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Subscribe to RSSThe U.S. Food and Drug Administration approved the new weight loss pill Qsymia on Tuesday, adding to a very skimpy arsenal of drugs Americans can take to battle severe obesity -- and adding a last-minute name change after two years of wrangling over whether to approve the drug.
Qsymia (pronounced kew-SIM-ee-ah) pairs an old stimulant drug with an epilepsy drug to try and bring some options to the two-thirds of Americans who are overweight or obese -- and who have higher rates of heart disease, diabetes, stroke and cancer as a result.
“Obesity threatens the overall wellbeing of patients and is a major public health concern,” Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, said in a statement. “Qsymia, used responsibly in combination with a healthy lifestyle that includes a reduced-calorie diet and exercise, provides another treatment option for chronic weight management in Americans who are obese or are overweight and have at least one weight-related comorbid condition.”
It’s the second obesity drug to win FDA approval this summer. Last month, the agency OK'd Belviq, the first new weight loss drug approved in 13 years. Qsymia combines phentermine, a stimulant, with the anti-seizure drug topiramate.
The FDA took its time in reviewing Qsymia, formerly known as Qnexa, because of fears about the side-effects, which can include a fast heart rate and metabolic acidosis, a condition marked by highly acidic blood that can, in severe cases, put people into a coma and even kill them. Metabolic acidosis can also cause kidney stones and damage bones. There’s been a growing debate over whether it’s worth the risk of taking drugs that could damage the heart to battle the growing obesity epidemic.
Diet drugs have a sketchy history in the U.S. and the FDA worries about irresponsible doctors who dispense pills from their offices to just about all comers, whether they’re in the group that’s supposed to get the drug or not. The FDA approves drugs for certain uses in certain people, but once a drug is approved, a licensed doctor may prescribe it as he or she sees fit.
Vivus, the company that makes the drug, has said it’s aware of this and has said it would restrict who can prescribe Qsymia and how. The once-a-day pill will be available only through mail order so that doctors cannot dispense it from their offices. The company also plans to educate doctors about the drug's risks, which include birth defects, and to carefully watch users for any signs of heart damage.
The agency asked for a last-minute name change from Qnexa, however. "The FDA indicated concern about potential confusion regarding the name Qnexa and worked with Vivus during the final steps of the review process to identify Qsymia as an acceptable brand name," Vivus's Dr. Barbara Troupin said in a statement.
Qsymia is approved for use in obese adults, those with a body mass index of 30 or greater, and overweight adults, those with BMI of 27 or greater, who have at least one weight-related condition such as high-blood pressure, type 2 diabetes or high cholesterol.
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.
"As was the case for the diet drug lorcaserin (Belviq), approved last month despite concerns about heart valve damage, it was also reckless of the Food and Drug Administration to approve Qnexa. Research shows the medication increases heart rate, and four patients on the diet pill had non-fatal heart attacks during the clinical trials, while none of those on the placebo had heart attacks," Public Citizen's Dr. Sidney Wolfe said in a statement.
"It is magical and delusional thinking for anyone to believe that a drug will turn off hunger without hitting other targets where it will do harm, usually to the cardiovascular system."
Vivus hopes it will be a safer successor to the notorious and now banned “fen-phen” diet cocktail. Fen-phen combined fenfluramine and phentermine -- one of the two drugs in Qsymia -- but it damaged the heart in some cases and caused a condition in some patients called pulmonary hypertension, which causes fluid to build up in the chest, bringing a feeling of breathlessness.
Reviewers say the amount of the drug phentermine in Qsymia is safer. The two drugs together seem to lower appetite while keeping patients perky. Lauer said he would have liked to see more tests to specifically look for heart problems before the FDA approves the drug.
Doctors tested the pill in more than 4,430 overweight and obese patients. About half lost 10 percent of their weight -- enough to lower cholesterol and blood pressure, reduce the risk of diabetes and early death.
The drug, which suppresses appetite, is available to severely overweight patients with related medical problems. NBC's Tom Costello reports.
Related stories on Vitals:
- FDA approves first weight-loss pill in 13 years
- Desperate to qualify for weight-loss surgery, some patients pile on pounds
- Could weight-loss surgery help end diabetes?
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I have epilepsy, and have previously taken the drug toprimate (topamax). This drug caused a lot of weight loss, memory loss, confusion, mood swings, etc. I wouldn't recommend anyone taking a diet supplement with topamax. I couldn't handle the way it made me feel, like I was empty. NO weight loss is worth that!!
When is the world going to understand that there is no magic cure for weight loss.
Has anyone seen those internet pictures of "People of WalMart?"
I can't beleive the size of some of those people who stuff their carts with huge boxes of Soda, Twinkies, Oreos and Chips! You'll never find Bananas, Arugula, Feta Cheese or Spring Water in their carts!
These are the same people who'll want Medicaid to pay for these expensive pills while they continue to use Food Stamps to buy that crap!
The FDA is still under investigation isn't it? Maybe this is their way of shifting the recent(last week) corruption scandal away from them. What a joke they are anyways. They are the Fat Cat Bureaucrat it seems.
I think they all should try this pill for a year and maybe they will melt away to nothing.
I have also taken Topamax for Pseudotumor Cerebri. This drug is horrible - it will cause you to lose weight, because you can't think straight and have absolutely no desire to do anything at all. I can't believe that this has been approved as part of a weight-loss regimen..
You wanna cure obesity? Simple.
STOP eating the way our 'experts' are telling us we should eat (e.g.- low-fat, low-cholesterol, high carb), and start eating the way our ancestors ate for over 100,000 years...
In other words, reduce your carbohydrate levels to about 20% of your daily caloric intake, and start eating more animal-based foods higher in saturated fats and cholesterol, and eat more nutritionally-dense foods such as seeds/nuts, cultured foods (yogurt, kefir, sauerkraut, kim-chi, etc.) as well as dairy derivatives (cheese, yogurt, sour cream, BUTTER) from RAW milk.
Now, I know this is complete anathema to what our 'experts' are telling us to eat. But let me ask you all a question: How's this latest diet-fad of low-fat, high carb working out for us? Our ancestors were not all fat, and while they certainly worked physically harder and moved around more, that does not account for their general health. Did you know that heart disease was virtually non-existent 150 years ago? Go ask someone in their 90's how many people they remember having had heart disease when they were little.
Also the French have historically had high levels of cholesterol (ave. over 240!) but have 1/10th the rates of heart disease we have. It's known as the "French Paradox", because 'experts' cannot figure out simple human physiology as it pertains to nutrition. This is just one example.
The rates of saturated fat and cholesterol consumption in our country has decreased over 400% in the last 80 years, but our heart disease rates continue to ever climb. Doesn't this strike anyone as strange? Let me tell you, it isn't the fat and cholesterol that is causing our hearts to explode. It's actually an inflammatory condition brought on by insulin-resistance due to excessive levels of carbohydrates and toxic foods.
Everything I have stated can be fact-checked with some simple research and a basic understanding of human physiology. Please feel free to check it out. And you're welcome.
This is actually not true. There was a study recently where egyptian mummies had a noncontrast CT to look for coronary calcium, which is a marker of heart disease, and it was positive
In addition, the word angina, which describes ischemic chest pain, has been recognized for centuries
http://en.wikipedia.org/wiki/Angina_pectoris#History
History
The concept of Hritshoola—literally heart pain—was known to Sushruta (6th century BCE).[41] Dwivedi & Dwivedi (2007)—on the condition described by Sushruta—hold that: 'It embodies all the essential components of present day definition, i.e. site, nature, aggravating and relieving factors and referral. According to him angina is chest pain which is precordial, temporary, exertional, emotional, burning like and relieved by rest. He also linked this kind of pain to obesity (medoroga).'[41]
Todays FDA approved drugs = Tomorrows class action lawsuits
Two phrases I don't trust: 1) There's a pill for that; 2) There's an app for that.
One will kill you; one will stalk you.
Low carbs all the way = controlled weight. Indy Patriot is right on target.
I also was on Topomax for migraines.........didn't experience weight loss but memory loss.....confusion........inability to concentrate...couldn't string two words together........it was terrible. Won't take it again. Would be great if a pill COULD make you lose weight.........but at THIS price? Forget it.
My wife was on Topomax for migraines. Had all the symptoms, including severe weightloss to an unsafe weight. Switched to amitriptyline and then gained all the weight back and then some.
You don't have to poison yourself to lose weight. Oh, if only there were a pill for self-discipline! Weight loss can be done with proper diet and exercise. I have lost 60 pounds (so far) by eating small portions and working out religiously. It takes discipline and concentration. And it takes time. No magic bullets. There is nothing special about me. If I can do it, anybody can.
Eric- Actually, we're both right. let me explain.
I didn't say there was NO heart disease in the past, just that it was very rare. In fact, it was generally only the malaise of the wealthy (think nobility), and that is because they simply lived a lifestyle that is more congruent to the current American lifestyle in the sense that they did not have to perform physical labor (hence the issues that arise with a sedentary lifestyle), and tended to have a much more rich diet in 'prepared' foods that consisted of carbohydrates (poor people didn't have access to a lot of sugar in times past).
Your Egyptian reference is correct in that the royals were shown to have many diseases similar to our modern times (think coronary disease, gout, diabetes, etc), but the slaves they ruled over did not! It's really more a function of their affluence than anything else.
And again, we can look to numerous other modern cultures with high saturated fat and cholesterol diets who do not have high rates of heart disease. Plus, there is no VALID connection between cholesterol consumption and atherosclerosis. The notion is based on junk science and political intrusion. Check out the documentary, "The Oiling of America". I think it handles the discussion quite well and very succinctly!
I agreed with almost everything until I read this:
How do you explain the early presentation and high rates of coronary atherosclerotic heart disease in familial hypercholesterolemia?
Interesting. I've found that, oh, wearing a green shirt in combination with a healthy lifestyle that includes a reduced-calorie diet and exercise, provides another treatment option for chronic weight management.
I've also found that, oh, let's say, playing Jethro Tull songs on the flute, in combination with a healthy lifestyle that includes a reduced-calorie diet and exercise, provides another treatment option for chronic weight management.
I've also found that watching one Marlon Brando movie a day, in combination with a healthy lifestyle that includes a reduced-calorie diet and exercise, provides another treatment option for chronic weight management.
I'm not sure what all this means, but I'm starting to see a pattern developing...
That is the problem with Americans, instead of eating right and exercising they want a magic pill to do all the work for them so they can continue to eat like pigs while sitting on their asses watching American Idiot.
Well except they say :
Well as it turns out, WATER or AIR used responsibly with a healthy lifestyle that includes a reduced-calorie diet and exercise will result in weight loss.
Exactly! The article said "Qsymia, used responsibly in combination with a healthy lifestyle..." When will they figure it out?
They will need a 10 minute commercial to list all the side effects even with their fast talker !! I always like it when they say you may die from taking this medication or have an erection lasting more than 4 hours and cause suicidal thoughts.
Big difference!!
Emaunuel is spot on. That bit of trickery is called a weasel word. Ranks up there with "helps fight" or "arquably" or "consistent with".
Emanuel: You are right of course. But, logic is not exactly at a premium. On the other hand, I have this great worm food that I have been selling for years. People who love to fish (and eating fish is healthy!) buy it by the ton. All you have to do is sprinkle it on the lawn before it rains and the worms will get hungry and come to the surface to eat it. Thus, they are an easy catch to use as bait.
and pot is still illegal ?
Check into what they're doing in Chicago about pot...
Great role model the FDA is for kids, especially obese ones.
"Hey take a Pill and loose weight, for we have approved the magic weight loss pill. No need to diet, eat healthfully or exercise--we just approved another pill to take care of your problem! You can throw away that new $2M plate---we developed a Pill just for you!"
Nice going FDA! What a neglectful contradiction you represent and regulate?
This will only be on the market until it starts to kill people. Perhaps the FDA should, instead remove the things from our food supply that are making us fat. Overly processed foods filled with things we know nothing about including growth hormones are killing us and the FDA unleashes a remedy for a side effect. Brilliant. They are so bought.
My mother developed a gluten allergy about ten years ago. Because of this, I ended up learning to cook everything from scratch (and eliminating gluten from my recipes). My carb intake dropped drastically in the process, and I went from a BMI of 24 to a BMI of 18 in two years.
My two heavier children thinned out and now cannot stand the processed taste of pre-made foods. They also don't care for eating out much, unless it's at a steak house or someplace that makes basic foods.
How about this one. I was told that I had high cholesterol at 28. I quit eating high fat foods and went back at 38. Then they wanted me on lipitor. After saying no and talking to the doctor for an hour, he asked about my sugar intake. I told him I drank a case of MT Dew a day and ate a lot of sugary foods. He says "You know your body processes sugar into cholesterol, right?"
My cholesterol level dropped 100 points in six months. Why is this not promoted by the FDA? Well, because they promote Lipitor. And another thing they don't promote is knowledge. Like, the first statin drugs were derived form the mushroom. The same thing that has been used in asian countries for centuries. And I guarantee that eating a pack of mushrooms a week will not destroy your liver.
I disagree with this doctor.
Look a new type of speed. How long before people start dropping for this.
Whoa!!!......Let the donuts and fried chicken flow like gravy in our veins!! Really? Eat less and work a little more people!! LOL!!
Everybody can't work out. Like people with MS. Think a little bit before you speak like a braying donkey. LOL??? You're an a@@hole.
sorry you have MS. Do you know about gadolinium metal used with MRI scans? What it does to you? YOu need to know all those pains may not be MS. It is not rare what it does. truth seems to be rare about what it does and getting a doc to write the diagnosis is rare, see nyas.org Fourth Annual NSF conference e briefing 13 Sept 2010 and listen to Jack Gauldie and see his slides and the fda slides and mfgr reports. The US is the highest user of this dangerous metal that dechelates if any reason or not with kidneys that can't get it out. It lingers. Also. do not use Acylcovir for mysterious skin sores with this as it will form crystals in the kidneys within 24-48 hours and kidney failure. Death is soon to follow.... do not take it without a positive diagnosis and then only if, because acylovir only is used for relief or maybe shortens the hsv attack , but that clears on it's own. usually occurs only once after age 65 or so, if it occurs. BE SAFE. NOT all drug books professional types have information about kidney function or drugs that affect kidneys. Do you know your kidney function and total radiation dose , the cumulative lifetime dose? you need to know .
yeah, NSF is real but very, very, very rare. Ive sent literally thousands of patients for MRI with contrast and never seen one case
It happens almost exclusively in those with pre-existing kidney disease--and MRIs are appropriately contraindicated in those patients
any data to back you up with acyclovir?
Well...speaking of ass holes SoSickoftheGop......i was not referring to people with MS. Maybe read a little more and comprehend a little better you miserable pos.
Every time I take the time to educate obese people to eat right, they start to loose weight. Then I teach them to continue better and add some pilates gym, then they start to feel better and before they reach their own healthy weight they are ready to change their lifestyle knowing how to prevent 85% of serious diseases is incentive and a healthy lifestyle is better than any pill.
Obese people are at high risk for heart disease if they don't already have it,and they are at high risk for diabetes mellitus if they don't already have it.Thus prescribing a medication for obese people that can cause their heart to race at a dangerously fast rate,or can put someone in a diabetic coma,is a recipe for disaster!
I can't believe the FDA approved this considering how long they drag their feet before releasing other medications that the public desperately needs.
Thank you kcstrawberryblonde1 - it took clear to your post for someone to get the big picture. Is it really worth taking a drug that could make your heart beat fast and give you kidney stones to lose 10% of your weight? For me, absolutely not. This is just another incarnation of those other diet drugs that have been pulled after someone died.
Apparently for some people it's more important to look good in your coffin.
I'll stick with being moderately healthy (even though I could lose some pounds), and live a nice, long life.
All about the money.
But the chance of helping an obese person avoid a medical complication is higher than the rates of the side effects you listed
Well, here we go again. I realize that weight loss can be a challenge, but I'm not risking my heart or any other organ by taking a pill for it. Both of those drugs have serious side effects, and I wouldn't take the pill at all. How sad that people will end up sick or dead before they remove it...and they will.
Oh, and drug companies? If you have to include a pronunciation guide for your drug name you should pick one that is easy to pronounce. That is a lousy name.
Yeah, like DEXA-TRIM. Or POUNDS-OFF, maybe.
Kinda sounds like the name given to a snake-oil product that they advertise on late-night infomercials...
BTW, if you look closer at this stuff, it's pretty much Fen-Phen v2.0...
Another quick fix scam. The ONLY way to take back one's health is to take charge of their attitude about it. I am a personal coach that combines an active work-out regime and a super food shake plus personal and group teamwork community that has been the answer to many, many people's poor health issues. Contact me @ richkovatch@live.com for a chat that will be a much needed first step for you.
/salute!
Maybe they changed the name of this product because it was tested in India and it had bad results. Like many drugs the FDA tests. Get it togther and find a drug that will get anyone up on their feet and make them not feel hunger. Thats it and stop messing around. It seems our government are the a__holes of the world.
On one hand, it's not that simple to lose weight, or else there would be hardly any fat people. I don't see how being able to be "lazy" is worth all of the crap people get for being fat in this society. The drugs are supposed to be a tool to help, not a substitute for a healthy diet and active lifestyle.
That said, I don't like the idea of this drug. The point of losing weight is to decrease your chances of health-related complications, such as heart disease and so on and so forth. What is the point of taking a drug to avoid health complications when the drug itself can give you at least one of those said complications? Is it about making people healthier or just the aesthetics of "losing weight?"
it's simple to lose weight. it's just not easy.
Stop it! You're all making sense. What about profit for the pharmaceutical giants?
Yep, loads of profit for Big Pharm, and a big cut for the tort lawyers who will file a class action suit in a few years. Of course, the people who will actually be harmed by the drug will get a few bucks in recognition of their assistance in increasing profits for the others involved, too, but it'll be a pittance compared to the money the corporation and lawyers will rake in.
The only way to be lean and healthy is to first educate ourselves as to why we get fat. The answer is not as simple as you might think. Please have an open mind and read "Why We Get Fat And What To Do About It" by Gary Taubes. It surprised the heck out of me and ...no...I am not Gary Taubes...just a guy who read his book.
I'll stick with Weight Watchers ~ it's working for me.......
i expect this drug will be of limited effectiveness, be abused and not be on the market 3 years from now.
one treatment for obesity exists and it's free: take in fewer calories than you burn.
Actually fat loss has everything to do with insulin release in the bloodstream not with calories in-calories out. Please...reead the book.
Agreed. Gary Taubes has written extensively on the subject, and his premises make a lot of sense.
How long has the mainstream medical community told us we should not eat saturated fats and cholesterol because it will "harm our arteries"? The problem is not fats, it's excessive carbohydrates.
Metabolism can have a lot to do with weight. I had a younger brother who'd order 2 Big Macs, supersized fries and a milkshake and weighed 130 lbs. I'd have 1 Big Mac and a diet coke and gain 2 lbs.
lol qsymia sound like a name
You may be thinking of IQcemia, a little-known medical condition which slowly leaches one's brain cells. Similar to septicemia, it is thought to be caused by dirty, disordered minds that exhibit an unhealthy addiction to coffee, cigarettes, and newsvines at 4AM.
Thank Christ I don't log in until 8. You had me scared for a minute there. Now, where's my smokes.....dammit, I left them at the bar again!
The FDA is f---king killing people plain, and simple.
First they attack there own scientist for trying to warn people of there BS, and now I can see why.
They are prepared to give people a drug like this?
This has too be the most dangerous BS drug they have ever approved for normal human consumption 2nd too Antidepressants.
I can't believe they are really allowing this kind of dangerous drug on the market for people who just need to lose weight.
Trust me, you take this sh-it for more then 3 months, your going to end up much worse then when you started it.
I would rather tell you too take those mind killing antidepressants before these killer drugs.
This is insane.
Later.
Don't fall for this BS - drug company once again hoping to get rich selling lies!
Huey Lewis said it best-
"I want a new drug
One that won't make me sick
One that won't make me crash my car
Or make me feel three feet thick
I want a new drug
One that won't hurt my head
One that won't make my mouth too dry
Or make my eyes too red
One that won't make me nervous
Wonderin' what to do
One that makes me feel like I feel when I'm with you
When I'm alone with you
I want a new drug
One that won't spill
One that don't cost too much
Or come in a pill
I want a new drug
One that won't go away
One that won't keep me up all night
One that won't make me sleep all day
One that won't make me nervous
Wonderin' what to do
One that makes me feel like I feel when I'm with you
When I'm alone with you
I'm alone with you baby
I want a new drug
One that does what it should
One that won't make me feel too bad
One that won't make me feel too good
I want a new drug
One with no doubt
One that won't make me talk too much
Or make my face break out
One that won't make me nervous
Wonderin' what to do
One that makes me feel like I feel when I'm with you
When I'm alone with you
All alone with you
All alone with you, yea, yea"
[ Lyrics from: http://www.lyricsfreak.com/h/huey+lewis+and+the+news/i+want+a+new+drug_20066322.html ]
In 6 months there will be commercials on t.v. stating that "if you took the drug Qsymia and had x side effects, or didn't lose weight call the law firm of...."
The madness continues.
The FDA makes a comment suggesting problems with Ephedra. What BS. First off that was a reaction against people taking too much. Guess what too much of every drug is too bad. 2nd it isn't in the jurisdiction of the FDA because it is an herbal supplement. 3rd the FDA didn't ban it George W did temporarily under pressure after the death of a professional football player with small amounts in his system.
OH YEAH FOURTH EPHEDRA IS ONCE AGAIN LEGAL TO BUY IN THE US. Try Bronkaid (ephedrine) or a quick online search for new ephedera weight loss pills. FYI don't take 20x dose and it is one of the best weight loss tools.
They're all risks, with cardiovascular side effects that can kill you, and especially if you're asthmatic, should not be taken without your physician's approval. Bronkaid is approved for asthma, not weight loss. Recommending drugs like this for off-label use is irresponsible.