someone trained to help people change their behavior to lose weight would be more effective than having a physician advise them to eat more healthfully and exercise without providing them with any strategies to actually make these changes. I’m also curious about the cost of the medication versus the cost of seeing a dietitian. Obviously popping a pill will be easier than making the lifestyle change, but it seems to me that treating the cause of the disease, in most cases an unhealthy lifestyle, would be more effective than taking a medication to treat the symptoms of the disease.
A thyroid problem is one possible reason for weight gain. The thyroid gland is a very small organ located in the neck. If it is underactive, weight gain will occur until the thyroid problem is corrected. Usually thyroid medication is prescribed. And i dont think Qysimia is good for anti obecity procedure.
I was recently prescribed Qsymia. I gained a lot of weight in a short amount of time and I eat like a bird. My daily calorie intake is around 1200 calories. I have Polysystic Ovarian Syndrome and as a result – weight gain and inability to lose, high blood pressure and borderline diabetes. My greatest weight was 185. My lowest before three kids 125. Despite exercise I could not lose weight. I am awaiting it through the mail as this is the only to get it. Haven’t tried it yet. No it is not covered by insurance and it cost me $159.00 for a 30 day supply. They will give you a free 14-day dose with prescription. Also, I had to request a referral to an endocrinologist because I had health issues for years that my primary care doctor(s) were not addressing.
I was recently prescribed this as well, awaiting its arrival at the moment. Are you taking it yet? and if yes, are you noticing any side effects or progress?
Never had any side effects with the 14 day trial after taking a week of monthly Rx feet, left arm, face tingles, seeing the doctor tomorrow for follow up. I’ve lost 8 Ibs already. I love not being hungry but its not worth feeling this strange…
I’ve been on Qsymia for about 2 weeks and have not lost any weight. I have actually become pretty sick some sort of respiratory thing and am thinking of coming off it I also have developed an irregular heartbeat and feel horrible. Which of course has lead to me eating worse and not working out because I feel terrible. I thought these drugs would simply suppress my appetite they are totally fucking up everything in my body and I am pretty sure I wasted $75 trying them out as I only used the samples and do not like them at all. I don’t think they seem safe.
For the past 12 weeks, I’ve been on Phentermine and Toperimate which are the combination of drugs that make up Qsymia. My pharmacist suggested that I take these rather than the Qsymia in order to save money since my insurance will only cover generics. I take the Phentermine in the morning before breakfast and the Toperimate at night before I go to sleep. I’ve lost a total of 18 pounds, I have increased energy, and quite honestly I feel better and happier than I have in years! My blood pressure has remained low along with my heart rate, and the only side effects I’ve had with this medication has been dry mouth. I sleep like a baby.
My only problem now is my physician who refuses to write another prescription for the meds because she says the weight loss “has slowed down” which shows that the medication has lost its efficacy, and that the risk/benefit of using it doesn’t support further use. I explained to her that I am a woman who is past menopause, and came in with a BMI of 35, and a cholesterol level over 300! At the time that I came to her, two months prior to starting on the medication I was gaining 1-2 lbs per month while bike riding 10 miles 3 times/week. I’ve lost weight on my own before, but nothing I was doing on my own was working for me. …Until I tried this medication. And 18 lbs in 3 months is a good rate of weight loss.
I’ve had no adverse effects, the weight is coming off, and I cannot tell you what a luxury it is to eat a small portion of food and feel completely satisfied and not think about food again for hours. I feel happy and healthy and I can focus on other things beside eating and feeling fat. It’s completely turned my life around, and now this twit tells me that the risk/benefit of taking this drug is too great to continue?? So what then is the risk/benefit of OBESITY? …Heart disease? …Diabetes? …Stroke?
What about quality of life? How does that factor into her risk/benefit analysis? How does it feel to not go to the beach when it’s literally 5 minutes from where you live? Or to not wear shorts in Florida in the middle of summer when it’s 90 degrees in the shade and 100% humidity?
I think that obesity for all of its prevalence, is not well understood by the medical community. It is apparent even in the comments here that it is typically viewed as a matter of gluttony or weakness rather than a genetic condition. This, in spite of the fact that I am fairly certain that most of us know, or have met someone in our lives who can literally “eat like a horse,” and not gain an ounce. The actress Courtney Cox is one of those people I read about who can eat anything she wants, and does so with no weight gain. So if that’s true, why shouldn’t the reverse be true as well? Not everyone who is overweight eats like a pig. Some people just gain weight very easily — and if you don’t understand that, you’re not one of those people.
I hope that one day the science of obesity and weight loss progresses to the point to where it is well understood as a medical condition that can be safely treated with medication in the same way that depression (chronic, not situational), is now understood to be a chemical imbalance in the brain. Like obesity, it was formerly thought to be a sign of weakness initially by both the medical community and the general public. Later, it was treated solely with psychotherapy, and now it is accepted that the best treatment for depression is a combination of psychotherapy and medication. …And that’s medication for LIFE btw – not short-term, because chemical-imbalance based depression is a medical condition – not a weakness, and does not go away on its own, and will reoccur in the abscence of medication.
And my hope is that one day medicine will catch up to the true causes of obesity in the same way. In the meantime, I have to find an understanding physician who will support me in my effort to improve my health and my quality of life.
Here, here, well stated!
We who struggle with weight loss/control/management or maintenance are not a group of lazy gluttons with our heads in an ice cream carton 24/7. There is something metabolically and/or genetically different that has yet to be discovered because no one is looking. This is a life-time issue that does not miraculously resolve itself once one gets to a lean weight. It is the same as saying once one’s blood pressure medication stabilizes the blood pressure stop taking the medication because everything is fine now. Neither medical issue will remain resolved without continuous medical intervention. Although the thyroid medication did lower my blood pressure which makes me wonder what the correlation between my endo-system and some of my other issues including weight control. It will be a good day when doctors begin treating the whole patient instead of treating individual symptoms.
I as well have worried about when I stop taking the medication what will happen. I had one skinny Dr who wanted me to lose at least 3 lbs a month to keep prescribing it! I was so anxious and stressed on weight day. I wouldn’t eat for the week leading up. I found a better Dr who said my 1 lb a month was exactly what you wanted because you had a better chance of keeping it off. I have been on Qysymia for 1.5 yrs and have lost over 52 lbs and gone down 7 pants sizes! I feel and look better than I have in years. The Dr told me that I am now at the bottom of the BMI scale and will need to start weaning off after the holidays. Im so worried the weight will come back because I was already eating healthy and exercising for a year with no results before I started the pill. I can’t naturally lose weight. I just hope I can naturally keep it off.
I started taking Qsymia November, 2012 and I was 300lbs. It is now July, 2013 and I now weigh 220lbs. I still have weight to lose but I feel this drug saved my life. My whole life I’ve had an eating addiction and was constantly craving very unhealthy things. As soon as I started taking this I didn’t crave anything. I would still get hungry but I would make much healthier choices and wouldn’t over eat which is so unlike me. I have been off the pill a few weeks now and I continue to eat a healthy diet and work out regularly. I still have no cravings and just the site of fatty heavy foods make my stomach turn. The only side effect I had was tingly feelings in my feet that would last for a minute a day. Other then that it was a great experience and I highly recommend this to anyone who has weight issues.
I have been on Qsymia since May 2013 5 months and have lost 44 lbs. I still have weight to lose. I am completly happy with how the medication has worked for me. At 62 yrs. old I had never been on any medication but at 254 lbs my blood pressure had started to inch up. I have tried every diet out there. Personal trainers, gyms, and the weight always comes back. My bloodpressure is back to normal…no side effects except the little tingly feelings in my feet that go away. Still on no medications. I highly recommend Qsymia.
Donna, I so feel ur pain!! OMG!!! I have tried and tried to loose weight without much success!! For the last 2 years, I have gained over 50lbs! I am sooo depressed and considering lipo!! I am 45yrs old, I have hypoglycemia, hypothyroidism, and am in menopause….so these things are making it impossible! I hate it when skinny people say, just eat less, exercise more or put in less than u burn off! Oh, that makes me hot!!
Maybe u should look on some websites for the meds, if the dr wont give it to u…the best of luck, Donna!
This does work but if I eat to much while I’m on this medication I feel sick.
I have been on Qysmia for four months and my weight loss has been minimal.I have lost 12 pounds and I honestly think that weight loss is due to me attending body pump classes at a local gym twice a week. I do feel that the drug did curb my appetite in the beginning, most of my weight gain had not been from over eating but from taking steroids for a respiratory infection. I gained 35 pounds in less than a month. My doctor told me it would come right off, well it did not. I am about to discontue the drug due to the side effects which I believe are mainly caused by the migrane side of the medication. I have decreased vision. I am not a depressed person, but this medication will make you think of sad things. For example, I could be grocery shopping and for no reason at all I would think about both my parents dying in a car crash and I will tear up. I literally have to tell myself this is the medication and then I am fine. I also have trouble spelling words and remembering simple things at times. These are all side effects from qysmia. Because of these side effects, I have decided to get off the medication.
Wow I am so glad you shared your experience because I have been having the same side effects with really sad thoughts. I have to reel myself in and remind myself that the medication is doing this to me. I decided to stop afyer two weeks.
I just started taking the medication 8/30/14. Before my doctor prescribed it, he sat with me and we completed a full in depth diet plan with goals and exercise expectations. I worked on this for 2 months and when I hit a 10lb loss with those changes, he then was willing to offer 1 month ONLY on Qysmia as a step in the process. My doctor is connected to My personal MyFitnessPal, My online workout journal and he requires a check in every month. He is super involved in this becoming a true life commit for me, I appreciate him to the moon and back. I can only hope everyone has similar support from their provider, if not I suggest finding it. Good luck everyone and many years of health and well being.
I started taking Qsymia in March 2014 I was 140. It worked for me, so after 7 months and 15 lbs lighter, I decided I wanted off. So my doc decreased it within 2 months. Everything seemed fine until my period hasn’t shown up. Now I’m getting hot flashes and at the same time itchy (like my skin is crawling, mosquito biting)… I’m 41 and I know these are symptoms of menopause and it can start at that age, but what are the chances it starts exactly when I quit qsymia?! I was totally regular before I quit.. like clockwork. Anyone have the same issue?? Qsymia causing menopause??
I’ve been on qsymia for 3 weeks and 2 days and I’ve lost 17 lbs which is great but I have like all of the side effects. I have a doctors appointment June 11 2015 and I’m getting off them. I hate these side effects. So not worth it.
I’m 200lb. and id like to lose at least 40 to 50lbs. Ive tried everything out there from lipozine to the friut pill and slim fast pm thing that is out there to just slim fast and eating health. I keep mygrains and have a hard time working out as far as push ups and sit ups. Ive tried losing weight and my pcp tried putting me on metformin witch didnt work and she tryed something else and it didnt help eather. Im gonna talk to heer about Qsymia, but after reading some of these coments im not so sure. Some are good some not so… but i no if i started seeing result i could really set my mind to try and work out and eat healthy and start walking again and try to do shape and tone exersices. is qsymia wearth taking and do you thank i should even worry about talking to my pcp about it????
I have been taking the Qsymia for two weeks. I lost 8 pounds but the side effects are not worth going down this path for my weight loss journey.
I have tingling in my fingers, toes, and middle of my scalp. I have episodes of saddness, where random sad thoughts pop in my head that make me cry. This is not my personality. I am typically a positive happy person. I don’t like the way this drug makes me feel, it’s actually scary to me so I am discontinuing.