FDA calls for strong warning labels on ADHD Drugs

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ADHD drugs must now carry warning labels that state that these drugs may cause suppression of growth, psychosis, aggression and serious cardiovascular side effects, says the Food and Drug Administration (FDA).

In it's August 22 article, "FDA Orders Strong Warning on Stimulants," the New York Times reports that this recent warning "significantly strengthen the risk information already on these drugs..... The warnings state in part, 'Sudden deaths, strokes and myocardial infaction have been reported in adults taking stimulant drugs at usual doses.'" These warnings caution about an increased risk of strokes and heart attacks and "come after scattered reports of children dropping dead suddenly while taking the drugs."

"It's appropriately worded," says Steven Nissen, president of the American College of Cardiology and chairman of cardiology at the Cleveland Clinic regarding the warnings.

He says, "It basically lets physicians and patients know that these drugs to have serious cardiovascular side effects."

In February, an FDA advisory committee strongly recommended that the FDA require all ADHD drugs come with a black box warning, the FDA's strictest warning, exposing the risk of drug-induced heart attack, stroke and sudden death. In March, a different committee convened and recommended additional warnings about psychological side effects.

Earlier this year, Australia launched an urgent investigation into the safety of ADHD drugs following 400 adverse reactions involving children as young as three. The United Nations' Committee on the Rights of the Child reported in September 2005 that it was concerned that ADHD and ADD "are being misdiagnosed and therefore psycho-stimulant drugs are being over-prescribed, despite the growing evidence of the harmful effects of these drugs." In the last year alone, there have been ten international warnings that ADHD drugs can cause suicide, psychosis, hallucinations and mania. Four of these warnings specifically address the potentially fatal cardiovascular risks of ADHD drugs.

Antidepressants received 12 international warnings which include suicide, addiction, homicidal ideation, liver damage and heart attacks. Five of these international warnings on antidepressants warn about the risks to pregnant women and their newborn babies. They show the risks of taking antidepressants during pregnancy are drug dependence for the mother as well as birth defects, heart malformation or a fatal lung condition in the newborn.
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Aug 26/2006
http://www.louisianaweekly.com/weekly/news/articlegate.pl?20060828b
 
hopefully this will make parents think twice before giving there children some pretty powerful drugs. somehow i doubt it though.
 
We should warn people about drugs they feed to their kids?

damn its like someone in the FDA just stopped having a stroke.
 
i recon ritalin and dex strunted my growth..
i only started in year 11
 
Giving a cocktail of amphetamines to a three yr old!!?? What the fuck. Since when does a three yr olds learning capacity matter? I mean what can you really teach a three yr old in an academic setting? What, was your kid not coloring between the lines!

As many of you will remember, the learning capacity of small children matters enough for the US to subsidize these drugs to the tune of 400/month for the parents and 400/month for the pharm learning centers (public schools). Someone come up with a better example of fascism.
 
The sad part is these effects were being talked about since the 70's when they started dosing the difficult kids with them.
 
remember people if your parents are too lazy to deal with your behaviors propely then you need to be prescribed mind altering drugs, its pretty much THE LAW
 
although i do not support further restriction for drugs, i do feel that warning labels that describe what the drug can do are necessary, especially when were giving drugs like this to our children..

many parents and guardians give their children amphetamines for adhd without knowing that in a few years it is almost guarenteed they will be abusing it or selling it.

every person i know from my middle/high school on the drug was corrupted into selling or abusing it within months.. even weeks. honestly after typing this im not sure what my arugment is due to the fact i dont care if kids abuse the drugs... i guess i am thinking in the interests of parents trying to keep their kids off drugs here

my question is how can parents tell their kids not to do drugs and feed them amphetamines at the same time?
 
I have a love/Hate relationship with amphetamines. Been taking dex for a few years and overall it's been great. For me, the pro's outweigh the cons by far.

If I go to school and try to succeed and do well without any amphetamines, I'm a mess and can't funtion very well.

Amphetamines at the right dose actually helps people learn better and retain more information. It is a performance enhancer mentally and physically. I am really scattered and disorganized without them. I think I would miss ALOT of important information if I never took amphetamines.

Now I started around 14 or so and am 21 now.

The hate relationship comes when you give amps to lil kids. I'm still undecided with that whether it's good or bad. I always feel sorry when I see 5 year olds on amps. I think you are too young.

An age limit should be made for amphetamines....like 13 or something.......just my thoughts.........ok, back to seinfield.
 
I love how the majority of our nation thinks that if something is marketed by pharmaceutical companies, and prescribed by doctors then it must be safe and risk-free. Yet when some sort of illegal substance (whose effects are often mimicked by many RX drugs) is brought up, people are mortified by this sociological taboo. It shouldnt be any suprise that taking amphetamine (adderall) daily even when used as recommended by our doctors WILL cause heart and psychological problems. People need to start taking a more realistic, and responsible outlook on what they are using, and weigh the pros against the cons. In many cases the benefits received from the drug usage will outweigh its risks so its worth the gamble. I'm just sick of consumer whores who take whatever their doctors prescribe them without having any idea whats its doing to them, and then come back complaining with their lawyers about how they had a heart attack after being prescribed adderall for 20 years.

I'm by no means against anyone using these or any other substances because they can be very helpful, but I wish they were more aware that there are always going to be side effects.
 
Yeah I have always found it amazing that they pump little kids full of amphetamines. But then again, I am someone who does not have ADHD. Apparently the amphetamines will affect someone who does have ADHD much differently. Is this really true though? I also have the ability to focus while on stimulants such as amphetamines, but it comes along with all the other nasty amped-out, edgy, paranoid as fuck feelings that I hate. I don't know, because of my lack of ADHD it may make me unfit to truly know how one with ADHD would feel when under the influence of these drugs, but either way, who the hell thought of giving speed to little kids who were already hyper to begin with?
 
It stunted my growth. I'm older now, but I was prescribed Ritalin for 10 years, starting when I was five.

I took myself off the shit and discovered the joys of smoking pot. Good times
 
Beware... long post. I've written a few 'editorials' on the subject in the past, and my opinion has varied wildly with time.

I personally have been prescribed Adderall/Dexedrine for the past few years... I'm 25 now. I too would say that the positives outweigh the negatives, but there's no question that they take a physiological toll on me at times.

On a related note, since I essentially completed all of my education without stimulants, I have the perspective of having evaluated my capabilities with and without them... While I was always the type of student that *really* struggled with any sort of work that was not mentally stimulating enough and required me to force myself to focus on it for extended periods of time, I managed to get through it. Not only that, I'd say that I was better at focusing without stimulants than I am now. Call it a psychological dependency or a physiological dependency-- it doesn't really matter... It's definitely still a dependency on some level. I have no problem going without them for days at a time if I don't need to work... in fact, much of the time I prefer it... but I find myself increasingly useless without them.

Would I go back and change the fact that I started taking them if I could? No, because my OVERALL capacity for work is *definitely* greater when I am on them. The difference is distinct enough that I feel I can safely say that I would not have gotten anywhere close to as far with my career as I have without them. I am less stressed out, more responsible, and generally more emotionally stable when I take them regularly as prescribed. I am also more likely to feel physically exhausted, more prone to elevated heartrate, mildly but chronically dehydrated, and occasionally experience night sweats that I never did beforehand. But I'm definitely happier overall.

Double edged sword? Yes.

Do I think it's acceptable to be giving them to hyperactive children during the critical phases of their lives in which they are still physically developing? Well, in the vast majority of cases, probably yes. Is it a risky proposition? Undoubtedly. As with any potent psychoactive, there is going to be a subset of the population that reacts in an atypically negative way. But I know numerous individuals that have been on them for essentially their entire lives and have developed into relatively normal, responsible, and highly intelligent and functional people.

As my psychiatrist often says- it's generally better to be taking medication and live functionally than to not be taking medication and live disfunctionally... Some children genuinely respond so profoundly to stimulant therapy that the drugs arguably raise their overall potential for success from downright grim to well above average. I've observed it in the children of some family friends and I can't deny the dramatic, night and day improvements in some cases. Imagine a child that is so hyperactive that he literally vocalized his discontent with being unable to focus on anything ("mommy, I think too much, and I can't stop.") at the age of 7, but after being put on ritalin suddenly developed a healthy interest in books, music lessons, and artwork, not to mention actually looking forward to going to school, and within a year, he was moved from the "learning disabled" classes to accelerated ones. Most importantly, HE was happy about it. When asked if he wanted to stop taking ritalin, the answer was an emphatic no. And of course not... Would you want to go back to having nothing but the compulsion to break crayons and rip pages out of books when they were handed to you if you'd made that kind of improvement?

Some children are simply in such dire physiological need of physical stimulation that they are forced to seek it by any means necessary. Stimulants curb that hunger and leave them with the mental capacity to devote constructively to things that probably interested them beforehand, but they simply found themselves incapable of embracing.

One could argue that a child like that is being given an opportunity to develop his mind in ways that will prove invaluable later in life that he literally would have had no chance of achieving naturally. Yes, there are inherent risks, but if the drug truly can make the difference between a tumultuous and potentially depression-riddled future, and a stable, ambitious, and educated one... I can see a definite argument for why some children recieve these drugs.

As for the psychiatrists that give ritalin to a child the first time he/she acts out in class... that's just irresponsible psychiatry, and it would be a shame if the widespread use of stimulants in fairly mild cases leads to eliminating the option of prescribing them to the kids that can truly benefit from them.

There's no simple answer. I can't argue with the warning labels, however, as long as the proper statistical perspective is provided. The severe side effects are outliers, and a lot of ordinary people don't interpret them that way. The fact of the matter is, the vast majority of people that take stimulants at prescribed doses for even decades at a time emerge relatively unscathed. People deserve to know that fact just as much as they deserve to know the associated risks.
 
^^^
I agree, especially the part about being given an opporunity "to develop the mind ind ways that will prove invaluable later in life."

However, stimulants are addictive and sometimes the withdrawal symptoms can fool people in to thinking they are useless without the drug. If they would just spend 2 weeks off the drug, they would find that they are more functional than before.

I think that people can "learn" to be more focused by taking stimulants for a while and then stopping at some point. A lot of things in life are simply habitual - "use it or lose it."

If you use stimulants responsibly and stay focused on your self-development...I think they can be a good thing.
 
Thank you for this thread, it really strikes a chord with me.

I was prescribed ritalin when I was 11 or 12. I didn't need it either - I didn't have ADD, I was just an extraordinarily lazy child (hell I'm still extraordinarily lazy). After going through 6 years of ritalin to adderall to dexedrine (when the adderall factory exploded, does anyone remember that) to back to adderall, I found myself in quite the fucked up mental state. First thing else they gave me was an antidepressant which made me not want to kill myself but turned me into a zombie. Then came the long psychiatric tests and the prescriptions for mood stabilizers and anti-psychotics. Somehow I managed to get an 8 day stay at a mental hospital thrown in there somewhere.

Then when I turned 18 I moved far away as soon as I graduated high school and stopped using all the rx drugs I was supposed to take. What did I find out? I was normal to begin with. Sure I may be a bit lazy, but at least I'm sane.

My growth has definitely been adversely affected - according to genetics I should be at least 2 inches taller (unless I have a recessive gene I don't know about). When I was a younger child I used to run all the time - then they put me on the amphetamines and I stopped running and doing any other strenuous physical activity because I didn't enjoy the feeling of my heart being about to explode.

I'm considering sending my parents an email with this article linked to it, and a note saying 'thanks' =\



And to nexigram, I have found in my experience that amphetamines balance out hyperactivity because at low (read: medicinal) dosages they actually act as sedatives.
 
However, stimulants are addictive and sometimes the withdrawal symptoms can fool people in to thinking they are useless without the drug. If they would just spend 2 weeks off the drug, they would find that they are more functional than before.

This is a definite possibility... The degree of success will probably vary from person to person, though.

And to nexigram, I have found in my experience that amphetamines balance out hyperactivity because at low (read: medicinal) dosages they actually act as sedatives.

Is this actually true? I personally have found that my body does seem to calm down when I take my first dose of the day, but my psychiatrist explained this to me as satisfying the mild physical dependence that occurs when you regularly take medicinal doses... I don't think there's anything about low doses that actually consistantly sedates the nervous system, even if they may result in a tranquilizing effect.

From a general standpoint, I think they balance out hyperactivity because of their dopaminergic properties, as dopamine levels are definitely related to one's ability to focus... But I really don't know enough about the subject to have much to back up this guess. :)
 
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