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As I understand it, the biggest issue the FDA had with this medication is that in the original submission pregnancy was not contraindicated. Both of the combined medications have seen the market before, so there is little risk of recall. The side effects are serious but as far as the FDA seems to be concerned, if it causes fewer heart attacks than it prevents then it's A-okay.
Topamax's patent ran out last year or the year before, if I recall. Generic is still very expensive. Therefore this medication will assuredly be quite damaging to the wallet. I predict a month's prescription will run $250-400 easily. Maybe more, I don't know much about the coupling medication. Hope your insurance is paid up.
By the way, Topamax is colloquially referred to as "Dopamax" by many in the medical community. It has a few psychological side effects. Do your homework before gulping down some fancy new pill. You have to weigh the benefits and risks.
I am so glad someone else is alerting the public about this; unfortunately, it's in the comments and hardly anyone will know about the ill-affects of Topamax (Topiramate). It literally made me have 10 of the 12 symptoms of Alzheimer's - no joke, not being overly dramatic, and in no way diminishing what those poor people who have it go through. I'd rather have my mind whole than use it to lose weight, which did happen. However, the means did not justify the ends. I couldn't remember how to do my job that I had been doing for over a decade, I couldn't remember anything from one moment to the next, I would forget where I was driving to and would go the wrong way, I can't remember my kids' lives for the time I was on it, I was so apathetic that when and if I got out of bed I was on the couch the rest of the time, and I began having suicidal thoughts. Those are just a few of the things Topamax did to me. Check out the stories of others who took/take it on crazymeds.us if you need more convincing. It eventually didn't stop my seizures, so I stopped taking it. One of the best things I ever did.
This whole thing is ridiculous. People want the easy way on everything. They would rather swallow a pill that has possibly major side effects than eat right and get their asses off the couch and get some exercise. Pills are not the way to lose weight, lifestyle changes are.
@Terror Bird - While brand name Topomax is expensive, the generic topirimate is actually pretty inexpensive at only about 10% of the price of the brand name. The prices I saw for it on-line run from .56 to .67 cents a pill for the 50mg dose depending on quantity.
Insurance has a large impact on medication price. That being said I would never recommend buying medication online. It is poorly regulated and you can never be sure of the safety or efficacy of what you obtain. Especially from dubious sources. Buyer beware!
In the pharmacy (at least the one here) someone without insurance can look forward to paying nearly $200 for a month's supply of topiramate. Topamax is a little over $210 for an individual with no insurance.
This new medication will have it's own patent. Everyone will be paying the brand name price. It will be very expensive. If you have insurance then it may not cost you much. But someone without insurance will have a rough time paying for this fancy new pill.
Ah. It seems as though I misremembered (that or my associate is wrong and I'm right). It's just under $100 for a month of topiramate and almost $120 for Topamax. So it'd be about $150-300 dollars for a month of this new stuff. Apologies.
I just checked the price of topiramate on the RightSource website - it's $38.47 for a 90 day supply of 100mg tablets.
RightSource is an "online" pharmacy of Humana Insurance - it's used by hundreds of thousands of people, including me.
Good info, in addition Topamax has a host of other side effects. I know because it was prescribed to me. I had hair loss to the point of becoming bald as well as severe weight GAIN, not loss, but it did get rid of the migraines. FDA approved or not this pill has disaster written all over it. People should not volunteer themselves to be human guinea pigs, no weight loss is worth the medical unknown, especially when that unknown is already proven to be detrimental not positive.
I haven't tried Topamax, but I've tried soooo many other things as well as other prescriptions. There are easy, effective weight loss solutions out there. I know becasue I finally found one without crappy side-effects! I've been at my goal weight for a year, and even became a health coach to pay it forward and help others find health. If you want to read my story you can go to www.behealthyquick.com It has been a life changing blessing, without drugs!
The article says..........
A majority of panelists ultimately backed the drug due to its impressive weight loss results, with most patients losing nearly 10 percent of their overall weight after a year on the drug.
I'm sorry but if I am a female who weighs 250 pounds and after a year on a drug which has major side effects and I lose 25 pounds...........well, I think if I would just cut back on food and exercise more it would be a lot safer. Just thinking!
I agree with you 100%!!! If people are serious about changing their lifestyle and getting healthier they could average with ease 48 pounds a year without a pill. Heck, they could do more if they were really determined and had the will power. You could safely loose 72lbs in a year and keep it off.
These pills are just a quick fix with a chance of killing you faster than the junk you pile in.
Welcome to America- Land of the Quick-Fix.... (not to mention land of the FAT)... Besides if these people don't take the quick fix way out, the obesity will most likely kill them sooner anyway.
Agreed! Instead of spending $200-$400 a month (because insurance will not cover this pill unless it's medically necessary); just take a brisk 1 mile walk every day (free) and reduce your daily calorie intake (also free). By doing this, a person likely could lose a pound a week, which comes to 52 pounds in a year instead of 25. Just sayin....
Before anyone attacks me for not knowing how hard it is to lose weight: Yes I do know how hard it is. I have weighed 250 pounds (I'm 5'4") and I busted my keester to get rid of it.
I had some surgery on my brain and spinal column almost three years ago, and am very limited in what I can do now. and not even a 10th as active as I was before the surgery, so my weight really skyrocketed. but I have since been working on it as hard as I can for the last year. I have been averaging about two pounds a month. As the doctor said that's a good healthy weight loss, no pills to suffer the side effects, or the expense. and if you can do 1 1/2 - 2 pounds a month, chances are you will keep it off.
Way to go! Keep at it.
Congratulations, James. It is awesome to hear such an inspiring story. Two pounds a month is great :) Your doctor is right, this is the best way to go. It does take patience - I had to do it before :) - and it can get frustrating because while you are at it, trying to do it the right way, you see your friends dropping 20 -30 lbs a month on Atkins, or South Beach or whatever the lates is... On other hand, all of them are back to the weight they started on (or more) while I am steady :))))))))
Nothing is changed with the drug. Lobbyist and political pressure persuaded the medical guardians to give in. Shame on Johnson and Johnson. They have a history doing this kind of thing.
Why do we need a pill to fix an ailment that can be remedied with exercise and a healthy diet?
looks like more money for the medical/drug complex:
If the FDA okays it, I'm not touching it!
@ a lot of you on this forum. They make a pill too loose weight because it is what people want. Supply and Demand. People are free to choose what they eat, how much they eat, and how much they exercise. How come some people think that just because they chose to take care of themselves and exercise that someone else should be forced to as well. Yes a pill may be the easy way out, but you don't hear nearly as many people complaining about contraceptive pills, isn't that the easy way out as well. take a pill don't have a kid!
Ann Borg - what were you taking it for and at what dosage? Qnexa combo has some good synergistic effects, and the dosages of the 2 drugs it contains are in a much smaller amount than were previously used.
I have a right to eat what I want, how much I want, and exercise as little as I want. Now I have a pill that I have the freedom to choose to use. Isn't it about supply and demand, the country is 35% obese, there is a high demand, so why not make it, I would. Then I would encourage all the people to eat fastfood everyday. Make myself rich. Besides when did you last complain about taking a pill to prevent something you didn't want. Oh wait maybe that was your wife/girlfriend preventing pregnancy. whats the difference, a pill to help you not be what you dont want to be
Ah, but you forget you don't have the right to choose which side effects of that pill you may face.
Exercise alone will not help you lose weight. You need to combine exercise and drastically control caloric intake. This is a lot easier said than done and is a major commitment to lifestyle changes. All of you who are fortunate to have never had a weight issue -- stop being so GD judgmental. Even those undergoing bariatric surgery have to make a lifetime commitment to lifestyle changes, or they will put the weight back on, plus more. This is a constant uphill battle, especially if you enjoy eating the wrong foods and are constantly bombarded with restaurant commercials showing very thin individuals indulging and having a good time. Once you loose the weight, you still have to work at maintaining it for life. I would rather deal with excess weight than take this new poison the pharmaceutical company is trying to push that no doubt is going to cause major health problems down the line. There is no quick or easy solution to a weight problem.
I love these drs, especially the one who was on NBC who said she thought this drug was a good idea even with the side effects because being obese was bad for you....Ok so lets take a drug that will speed up your death! Do you wonder where her university is getting their funding from? And 10% weight loss? That is less than 3 pounds a month for someone who weighs 250#. And for how long? The minute u stop taking the pill you put the weight back on and that is so good for you too!! Anyone stupid enough to take these drugs gets what they deserve. I'm pretty sure there is also a little disclaimer that says you must eat healthier and exercise more along with taking the drugs! Gee eliminate the drug and you will live longer and it will cost you less!!! If all these "new" solutions worked for weight loss there wouldn't be a problem but even with all these great solutions people are heavier than they have ever been!!! This is the greatest fraud committed on society and the FDA is making it legal so these companies can make billions in profits!!!!
Both my knees are bone on bone and it hurts to walk for any length of time, let alone exercise. I have chronic adhesive capsulitis in both shoulders (a form of frozen shoulder) that has left it hard for me to do any kind of exercise with my arms (when they aren't suffering the effects of the condition). So weight loss is far from easy for me via exercise. While the thought of taking a risky pill makes me more than slightly nervous, at what point does one trade the risk of a pill vs the risk of a heart attack from an inability to lose weight effectively?
It's not always as easy as saying "just exercise and diet." And I can assure you that to adjust diet to make up for the inability to exercise effectively enough seemed to just leave me lethargic.
So before being so judgemental about those that might consider this pill, remember that everyone's situation is different and not necessarily so easily defined.
PM. I understand how you feel. Really, I do. The thing is, diet pills are tricky. They can be a good tool to help you loose weight - in combination with life style adjustments . As far as exercise - have you tried swimming ? Or special water aerobics - some of these are specially designed for people with "mobility" issues. They are great because they do exercise your body while being gentle :) Again, I do not know you personally so I am just throwing ideas around. No judging here :)
So the hold-up for this drug's approval is concerns about heart problems and birth defects?
Not to make light of it, but these don't seem so terribly risky given the situation many obese patients are in. Heart disease is already a leading cause of death, especially among the obese, so is there really an increase in risk?
The occurrence of pregnancy in the study group was 1%. That's about as low as you can expect, even with perfect use of hormonal birth control. With a cleft palate predicted for 1 in 1,000 births to mothers on the drug, that's essentially 1 affected baby for every 100,000 women taking it. I don't know if that's the only conceivable birth defect (probably not), but cleft palate is surgically correctable. Seems fairly low-risk, compared with something like isotretinoin (Accutane) which was recently on the market and causing numerous and severe birth defects (and Crohn's disease in users).
Obviously healthy lifestyle changes are preferable, but I know a number of people who seem to defy this. A high school friend I had, who was a competitive athlete and conscious eater, was always fairly chubby and I was perplexed at how someone so active could retain so much fat. Even now as an adult she is active in lacrosse and has only grown larger - probably obese or close to it. A fellow gym member runs a mile every morning but remains quite large and apple-shaped. I have trouble reconciling these people with the notion that activity and balanced diets are the universal answer to obesity. Maybe some people really do need pharmaceutical help.
JML, I actually gained weight while training for my first marathon. I would like to be able to claim it was mostly a muscle gain. ... but.. :)
Ah, but did you go from a healthy weight to morbid obesity during that training? I bet not. :)
It is important for the public to realize that it takes effort to lose the weight once and for all. While a weight loss medication may seem promising and a quick fix, there are risks. In addition, the side effects of many weight loss medications often leads to stopping the medication and regaining the lost weight.
Even with the help of medication, weight loss requires adjusting daily calorie requirements; either through calorie reduction, increasing activity, or a combination of both.
Relying on a medication and trying to bypass calorie adjustment may give an individual a false sense of hope in thinking the pill will solve the problem permanently without making changes to your eating and activity levels.
Thoroughly investigating the medication with your doctor and educating yourself on the risks and side effects can help you make the best choice possible to reach your weight goal while maintaining your health.
Keep in mind that the medication is only an aid to the basics of calorie adjustment; the foundation weight control.
Large amounts of leafy greens(kale is as cheap as potato chips..hell. you can even make a chip out of it that's delicious and low calorie),vegetables,meat,especially organ meats,and a very small amount of fruit.Stay completely away from wheat,corn,soy,sugars(even honey or agave),dairy( butter from grass fed cows or goats is the exception,but only in small amounts) artificial sweeteners,white potatoes, and industrial oils(canola,soy,safflower,corn..the ones that comes in big bottles).Learn to cook.That's the biggest thing.There is an adjustment period, and you'll be tired and cranky as your body adjusts to not having the addictive toxins it has gotten used to,but in a few weeks, the weight will melt off and you'll have so much energy that you won't know what to do. You don't need a pill to lose weight.It's not a bacterial infection.
How about this for a prescription?
"Shove fewer groceries down your maw - apply daily with reasonable exercise"
You have to wonder who paid who and how much for the FDA to suddenly back a drug with so many side effects that it wouldn't back previously. This isn't about the 'desperate' need for obesity treatment, it's about Big Pharma's 'desperate' GREED. The media and the medical industry distribute false information and play into the idea that it's better to be dead, sick or crazy than to be fat. Drugs like this just help people along to one of those conclusions while lining the pockets of Big Pharma with green. Shame on the FDA, they do nothing to truly protect the American people.
Quote from above: Even now as an adult she is active in lacrosse and has only grown larger - probably obese or close to it. A fellow gym member runs a mile every morning but remains quite large and apple-shaped. I have trouble reconciling these people with the notion that activity and balanced diets are the universal answer to obesity. Maybe some people really do need pharmaceutical help.
These people DON'T need pharmaceutical help. They are probably much healthier than their thinner counterparts, but the medical industry and the weight loss industry don't want people to know that you can be fat and healthy. Nor do they want you to know that healthy lifestyles - [eating less and exercising more] DON'T always result in weight loss. There are too many other factors in play. Prescribing drugs or surgery to a healthy person just because they are fat is dangerous and ultimately NOT necessary.
Im sure the members on that panel are getting some hefty kickbacks from the drug maker to vote on approving the medication. Pharmaceuticals isnt about helping people its about making money. and imo a 10% weight loss over a year isnt very significant. I wouldnt be surprised a placebo effect would have that much effect. You know your aking this pill so you eat better than normal... Neway sounds like a waste to me!
How about getting off you butt, excercise and eat right. There is NO quick fix to being healthy and fit. It's a lifestyle. And 10% of your weight in a year? Wow that's it?
I am a Nurse Practitioner and I WON'T write for it. All you have to do is eat right.
Thats it, thats all, and I know...I have done it...I was born with the obesity gene.
It's puzzling the FDA approved Qnexa so readily. "The panelists noted the importance of a follow-up study to track cardiovascular effects, underscoring ongoing caution about the extent to which the FDA has been concerned that a diet pill will be prescribed and used correctly." http://bit.ly/yeB4Es
It sounds like its only been researched enough to know Big Pharma will make a lot of money of an FDA backed diet pill.
Nowhere does it say that the FDA approved the drug. It states that a panel that advises the FDA supported it for approval by the FDA.
And to ArbyH - Thank you for the decent and respectable response. I've considered the swimming but I sort of live in the middle of nowhere. 15-20 miles one way to get to a pool open year round. But been talking with the wife about getting one of those mini-pool things that let you swim in place. Just gotta save up the funds.
And to all the jerkoffs constantly saying "just shove less food down your throat"... you're all trolling idiots. Not everyone's body reacts the same way to the same treatment. At one time this was my daily menu:
Breakfast - 1 egg, 1 slice wheat toast dry, glass of juice and apple slices..
Lunch - Salad consisting of lettuce, tomato, onion, tuna and 2 tsp fat free mayo.
Dinner - 6 oz white meat, 1/2 cup pasta, small tossed salad with fat free dressing, and a veggie like broccoli or green beans.
Only snacks were veggies/fruit, drinks were coffee (skim milk and sweetener), juice or water and no cheating. Stuck to it for 6 months (was in the military and was at risk for the "fat boy" program and losing my retirement.) At the end? Lost 4 lbs. 4 lbs in 6 months. Luckily I hit retirement eligibility and was able to get out before the my weight threatened to boot me out.
Tell me where I could have improved on my diet then? I'd be really interested in your "wisdom", all you idiots that preach "stop stuffing your face."
Thanks for the correction and the response. "Approves of" would be the better term. It seems you had a pretty strict diet and you make an excellent point that all bodies are different. The only difference I could recommend (which is stupid and pointless considering the amount of exercise you were most likely undergoing and how strict the rest of your diet was) would be to avoid juice as it tends to be both high in sugar and calories.
As far as exercise suggestions, even as a young person I have chronic knee issues as well a bad quad ( I tore it pretty badly playing sports in high school) and have found Arc Trainers provide a great work out and are easy on my joints. If your gym has them I highly recommend them.
On top of that, while it won't help directly with weight issues have you tried taking Omega-3? It's essentially a purified supplement from fish oil without all the dangerous mercury. It's great for joints, as well as a ton of other things such as brain and heart health. I've found it quite effective. Who knows, if it reduces joint pain, it might relieve some of the difficulties of exercise. Just a thought, thanks for the response and best of luck!
Why on earth would a pregnant woman take a diet pill?!?
I don't really see the phenomenal benefits of this drug at all. The article states that it can cause a 10% weight loss in obese people over a one year period. So a person who is severely overweight and weighs in at say, 305 lbs, would expect to lose a mere 31 pounds in a year !? How is that even a moderate reduction in obesity. And for that whole year, the patient is hyped up on amphetamines living with tachycardia at the same time.
Please correct me if I read the article incorrectly. But a 10% reduction in severely overweight individuals equates to bupkus. Healthwise, they are still at a very unhealthy weight. But, whatever, at least they will be a lot more talkative and expressive.
First of all, I think most health care practitioners agree that obesity is a very dangerous health condition that exacts a huge physical and psychological toll upon affected individuals. Our healthcare system is extremely taxed with the effort to care for these people, since obesity does adversely influence other conditions, and the obese have a much poorer outcome in intensive care settings.
But our desire to treat obesity should not overshadow the need to keep people safe. Primum non nocere - first do no harm. A drug that allows people to lose weight but can cause significant other health problems is not a solution. Look at fenfluramine as a classic example of a drug that ultimately increased health care spending-increased health care costs managing pulmonary hypertension and valvular heart disease, and increased legal costs incurred by the multiple lawsuits that ensued. We live in a litigious society where physicians and healthcare workers/organizations are targeted - we should be scrupulous in our methods so as to not give more fodder for the unscrupulous. Not all lawsuits are frivolous, but rushing out a medication to the masses when it is clear that there could be potential health ramifications seems foolish to me.
Obesity is a condition that results from a combination of physical, social, and emotional factors. All of the above must be addressed before successful management can occur. I believe that much of this management starts from childhood. We must learn to be responsible for our actions, and to be interactive in our own health management. And we must stop thinking as a society that there is a quick fix or magic pill for everything, because in most cases there isn't.