14 deaths force halt to Adderall in Canada

FDA Says May Study Hyperactivity Drug Risk

FDA Says May Study Hyperactivity Drug Risk

Mon Feb 14, 2:43 PM ET Health - Reuters



LOS ANGELES (Reuters) - The U.S. Food and Drug Administration (news - web sites) has warned that people with heart problems should not take the hyperactivity drug Adderall, but studies may be done to see if it raises risk in others, a top official at the agency said on Thursday.


The FDA (news - web sites) is aware that children have died after taking the drug, but cannot tell whether the rate is higher than it is in the general population, said Dr. Robert Temple, director of the FDA's Office of Medical Policy.


"There is a background rate of sudden death in children," he said.


Canadian regulators on Thursday suspended sales of Adderall XR, a drug for attention deficit hyperactivity disorder made by Britain's Shire Pharmaceuticals Group Plc, after the company said 20 people taking the drug, including 12 children, had suddenly died between 1999 and 2003.


The U.S. FDA last September ordered Shire to add a warning to the drug's label indicating that it should not be given to people with structural heart defects, but has not taken further action.


"We were aware of these reports of sudden deaths ... what we concluded was that five of the cases involved people with evidence of heart disease," Temple said.


Another case involved a child with Type 1 diabetes, a couple of the children had toxic levels of the drug in their blood and one child was exercised in the heat "until he was half dead from that," the FDA official said.


Over the same time period, the FDA's reporting system logged seven sudden deaths of children taking other ADHD stimulants -- Concerta, sold by Johnson & Johnson and Ritalin (news - web sites), made by Novartis AG .


All three drugs are stimulants.


The rates of death -- Adderall has been prescribed for 700,000 Americans according to Shire -- are too low for a randomized clinical trial to detect, but the FDA is considering conducting epidemiological studies to determine risk, Temple said.


In addition, the agency may compare results from its reporting system for patients on Adderall, Concerta and Ritalin to results for patients taking Strattera, the first non-stimulant approved to treat hyperactivity.


Strattera is made by Eli Lilly .
 
It would completely ignorant to take a drug being prescribed to 700,000 people off the market because 10 people die from the usage, and even those 10 deaths can't be positively linked to the drug. Canada is probably taking it off the market because they have socialized public healthcare, and therefore the government is forced to provide people with amphetamine prescriptions for free. That puts them in an odd position, unlike the US where they allow us to be prescribed it, but don't pay for it directly (that's why mostly white, middle-upper class kids take them...insurance). I'm all for a wide availability and choice of medications and taking Adderall off the market will only hurt. I can't believe you guys wanting even MORE government restrictions on healthcare/prescription drugs.

I agree with Joystick: Amphetamines are some of the safest drugs on the market. Same for morphine and the related pain killers. Drugs with no immediate psychoactive effects tend to be worse for you (APAP vs. oxycodone), and that's why I would NEVER take any SSRI, SNRI, MAOI, or Straterra-type medications. They've been used for over 70 years, and have proven to be safe at LOW dosages (ie: not 40mg a day...which is a lot, regardless of what anyone here says). Adderall is the least safe, and does pose the most heart risks compared to Ritalin, Dexedrine, and Desoxyn. Adderall is 50% amphetamine (overall 25% levoamphetamine), which has the most peripheral effects. Dextroamphetamine is less dangerous for this reason. The ONLY reason Adderall is so popular is the patent issued in 1996, but it is one of the WORST amphetamine preparations ever produced. It used to be called "Obetrol" and was a diet pill. I used to be prescribed it for ADHD and the shit's terrible. It feels like your on a shitload of caffeine. That's why Benzedrine (amphetamine sulfate; 50%amphetamine) was taken off the market in the 1970's, along with Biphetamine (amphetamine/d-amphetamine resin). Adderall is the same thing, but not all -sulfate salts or a resin complex. This doesn't matter THAT much. Now that Straterra is out, the FDA is going to push it until it's found to be worse than amphetamines ever could be. Anyway you look at it, objectively, straight d-amphetamine is the safest thing out there for ADHD. It may not last as long, but neither does Adderall XR/IR. It's 4 hours of d-amphetamine effects and 4 more hours of l-amphetamine wearing off.

Ephedrine (synthesized in the 1920s) and PHP are both newer than amphetamine and methamphetamine (first synthesized in 1889 and 1919, respectively). They are also less safe, since they both have PERIPHERAL effects and these are what kill people. Excessive central nervous system stimulation makes you go crazy, but won't give you a heart attack. Both methamphetamine and amphetamine are synthetic, but ephedrine is semi-synthetic (extract of ephedra, just like cocaine is extract of coca). Amphetamine was actually discovered by accident when the Germans were trying to make ephedrine the first time.
 
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>>marketing schmarketing. Adderall works. Period. If you have ADD, adderall levels you out. If you don't have ADD, it tweaks you the fuck out. >>

I'm a tad bit skeptical about this.
You give anyone a low dose of amphetamine, and she will concentrate better. On the other hand, anecdotally, paradoxical effects from amphetamines (e.g., drowsiness, calming effects) are reportedly more common among ADD-diagnosed individuals.

ebola
np: squarepusher
 
They're fine, to an extent. It was only when dumbasses started abusing meth in gram increments that they got a bad name. Closely monitored doses are the key. If you ask me the current dosage table IS bullshit. The maximum dosage for Adderall is supposedly 60mg; It should be 30mg MAX in rare cases only. 60mg is waaay too much, even if it is the "all mighty XR", especially for young kids. Nobody should be taking that much every day, because the only reason would be due to tolerance. Bad doctors are the problem, because well-educated doctors know about drug holidays. Without them people end up tweaked out taking too many pills, and that's how they start causing problems. It's not like they're benzodiazepines or pain killers where you CAN'T go without them for a few days. Sure the person will be a little grouchy and tired, but that lasts three days max (a weekend). After a week of no Adderall they will have no tolerance and actually feel BETTER than they did on the medication. It's much safer than just throwing an extra 20mg onto the Rx each month. That only creates problems down the road. Don't blame Adderall, blame the stupid General Practictioners handing the stuff out like candy.
 
I would hope that they're not actually giving 60mg Adderall XRs to kids, Jesus Christ, no wonder they're dying.

I'm a 200lb man and I only take 20mg a day for ADHD (two 10mg IR doses spaced out over the day). I can't imagine what 60mg a day would do to a kid.

I used to be very skeptical of the ability of Adderall and other amphetamines to treat ADHD and other disorders. Then I actually tried it. Nothing has worked as well, and the drugs that a dumbass doctor put me on before Adderall almost killed me (needless to say, I no longer see that doctor, and my college health services no longer allows her to write prescriptions). I know that for most people, amphetamines are stimulants, but for me, they make me more sedated and focused. I've actually found myself taking naps after taking it, and it's actually kinda ironic that there are times when I've fallen asleep faster with amphetamines than without, but I guess I'm just wierd. I think that part of the reason for putting levoamphetamine in the adderall mixture along with d-amphetamine (and I don't know where you got that 50% amphetamine, it's 75% d-amphetamine and 25% l-amphetamine broken down into different salts) was probably for people like me who find it sedating and need the peripheral stimulation, otherwise it's almost worthless for me.

My mom actually called me up the day this story broke to say that she'd heard something about Adderall being pulled in Canada and wanted to make sure that I'd talked to my doctors about it. I'd actually just met with my doctor the day before, so it wasn't a huge issue, and I pointed out that yes, when if you give amphetamines to people with heart conditions, they can die. If I'd had a heart condition or high blood pressure, my doctor would have been intelligent and put me on something else.

I can't imagine that they'd actually pull it in the US. Too much money and other interests involved, not to mention the fact that the only alternatives are Ritalin (which has its own problems) and non-stimulant drugs like Wellbutrin (which almost killed me) and Straterra (which has only been on the market about as long as Vioxx was), or having people going out and buying street speed for medical reasons. Having Adderall on the shelf obviates the need to the kind of conundrums that we've had with medical marijuana. By having a regulated form of the stuff available, it creates a pretty clear dichotomy between Adderall and street drugs...not that there's any real difference from a chemical standpoint, but it allows us to differentiate from medical and recreational use.
 
JTMarlin said:
: Amphetamines are some of the safest drugs on the market. Same for morphine and the related pain killers. ever could be. Anyway you look at it, objectively, straight d-amphetamine is the safest thing out there for ADHD. It may not last as long, but neither does Adderall XR/IR. It's 4 hours of d-amphetamine effects and 4 more hours of l-amphetamine wearing off.

Ephedrine.
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daily use of ADD/ amp meds is not safe and neurotoxic in the long run. ephedra was banned after ~100 indirect deaths attributed to it over several decades. There is no reason to use amp on a daily basis. look for better "natural" cures. who wants to put there 7yo on ritalin? 7 million do. poison.
 
JTMarlin said:
Canada is probably taking it off the market because they have socialized public healthcare, and therefore the government is forced to provide people with amphetamine prescriptions for free. That puts them in an odd position, unlike the US where they allow us to be prescribed it, but don't pay for it directly (that's why mostly white, middle-upper class kids take them...insurance). .
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You are completely wrong, health care services are free in Canada, but no one provides prescriptions or medications for FREE. You still have to pay for your own meds. This has NOTHING to do with federal health care funding.

8)
 
I completely agree that 30mg of amphetamine (or d-amphetamine or methamphetamine) is TOO much, and 60mg is an OVERDOSE.

I've known 18 year old girls who were prescribed 60mg of adderall (non XR) per day, she of course knew that was too much so limited herself to 30mg and considered the rest "profit" (sadly, she stopped taking it due to panic attacks and social phobia, and is now unsuccessfully self-medicating her ADD with alcohol).

I personally began with ritalin as a kid (20mg SR per day) then refused to take it as soon as I got old enough to realise it was causing the miserable feeling I was having (that I now recognize as anxiety). As an adult I realised I needed something to put up with grueling 8am classes and 10 hour work days, so my doctor and I agreed that I'd start with 20mg of adderall and titrate from there... which over the course of 2 years became 2.5mg of dexedrine per day (dexedrine had much fewer of the cardiovascular, sweating and vasoconstriction effects which I found so debilitating), then provigil, before I quit using stimulants altogether because the side effects were hurting my productivity as much as the stimulation was helping (and it DOES help). A year later I was back in a "structured work environment" and started back on dexedrine, then switched to my present ADD regimen of 2.5 - 5mg of D-methamphetamine (legally prescribed) which seems to have the fewest side effects of any stimulant I've tried.

daily use of ADD/ amp meds is not safe and neurotoxic in the long run
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Can you please cite your source for this information? As somebody who enjoys learning about pharmacology and plans to use stimulants for as long as it is neccessary for me to take them, I try to learn all of the information I can on this subject. In particular I've focused much of my research on the mechanism of toxicity, which with amphetamine seems only to exist with massive overdoses, and with methamphetamine is mostly due to oxidative stress (free hydroxyl radicals), although at 5mg/day it seems no worse than a day in the sun or breathing car exhaust while driving an hour on the freeway. I am personally doing all I can to protect myself from free-radical toxicity (conjectured to be a major source of aging), including taking 1g of Vitamin C and 180mg of R-Alpha Lipoic Acid, 500mg of Acetyl-L-Carnitine, a Mens multi-vitamin, magnesium, zinc and selenium each day. Please note that it is NOT nearly as safe to take either amphetamine or methamphetamine in larger doses (such as 100mg per day) for ANY length of time, due to cardiotoxicity, stroke risk, and neurotoxicity due to high body temperature, dehydration or excessively high or low dopamine concentrations (not to mention dangerous behavior, shady people/dealers and legal risk).

As an interesting aside, I once weighed a "shit-pipe" before and after it was packed with a typical 2-person "bowl" of meth, and it weighed 68mg more after being packed, then lost around 10-12mg after each of the first 5 "hits" taken from it (I wasn't doing the smoking). I've also seen people spend at least 3 hours "de-resinating" their pipe trying to get that last 2mg coated on the inside...

Nearly kid with childhood ADHD who is prescribed a stimulant still needs to EXCERSIZE in school, P.E. is a mandatory requirement from elementary school through high school, and sports are HUGELY popular in American culture (I myself played 3 "official" school sports in high school, and several more athletic extra-curricular activities). In this world where the jock gets the girl, performance expectations are constantly increasing (childhood workaholism exists), and kids are being prescribed 60mg of amphetamine, it is NO surprise that SOME children are dropping like Iraqi civilians.
 
Just to give a plug for my country, Canada:

You are completely wrong, health care services are free in Canada, but no one provides prescriptions or medications for FREE.
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Actually, in the provinces there are prescription drug plans. In Ontario, for example, the government pays for any prescription drugs above *4%* of your annual income. It's an amazing system - I hope it can last!

Hospitals can also provide a 30 day supply of essential (asthma or similar) medication for free if the patient cannot pay for it. (this is a little known benefit - and hopefully is not abused too much).

On the theory of amphetamine XR being taken off the market for cost concerns, I don't think that is the reason at all. There are MANY other drugs that are popular and far more expensive than Amphetamine XR. In addition, simply taking one amphetamine off the market would simply shift the cost onto other drugs.
 
^^ The meds above 4% of your income you speak of could be deducted from your income tax , but you still have to pay for them. And if you are in a hospital yes you do get medication for free because it is considered a part of your treatment.

Anyway, this is not the issue for Health Canada, remember that Canada was also one of the 1st countires that blew the whistle and implemented warnings for SSRI's and suicides (esp for children)
 
The difference is that all these drugs (Paxil, Zoloft, etc...) are NEW. Amphetamines aren't. There's not much left to be understood about them, seeing as they're 70 years old. Read Lester Grinspoon's book about them, and that's 33 years old, which tells about all this "news". People just forget too easily. Adderall will NEVER go off the market in the US. It's too much of a money maker. The only reason ADHD is diagnosed so often lately is because it's the only thing that amphetamines can be prescribed for (not many narcoleptics and fat people get them, they don't count). Back when they were able to be Rx'ed for depression, weight loss, and "extra energy" ADHD didn't exist for the most part (or DBS - Dysfunctional Brain Syndrom as it was called). Why? There wasn't a reason for it to exist. For most of the 20th century amphetamine was a revolutionary chemical and then drug laws made them impossible to be used in medicine for a few decades (1970's and 80's amphetamines all but disappeared, while Shitalin took over). ADHD is a reason to prescribe something that's a great chemical but otherwise socially unacceptable to take just because you like it.

Yes, some kids can't pay attention...so what? No one is perfect. Get over it. I was 100% "ADHD" when I was a kid, but my parents knew it was bullshit. They saw my friends all zombied out on the Ritalin their parents fed them because they couldn't control their kids. Bad parenting causes these "symptoms", and the need for a reason to market amphetamines creates the disease that has those symptoms. Covering them up only makes people into failures (for the most part) in the long-term, while being able to display them usually results in being professionally and socially successful (Einstein, Howard Hughes, Bill Gates, etc... all would be "ADHD" today).
 
why didnt they think of this before....these amps have been around for decades...remeber benzidrine inhalors...anyone?

however, with the mass dosing of school children (isn't speed considered a hard drug?), i guess things have changed.

i jus wish they knew about these things when i was in school. my whole life could have been different. i slipped through the cracks becuz of ADD. i was labeled a failure. now i know better. where's my compensation, huh.

maybe i could have avoided a decade and a half of addiction.

jus give me a fucking script for these and ill be happy.

in my dreams. reality sucks. reality kills.

im gonna try the strattera, if i can ever afford the fucking doctor. i made it this far, so im alright. thats what they think. fuck them...the whole medical establishment.

ok...im fine now...sorry.

jus give more speed to more school kids and society will be peachy. it seems fucking sick to me. nurture the difference. teach different to different kids. i learn jus fine, but its gotta be my way. alot of chaos. it all works out tho. ADD kids are special, they should be glorified, not over medicated.

this has got to be one of the more fucked aspects in the invisible war.
 
Do you think they will pull it off the market in the U.S. too??? I'm hoping everyone with the power to make this decision is making too much money from adderall sales to take it off the market. Plus, what would 700,000 people do all of a sudden without their medication? Are less people in Canada prescribed it, so that its not such a big deal to discontinue use?
 
The deaths certainly warrent more investigation. Like doses, what health problems these people had that might have contributed to their deaths, etc.

As someone who has ADD, I took Adderal XR. I had to go off it because it made my heart beat eradicly. Then again, I have a BIG history of heart disease/high blook pressure in my family. Maybe that's a factor. But the meds did help me concentrate and get things accomplished. So I was sad to have to go off them.
 
About 700,000 people take Adderall XR in the United States, with about 300,000 more using Adderall, Shire spokesman Matthew Cabrey said Wednesday. Shire reported $140 million in U.S. sales of the drugs in the third quarter of 2004.

The drug is made by Shire Pharmaceuticals Group PLC, based in Basingstoke, England, and is sold in Canada and the United States. A related immediate-release form of the drug, sold simply as Adderall, is sold in the United States but has not been approved for sale in Canada, where 11,000 patients are prescribed Adderall XR. Canadian officials approved that drug in January 2004.


I jsut read this ^^ on this web site http://www.intelihealth.com/IH/ihtIH/WSIHW000/8271/8014/412635.html

11,000 people compared to 700,000 (or even 1,000,000 counting IR) is a huge difference, not to mention no one wants to give up making that kind of cash, so I think our adderall in the states is safe, right?

just answering my own question here :)

peace%)
 
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