14 deaths force halt to Adderall in Canada

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fruitfly

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Safety concerns have clouded the future of another blockbuster medication, this one a hyperactivity drug prescribed to 700,000 Americans, most of them children.

Health officials in Canada have suspended sales of Adderall XR, citing international reports of sudden deaths and strokes in children and adults.

Health Canada, the country's counterpart to the U.S. Food and Drug Administration, cited reports of 14 deaths in children and six in adults. The deaths were not associated with misuse of the drug. There also were 12 reports of stroke, two in children, according to Health Canada. It is unclear whether any of the deaths occurred in the U.S.

The FDA has access to the same international reports, but has declined to suspend sales or add warnings about the drug, which is used to treat Attention Deficit Hyperactivity Disorder. The FDA has consulted with Canadian authorities, but "does not feel any immediate changes are warranted," an FDA statement released yesterday said.

News about the drug has raised concerns among doctors who treat children with ADHD, a disorder that affects 3 percent to 5 percent of school-age children. Children with the ADHD can have short attention spans and difficulty concentrating. Many have learning disabilities.

"We've become reliant on these drugs," said Larry Diller, the author of two books on ADHD. "If used appropriately, these drugs can make a huge difference."

Critics of the FDA are criticizing the agency for not moving to suspend sales of Adderall. The agency is already under fire for not moving more quickly to take Vioxx, a best-selling painkiller, off the market. In October, Merck of Whitehouse Station pulled Vioxx off the market after a study found the drug doubled the risk of heart attack and stroke.

Critics are again pointing fingers at the FDA.

"Why is the American public entitled to less safety than Canadians?" asked Vera Hassner Sharav, president of the Alliance for Human Research Protection, a non-profit group based in New York. "If you've got these deaths and strokes, even in children, who generally don't get heart attacks and strokes, you should pull the drug off the market until the manufacturer can prove it's safe."

The watchdog group Public Citizen, another frequent critic of the FDA, said it will begin an immediate analysis of the international database of adverse events related not just to Adderall, but to similar drugs, such as Ritalin. Adderall is not on Public Citizen's list of dangerous drugs.

Larry Sasich, a pharmacist and research analyst at Public Citizen, said Adderall is an amphetamine that raises blood pressure and heart rate. "It is a plausible way in which this drug could harm people," Sasich said.

The maker of the drug, Shire Pharmaceuticals Group PLC, based in Basingstoke, England, said it strongly disagrees with conclusions drawn by Health Canada and is considering "responsive action."

It called the drug safe, and a statement released yesterday said it put a warning on the drug saying it should "generally not be used in children or adults with structural heart problems."
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14 deaths force halt to drug in Canada
Hyperactivity remedy called threat to kids

BY CAROL ANN CAMPBELL, Star-Ledger Staff
February 11, 2005

Link
 
Interesting indeed. I wonder why they're targeting Adderall XR alone, and not mentioning regular 'IR' Adderall at all? It seems to me that there would be MORE of a risk of such problems with the instant release formula...

...Unless, of course, the XR formula gives users/patients a 'false sense of safety' due to its seemingly less intense initial onset?

Hmm...I wonder if this will spread to the US?

Ez,

...Ad
 
AdInfinitum said:
I wonder why they're targeting Adderall XR alone, and not mentioning regular 'IR' Adderall at all? It seems to me that there would be MORE of a risk of such problems with the instant release formula...
Click to expand...

XR was the only form of Adderall that was ever approved for prescription here.



-crazyface
 
^^ i dont believe thats true. I know a few people i go to school with who are on IR. It is entirley possible that i missunderstood them (i do that often), so if you could give me info id appreciate that.
 
I saw this on the new news like a half hour ago. They are warning everyone who takes adderall, ritaline, dexedrine ect... to take it back to their doctors or somthing.....
 
not the amps..

it was about time someone noticed the whole amp thing, i mean, come on

im hoping the scope of this "news" stays narrow

but i dont think id bet on that, dang it
 
i think this speaks volumes about Canada's approach to drugs. We have looser laws regarding use and possesion and we are stricter towards dealers and producers. An overly potent and over prescribed drug being taken of the market is a good thing. It shows how we can see through the marketing.












-crazy
 
^^
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. Either way, it's meth by way of prescription... of course some people are going to have heart problems or strokes. The number of people that died as a result of taking this drug is miniscule compared to the number of people who benefit from this drug.
 
Lingo said:
^^
marketing schmarketing. The number of people that died as a result of taking this drug is miniscule compared to the number of people who benefit from this drug.
Click to expand...

I don't think the canadian gov is willing to take that chance.
There are other add medications available that do not cause the "sudden death syndrome" which you seem to disregard as a "side effect".

Kudos to canadian govt although that may get them in legal trouble with Shire under nafta agreement.
 
The exact same thing happened a while back here in the US first with phenylpropanolamine (PPA aka beta-hydroxyamphetamine) and then with ephedrine (one of the two isomers of N-methyl-beta-hydroxyamphetamine, with the other isomer being the still legal, though constantly more controlled, pseudoephedrine). PPA could be used in the manufacture of amphetamine or 4-methylaminorex, while ephedrine (and pseudoephedrine too aka Sudafed) could/can be likewise reduced to methamphetamine. However, ephedrine like cocaine is all natural and can be extracted from the Chinese herb ma huang; therefore, even methamphetamine is "semi-synthetic," as is LSD for that matter.

Apparently, a few people per several hundred thousands who take these medicines die suddenly of heart attacks or strokes. The number that this terrible side effect happens to is miniscule, but real. The same thing seems to happen with MDMA, another amphetamine, on very rare but real occassions. Sure, all amphetamines pose some risk, but that risk must be balanced with real and perceived benefits of these drugs.

After all, even aspirin kills people sometimes, but no one is clamoring to have it taken off the market, are they?

With the current pro-profits for big pharma and other big businesses of the current Republican White House at the moment, I doubt if W.'s minions will attempt to ban Adderall in the US. It is simply too profitable, but time will tell. Some actual, factual data would be nice to look at in this case as well. Amphetamines appear to me to possess a much greater safety profile than the narcotic analgesics, for example, as far as fatal overdosages go anyway. Another example is the relatively new, many so called, highly ineffective SSRI antidepressants. Studies have shown that they are completely ineffective at treating the depressionary phase of bipolar disorder, are thought to risk increased suicidal ideation, and can have debilitating sexual dysfunction side effects, but they are of course still on the market due to their profitability and popularity among health care prescribers (in large part also because they are uncontrolled and nonaddictive) and desperate consumers unwilling to try the forbidden pleasure drugs with which all of us here seem to be so familiar.

Interestingly enough, Wellbutrin aka bupropion aka N-tertiary-butyl-3-chlorophenylcathinone, which is a weakly stimulating phenethylamine derivative, has increased in popularity when compared with the traditional SSRIs and SNRIs. Part of this is because it does not share their sexual side effects and part of it is because it is an N-substituted, 3-chlorophenyl cathinone derivative of the amphetamines. Does Wellbutrin pose the same risk of sudden death via heart attack and stroke as does Adderrall, ephedrine and PPA? That too is an interesting question, but for starters, they should replace the N-tert-butyl functional group with and N-methyl one to make it even better IMO. Also, Wellbutrin could use a 4-chloro group as well IMO and may be better off without the benzylic ketone (Ph-CO-R) replaced with a methylene (Ph-CH2-R) unit as well. In other words, they should make 3,4-dichloromethamphetamine and see how well that sells, but no one listens to me a lot.

Another possible antidepressant and anti-PMS drug candidate is to simply smoke kind bud, is it not? I would like to see a study to determine if, as Willy Nelson claimed, that smoked, high quality marijuana is one of the best and only daily usable antidepressants, but there is not a lot of money to be made on a plant that anyone with a grow light and a closet can manufacture for themselves and which is non-patentable. However, my 1899 Merck Manual of Medical Information lists cannabis (and opium and cocaine) as treatments for many disorders, especially those relating to psychological or hormonal imbalances.

Bextra, Celebrex and Accutane are also under increasingly severe scrutiny by the FDA, according to a recent cover story in the newspaper, USA TODAY. Vioxx, Bextra and Celebrex are three relatively new non-steroidal anti-inflammatory drugs [NSAIDs] similar to aspirin, advil (ibuprofen), and aleve (naproxen sodium) but which work by inhibiting the cox-2 enzyme; they have been massively prescribed at outrageous prices here in the US since their introduction and were touted as being safer on the stomach than the earlier generation of NSAIDs. This assertion turned out not to be the case, and it was later found than Vioxx at least doubled the risk of cardiac and stroke in its regular users. That fact alone is, in my opinion, good reason to suspect the same of the other two as well. It is estimated that approximately 55,000 adults needlessly died from taking Vioxx on a daily basis, and that the drug companies kept this fact a secret for several years. All of this could have been avoided if the government had encouraged doctors to prescribe more of the very cheap, very effective hydrocodone/acetominophen combination found in Vicodin or Lortab, but heaven forbid!, some people might have enjoyed taking them too much. Furthermore, the cox-2 inhibitors were no more effective as analgesics than Advil or Aspirin.

Accutane [isotretinoin] OTOH, a drug remarkably good at clearing up stubborn acne vulgaris, is said to increase the risk of depression and suicide. Accutane does have many severe side effects, such as remarkably red, chapped lips which can lead to cheilosis as well dry, flaky skin, but I would venture that it is due to the severe acne which leads to the increased risk of depression and suicide in its users, not the Accutane itself.

My thesis, in short, is the following: as long as big drug companies come up with worthless, non-addictive new so-called "blockbuster" drugs at outrageous prices which must be taken every single day for the rest of one's forseeable future while the FDA tacitly approves or their practices, we are all headed on the road to Babylon.

Hillary Clinton was IMO right in her assessment of the US health care system. Doctors charge too much money for what they do, drug companies seek profits from new, to be taken every day drugs rather than cures and new vaccines, and hospitals routinely ruin the credit scores of countless uninsured Americans with their exorbitant bills, but I am digressing and will now shut up about all this.
 
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seems like like an overreaction to me 14 outta over 700,000, as these were internation deaths it would seem. Thats .002% of users. How many people have died from anestesia, I bet a lot more than one per 50,000 people put under. Chances are they had heart conditions or something, so their bodies couldnt handle amphets
 
Crazeee said:
I don't think the canadian gov is willing to take that chance.
There are other add medications available that do not cause the "sudden death syndrome" which you seem to disregard as a "side effect".
Click to expand...

Thank you for this reply... Even though I live in the U.S. where this drug is in fact legal..... I allways like to see people who have views in the sense where... "there are other alternatives out there" yes they might not be as readily avaible or as easy to use or obtain but they certainly don't cause side effects like the effects with the current ADD drugs..... Sure it may be miniscule the amount of deaths/heart attacks/ strokes versus the patients saved but it still has consequences for some as small as it may seem.... It's like going in to stitch up a cut finger and going into a coma........ I am not trying to condone current ADD drugs but I just cant sit here and listen to people say because those deaths are miniscule compared to the whole picture that these drugs are safe... People HAVE died... there is nothing miniscule about that..........
 
I wonder if they would consider banning alcohol or automobiles? Oh ya and some mothers die giving birth so maybe ban that too.
 
Lingo said:
^^
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. Either way, it's meth by way of prescription... of course some people are going to have heart problems or strokes. The number of people that died as a result of taking this drug is miniscule compared to the number of people who benefit from this drug.
Click to expand...

As much as I hate to say it, your totally right. I don't like the idea of my 12 year old nephew taking amphetamine but since he's begun taking adderall his grades have improved overall by a full grade letter in just about every class. Suddenly, he's one of the best students in some of his classes. What the drug has done for him is remarkable.
 
Beagle said:
As much as I hate to say it, your totally right. I don't like the idea of my 12 year old nephew taking amphetamine but since he's begun taking adderall his grades have improved overall by a full grade letter in just about every class. Suddenly, he's one of the best students in some of his classes. What the drug has done for him is remarkable.
Click to expand...

Probably so, but have you noticed your nephew with any type of problems sleeping or have you noticed him not eating much. I remember when I went to the doctor last year to get tested for ADD, he prescribed me XRs and he was telling my mom and me how well it has worked for his son.

Well, in order to be prescribed the drug, I have to go to the doctor every 2 months so they can check out my weight and ask me questions. Last time I was there, the doctor told me how he took his son off of it because his son was not getting any sleep and was not eating a thing.
 
Looks like US started paying attention...

Popular ADHD drug comes under greater scrutiny from U.S. parents

By Marilyn Elias, USA TODAY
Posted 2/13/2005

Parents whose children take Adderall XR for Attention-Deficit Hyperactivity Disorder (ADHD) face a dilemma this week: whether to let their kids stay on a medicine that could be unsafe when experts say there is a lack of long-term research to guide the decision.
The popular drug, which has been linked to 20 sudden deaths worldwide, mostly in children, was taken off the Canadian market Wednesday, sparking questions about whether kids in the USA should be using it.

The Food and Drug Administration issued a public health advisory on its Web site saying that the rate of sudden death for children on Adderall XR is no higher than for those not on the drug. But children with heart defects could be at higher risk.

Parents are making decisions about stimulants such as Adderall XR with few facts, says Julie Magno Zito, an epidemiologist at the University of Maryland. There are no good long-term studies of such medicines, she says. Rare side effects of a drug won't surface in short studies unless they include a huge number of kids, such as in a national HMO, and that kind of study hasn't been done on Adderall XR, Zito says.

About 700,000 children in the USA take Adderall XR, a timed-release stimulant, and 300,000 use Adderall, a version that often needs to be taken more than once a day, according to Shire Pharmaceuticals Group PLC, maker of the drug.

Parents whose kids are doing well on Adderall might consider a "wait and see" approach for now, says Baltimore pediatrician Richard Gorman. "School failure is a big issue for kids with ADHD, and these are very rare effects so far."

Of the 20 reports of sudden death, 12 were in the USA from 1999 to 2003, a time frame when 30 million prescriptions were written for the medicine, according to the FDA advisory.

More deaths could be reported in the wake of Canada's decision to pull the drug off shelves. On the other hand, the withdrawal could be rescinded if harmful effects are confirmed to be rare, Gorman says.

But parents should take a hard look at whether their children really need these medications, says University at Buffalo psychologist William Pelham, who has studied ADHD treatments.

Behavioral training programs for children, parents and teachers can lessen the need for drugs or make them unnecessary, he says. Programs are available through community mental health centers. And there's information on non-drug treatment at www.wings.buffalo.edu/adhd.

All children on ADHD drugs should get thorough medical exams, says Peg Nichols of Children and Adults with Attention-Deficit/Hyperactivity Disorder (CHADD), an advocacy and support group that receives some funding from drug companies, including Shire. "Parents need to be advocates for their kids and never fear asking questions," she says.

Linky
 
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