Adderall Taken off Canadian Market due to health concerns

Caverject

15+ Year Member
Aug 19, 2003
7,725
29
This is sort of scarry to think about, considering how many kids are on it. How does everyone else feel about it?

http://www.hc-sc.gc.ca/english/protection/warnings/2005/2005_01.html

Health Canada suspends the market authorization of ADDERALL XR® , a drug prescribed for Attention Deficit Hyperactivity Disorder (ADHD) in children


OTTAWA - Health Canada is informing Canadians that it has instructed Shire BioChem Inc., the manufacturer of ADDERALL XR® to withdraw the drug from the Canadian market. Health Canada has suspended the market authorization of the product due to safety information concerning the association of sudden deaths, heart-related deaths, and strokes in children and adults taking usual recommended doses of ADDERALL® and ADDERALL XR®. The immediate release form of ADDERALL® has never been marketed in Canada.


Health Canada is advising patients who are currently being treated with ADDERALL XR® to consult their physician immediately about use of the drug and selecting treatment alternatives.


Health Canada's decision comes as a result of a thorough review of safety information provided by the manufacturer, which indicated there were 20 international reports of sudden death in patients taking either ADDERALL® (sold in the United States, not in Canada) or ADDERALL XR® (sold in Canada). These deaths were not associated with overdose, misuse or abuse. Fourteen deaths occurred in children, and six deaths in adults. There were 12 reports of stroke, two of which occurred in children. None of the reported deaths or strokes occurred in Canada.


A preliminary review of safety data for the other related stimulants authorized for use in the treatment of ADHD in Canada has been conducted. In that review, the incidence of serious adverse reactions leading to death was higher in ADDERALL® and ADDERALL RX combined than in the other drugs of this class.


Health Canada has asked manufacturers of other related stimulants approved for the treatment of ADHD to provide a thorough review of their worldwide safety data. Information updates will be provided by Health Canada as they become available.


Patients taking drugs of the same class for the management of ADHD should NOT discontinue their medication, and should consult with their physician if they have any concerns or questions.


ADDERALL XR®, a Central Nervous System (CNS) stimulant, was approved in Canada on January 23, 2004 for the management of Attention Deficit Hyperactivity Disorder (ADHD) in children.


After having consulted with their physician, consumers should not flush unused drugs down the toilet or sink to avoid contaminating ground or municipal water systems but return any unused product to their pharmacy.


Health Canada has been in contact with Shire BioChem Inc., and will be monitoring the removal of this product from the Canadian market.


Health Canada relies on the active participation of health care professionals in adverse reaction reporting programs. Occurances of cardiac or other serious and/or unexpected adverse reactions in patients taking drugs of the same class should be reported to Health Canada at the following address:


Canadian Adverse Drug Reaction Monitoring Program (CADRMP)
Marketed Health Products Directorate
HEALTH CANADA
Address Locator: 0701C
OTTAWA, Ontario, K1A 0K9


Tel: (613) 957-0337 or
Fax: (613) 957-0335


To report an Adverse Reaction, consumers and health professionals may call toll-free:
Tel: 1 866 234-2345
Fax: 1 866 678-6789
[email protected]
 

ultracet

1K Member
10+ Year Member
15+ Year Member
Mar 4, 2004
1,938
7
Visit site
Status
Wow that's crazy... not too suprising though.. i would figure any CNS stimulants would be dangerous
 

reddirtgirl

Senior Member
10+ Year Member
Feb 8, 2005
181
0
www.radioparadise.com
Status
caveat: I don't have the pleasure of dealing w/ adhd kids on meds on a regular basis

In general, I think that given the long track record of levo & detro amphetamine (in adults), this is overreactive on the part of the canadian govt.

Suprisingly, USA Today had a pretty decent article about this news. If the pulling of adderall xr was based on the stats in that article, then the decision was perhaps ridiculous.

http://www.usatoday.com/news/health/2005-02-10-drug-withdrawal-usat_x.htm

"The 12 deaths out of 30 million prescriptions do not exceed what the FDA says it would expect to occur in a group that size. And the FDA said other factors also had to be considered: Five of the deaths occurred in patients with underlying heart defects. Another involved a child subjected to high temperatures, vigorous exercise and dehydration, said Robert Temple, an associate director for medical policy at the FDA."

I'm not sure if I'd be too keen on dosing my kid w/ adhd meds...

But adderall is a GREAT drug when used properly in adults. If I had to complain about any aspect of it, it'd be that the XR is way overpriced and is not that much better than the plain generic (based on plasma concentrations). Like alot of things in the media, there are plenty of horror stories implicating it negatively.... but you never hear about the good ones.
 

ultracet

1K Member
10+ Year Member
15+ Year Member
Mar 4, 2004
1,938
7
Visit site
Status
while it may just be media "hype" i'm not shocked that a CNS stimulant would be a dangerous drug.


I can already see the 1-800-Adderall if you or your child has taken Adderall or Adderall XR lawyer adds........
 
OP
Caverject

Caverject

15+ Year Member
Aug 19, 2003
7,725
29
This sounds like the same thing that is happening with the bull crap black box label warning on SSRI's
 

jemc2000

SDN Angel
7+ Year Member
15+ Year Member
Dec 13, 2003
563
0
55
Lakeland, FL
Visit site
Status
My daughter is on Adderall XR. She just started taking it in December. And yes, if you have never lived with someone with a.d.d., you have no idea the misery the child goes through. She can read at a level 3 grades above her own, but fails all her reading tests because she can't concentrate long enough to finish a test. It takes her 4 hours to do her homework (5th grade), because she gets so easily destracted. She has no friends, because she is a good kid who gets in a lot of trouble. So neither the "good" kids nor the "bad" kids want to play with her.

We did not jump into putting her on this lightly, it was pretty much a 6 year struggle that culminated into using meds. If anyone knows of any other treatments that have shown success, please PM me. I would be happy to discuss. Thanks.
 

ultracet

1K Member
10+ Year Member
15+ Year Member
Mar 4, 2004
1,938
7
Visit site
Status
I have a friend whose brother is ADHD and they unfortunately had to start him on meds when he was very very very young. he also happens to be epileptic

these meds do work and help improve quality of life for the children who need them

i currently don't really know of that much else out there. i'm also unsure of the amount of R and D going on in this area

its always a risk v benefit assessment when it comes to medication