NEW drug releases....... (to be viewed from a perspective of horror).

[ang]

January 30, 2015 -- The U.S. Food and Drug Administration today expanded the approved uses of Vyvanse (lisdexamfetamine dimesylate) to treat binge-eating disorder in adults. The drug is the first FDA-approved medication to treat this condition.  EVER HEARD OF BINGE EATING DISORDER?  A NEW ONE!   TAKE A DRUG THAT WILL KILL YOU INSTEAD OF ENJOYING A BIT OF A BINGE?

 

In binge-eating disorder, patients have recurrent episodes of compulsive overeating during which they consume larger amounts of food than normal and experience the sense that they lack control. Patients with this condition eat when they are not hungry and often eat to the point of being uncomfortably full. Patients may feel ashamed and embarrassed by how much they are eating, which can result in social isolation. Binge-eating disorder may lead to weight gain and to health problems related to obesity.

“Binge eating can cause serious health problems and difficulties with work, home, and social life,” said Mitchell Mathis, M.D., director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research. “The approval of Vyvanse provides physicians and patients with an effective option to help curb episodes of binge eating.”

Vyvanse was reviewed under the FDA’s priority review program, which provides for an expedited review of drugs that are intended to treat a serious disease or condition and may provide a significant improvement over available therapy.

The efficacy of Vyvanse in treating binge-eating disorder was shown in two clinical studies that included 724 adults with moderate-to-severe binge-eating disorder. In the studies, participants taking Vyvanse experienced a decrease in the number of binge eating days per week and had fewer obsessive-compulsive binge eating behaviors compared to those on the inactive pill (placebo).

Vyvanse is dispensed with a Medication Guide for patients, which provides important information about the medication’s use and risks. The most serious risks include psychiatric problems and heart complications, including sudden death in people who have heart problems or heart defects, and stroke and heart attack in adults. Central nervous system stimulants, like Vyvanse, may cause psychotic or manic symptoms, such as hallucinations, delusional thinking, or mania, even in individuals without a prior history of psychotic illness.  (MAKE ANYONE LOSE THEIR APPETITE)  SO SICK YOU CANT EAT ANYTHING!

The most common side effects reported by people taking Vyvanse in the clinical trials included dry mouth, sleeplessness (insomnia), increased heart rate, jittery feelings, constipation, and anxiety.

Vyvanse is not approved for, or recommended for, weight loss. Its efficacy for weight loss has not been studied.

Vyvanse was approved in 2007 as a once-daily medication to treat attention deficit hyperactivity disorder in patients ages 6 and older. Vyvanse is a Schedule II controlled substance because it has high potential for abuse, with use potentially leading to dependence.

Vyvanse is marketed by Shire U.S., Inc., based in Wayne, Pennsylvania.

Source: FDA

Posted: January 2015

[ang]

Originally passed for ADHD...............  poor kids................Anyhow....So they found, that drugged up kids stopped eating. Wow, great one, lets market it it to stop people eating.  So lets create a new name,  over eating disorder, nah, eating isn't a disorder. And sounds a bit politically incorrect, as some people enjoy eating?  Getting a bit into bad territory, like fat disorder,  not correct, not acceptable.   Eating disorder......  That will be the next new disorder....  but better start with... how about  "Binge Eating "".............  sounds good, sounds real serious, and sounds good with the word disorder tacked to it. Binge Eating Disorder.... never heard of that one, must have invented this BED,  need acronymn for this new "disease", Binge Eating Disorder., because they new this drug fixes it, all those non-binge eating kids....imagine, kids refusing lollies, and heaps of chocolate?  apparently wonderful???....  I prefer to call it POWS  ""pigging out when stressed"",  or perhaps we all still have a little bit of kid, still inside us. Never heard of anyone dying or getting seriously injured, or unable to work because they got POWS or BED......no more chocolate binges! ...these drug companies are saving us all from ourselves?  Praise the lord?

 But read the side effects, and these innocent fellow lambs going to the slaughter, (I believe that the psych meds were perfectly safe too....  silly me!).  Or how would they have got passed.  Anyhow what gp is going to say you are taking a drug, that messed up, or sorts out, your brain?  No, this is a nice lolly perfectly non addictive, and safe (or how would it have got passed?)....Well if this amphetamine got passed, for pigging out now and again, the world really is crazy, and not due to the ones that have "labels".

The most serious risks include psychiatric problems and heart complications, including sudden death in people who have heart problems or heart defects, and stroke and heart attack in adults. Central nervous system stimulants, like Vyvanse, may cause psychotic or manic symptoms, such as hallucinations, delusional thinking, or mania, even in individuals without a prior history of psychotic illness.

I wonder if the gps point all this out, to the poor lady who pigs out on chocolate when stressed? And they say that the risk of the "disease"outweights the "risks of the medication".. You gotta be kiddin me?

So to stop someone sneaking the the fridge, when feeling stressed, now we have people addicted, suddenly dying, and of course now have a psychiatric label.......... that they prescribe this stuff to kids is abhorrent enough, but to suddently realise it stops the kids eating, lets flog it as a diet pill, or the new medicated "health"environment. OMG?

[westcoast]

I recall a study about binge eaters. Instead of depriving them, the researchers filled their cupboards to the gills with all their favorite binge foods--a seemingly endless supply. Believe it or not, that reduced binge eating. I could kind of see why. When I have binged it is a minor binge like finishing the whole bag of chips or cookies. But when there are two hundred bags, you know you can't finish them all, so maybe you just stop when you feel full? Because you know you can have more later if you want it.

 

Anyway, Vyvanse for binge eaters is just going to give us a lot more diagnoses of psychosis and bipolar, and a lot more people arrested or in mental hospitals.

[dalsaan]

Ang,

 

this doesn't belong in the journal section which is for articles published in academic or scientific journals. All entries I the section also follow a particular format. I will move this to the media section. Please provide a link to the source of this item

 

Dalsaan

[westcoast]

This is how the nytimes reported it

http://www.nytimes.com/2015/02/25/business/shire-maker-of-binge-eating-drug-vyvanse-first-marketed-the-disease.html

[ang]

thanks Dalsaan.  Yes I can see what you mean West Coast.  As a kid, if I ever went away from home, I would always panic about there not being enough food.  At home, i never worried about it.  I do know some people when stressed, eat, and others, like myself, just dont eat.   I get so damn thin.  Causes dermatillomania  looked that one up, picking at your skin, gosh they got a big name for everything.  So stop binge eating start picking instead    and other things.  Poor kids on this for ADHD, when they already going thru the acne stage?  And grinding teeth.

 

thanks for the very informative reference westcoast :  quote

 

The F.D.A. expressly forbade Shire from promoting Vyvanse as an obesity drug, but some drug safety experts said they worried its weight-loss attributes could be attractive to people who habitually overeat. The company says about 80 percent of people with the disorder are overweight or obese. Weight loss and appetite suppression are a common side effect of amphetamines.

 

(And got passed as it is the only drug to treat binge eating disorder, new disorder that suddenly appeared in 2013?).  OMG?

[ang]

http://www.nytimes.com/2013/12/15/health/the-selling-of-attention-deficit-disorder.html?action=click&contentCollection=Business+Day&module=RelatedCoverage&region=Marginalia&pgtype=article

 

the selling of ADHD.  Guess which company?  Shire again, had a diet pill, think it got banned, but did have an effect on kids, ah, guess what???    how about inventing ADHD, brilliant, making millions. Now time to market adults as having ADHD......apparetnly prisons are full of ADHD adults?  

 

And also,  Now in reverse mode, if they  cant sell it as a diet pill (illegal)  they  invented binge eating disorder.   Binge Eating Disorder created 2013, their drug passed urgently 2014, same drug..... passed quickly, as it wait for it!!!!!!!!!!!!!!!       , was the only drug to treat the new disorder.

 

Parents in Australia get extra family payments, for disabled  children,  ie ADHD kids.  Schools get more money for teaching staff, if they have more ADHD kids, gosh this disease is just growing, everyone likes funding and extra money.  And if the kids get tablets, they sell well on the streets !  What a bonus!

[compsports]

I recall a study about binge eaters. Instead of depriving them, the researchers filled their cupboards to the gills with all their favorite binge foods--a seemingly endless supply. Believe it or not, that reduced binge eating. I could kind of see why. When I have binged it is a minor binge like finishing the whole bag of chips or cookies. But when there are two hundred bags, you know you can't finish them all, so maybe you just stop when you feel full? Because you know you can have more later if you want it.

 

Anyway, Vyvanse for binge eaters is just going to give us a lot more diagnoses of psychosis and bipolar, and a lot more people arrested or in mental hospitals.

WC, you're thinking of the approach by Carol Munter and Jane Hirshman, who wrote two books several years ago called "Overcoming Overeating" and "When Women Stop Hating Their Bodies".   By the way, I spent a week at their retreat several years ago and it was one of the highlights of my life.

 

Anyway, following their approach completely cured my binge eating problems.  Unfortunately, when I started psych meds, I completely got away from iy as I was pretty much eating in response to drug induced hunger.   But fortunately, because of what they had taught, I never had a relapse.

 

Quite a contrast to the drugging the problem away.   I am just speechless about  this issue.

[ang]

[ang]

http://www.reuters.c...E67M1VO20100823

Many drugs for U.S. kids tested in poor countries link above

 

Explosive’ Growth in Foreign Drug Testing Raises Ethical Questions

http://www.pbs.org/n...earch-overseas/

 

I posted a story from another country on here long ago where poor were paid to do drug testing... often testing more than one drug at a time to increase their earnings... not sure where that link would be today. 

[ang]

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm432543.htm

 

Vyvanse was reviewed under the FDA’s priority review program, which provides for an expedited review of drugs that are intended to treat a serious disease or condition and may provide a significant improvement over available therapy. 

The efficacy of Vyvanse in treating binge-eating disorder was shown in two clinical studies that included 724 adults with moderate-to-severe binge-eating disorder. In the studies, participants taking Vyvanse experienced a decrease in the number of binge eating days per week and had fewer obsessive-compulsive binge eating behaviors compared to those on the inactive pill (placebo).  

Vyvanse is dispensed with a Medication Guide for patients, which provides important information about the medication’s use and risks. 

The most serious risks include psychiatric problems and heart complications, including sudden death in people who have heart problems or heart defects, and stroke and heart attack in adults. Central nervous system stimulants, like Vyvanse, may cause psychotic or manic symptoms, such as hallucinations, delusional thinking, or mania, even in individuals without a prior history of psychotic illness.yvanse was reviewed under the FDA’s priority review program, which provides for an expedited review of drugs that are intended to treat a serious disease or condition and may provide a significant improvement over available therapy.

The efficacy of Vyvanse in treating binge-eating disorder was shown in two clinical studies that included 724 adults with moderate-to-severe binge-eating disorder. In the studies, participants taking Vyvanse experienced a decrease in the number of binge eating days per week and had fewer obsessive-compulsive binge eating behaviors compared to those on the inactive pill (placebo).  

 

A WORRY 724 people and all those side effects?  Hmm?  Now they only pig out once a fortnight instead of once a week, and a nice high to go with it!

[ang]

They seriously call pigging out once a week, a serious condition?  Yes if you pig out, ie overeat once a week, you are seriously mentally ill, apparently.  No more chocolate binges on a Saturday, watching a movie!

Of course it will be used by people wanting to diet, although it is not allowed for this purpose (got banned previously) as a diet drug.   It is an amphetamine, used for ADHD, and I never seen anyone fat on amphetamines.......     

I just dont get it, the FDA pass this rubbish, look at the side effects?  Next they will be marketing lead pills.

And of course for all of us on SSRIs and ADs  will be just another add on, as we all get fat on those pills.

[westcoast]

I for one will not take the lead pills or the mercury drops! Yes, this Vyvanse thing is scandalous. A bunch more people will emerge with bipolar of psychosis, more families and lives destroyed. Time to register surviving-vyvanse.org?

[ang]

http://www.nytimes.com/2004/05/04/health/has-the-romance-gone-was-it-the-drug.html