View Full Version : Health Canada allows Adderall XR back on the Canadian market


Imnapl
05-20-08, 12:10 AM
Is it possible for this to be made a sticky because it keeps being omitted from media reports?

News Release

2005-92
August 24, 2005
For immediate release
Health Canada allows Adderall XR® back on the Canadian market

OTTAWA - Health Canada will allow Shire BioChem Inc., the manufacturer of Adderall XR®, to resume sales of the drug on the Canadian market following the recommendation of an independent and external committee appointed under the Food and Drugs Act.
The committee, known as a New Drug Committee (NDC), reviewed the suspension of the sale of Adderall XR® , a drug used for the management of Attention Deficit Hyperactivity Disorder (ADHD). The suspension took place on February 9, 2005 due to safety information concerning possible sudden deaths, heart-related deaths, and strokes in children and adults taking regular recommended doses of Adderall® and Adderall XR®.
The NDC reviewed the information on which Health Canada based its decision earlier this year and concluded that the Department's actions were appropriate. The NDC made a number of recommendations in its review and Health Canada has accepted them all. The NDC's recommendations will be available on the Health Canada website in the coming days.
In line with the committee's recommendation, Health Canada has agreed to reinstate the marketing authorisation for Adderall XR® with a number of revisions to the Adderall XR labelling. In particular, labelling will be revised to include warnings against the use of Adderall XR in patients with structural heart abnormalities. Another warning will advise about the dangers of misusing amphetamines.
The committee also recommended that Shire BioChem Inc. distribute a letter to healthcare professionals to inform them about risks associated with use of the product. In addition, the committee recommended that the manufacturer support independent continuing medical education for Canadian physicians to reinforce their understanding of the issues around sudden/cardiac death in the pediatric population.
Also, in line with the committee's recommendations, Health Canada is committed to enhancing post-market surveillance of all stimulant drugs used in the management of Attention Deficit Hyperactivity Disorder. Specifically, Health Canada will request that Shire BioChem Inc. provide safety information to Health Canada on a regular basis.
Under Food and Drug Regulations, when a drug is withdrawn from the market under article C.08006 of the Food and Drug Act, as was the case with Adderall XR®, drug manufacturers have the option of requesting the appointment of a New Drug Committee to review Health Canada's decision. The committee was comprised of three independent experts in the areas of pediatric cardiology, pediatric development and behavioural problems, and pharmacoepidemiology.
Health Canada is advising patients to consult their physicians, who will be receiving additional information from Shire BioChem Inc., about use of the drug.
Adderall XR®, a central nervous system stimulant, was approved in Canada on January 23, 2004. Adderall®, the immediate-release form of the drug, has never been marketed in Canada.
Health Canada relies on the active participation of health care professionals in adverse reaction reporting programs. Cases 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
cadrmp@hc-sc.gc.ca
For other inquiries: please refer to contact information.
The AR Reporting Form (http://www.hc-sc.gc.ca/dhp-mps/medeff/report-declaration/form/ar-ei_form_e.html) and the AR Guidelines (http://www.hc-sc.gc.ca/dhp-mps/prodpharma/index_e.html) can be found on the Health Canada web site or in The Canadian Compendium of Pharmaceuticals and Specialties.
Note: Health Canada issued another advisory on this topic on February 9, 2005. To access this advisory, visit:
www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/2005/2005_01_e.html (http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2005/2005_01_e.html)

spunkysmum
12-21-08, 06:26 PM
LOL, I wish I had seen this yesterday, some bonehead on another site was trying to use Canada's banning of the drug as proof positive that it is a dangerous drug nobody should take.

Imnapl
12-22-08, 02:11 AM
That's why I like to do a search for current news before replying to a thread - things change quickly.

Late Boomer
01-08-09, 04:20 AM
I am mostly frustrated that Aderall IR or the generic version aren't available. Besides being cheaper I don't react well to extended release drugs in general. Does anyone know if you can order it by mail or online?

I have always heard of americans getting their prescription in Canada but never the other way around. Is it legal to import generic Adderall for personal use? Also it will probably be taxed.... oh ....around 100% of cost but I still want to investigate.

synthesis
04-11-09, 02:36 PM
I am also curious as to how I can continue receiving my prescription for Adderall IR. I am an American that will be attending graduate school in Vancouver, BC starting summer 2009.

Are there any other Americans on the forums that are prescribed Adderall IR/XR but are living in Canada? Any information on your experiences would be much appreciated.

ADHDeveloper
04-11-09, 02:56 PM
Adderall XR is allowed and legal in Canada. I think you cant simply walk in to a pharmacy with a prescription from your american doctor and get adderall xr here though. You might need to see a canadian doc / psychiatrist and get a prescription.

Your university (UBC ? ) has a health center so first thing I would do is get your medical files transfered over to them from your current doctor. Try doing that before getting to canada so its all there and ready for you when you get there.

Then go see the university health center doctors or psychiatrists and they will prescribe you the meds you need.

In the meanwhile I am sure with a valid prescription you can bring your adderall xr with you to canada to last you until you see a canadian doc and get a new prescription.

Atleast thats the theory :) I would check and double check with airlines and perhaps even the canadian immigration officials to see if its ok to bring prescribed adderall xr with you to canada on the way here.

synthesis
04-13-09, 01:19 AM
Thanks for the input. I appreciate it. I will actually be starting graduate school at SFU, but I am assuming that the process with be the same for SFU as it is for UBC.

What about Adderall IR? This is my current medication and I plan on bringing a months worth when I first arrive in Canada this June. I plan on going back down to the states a few times over the summer, and while I am down there I will pick up my Adderall IR prescription.

It looks like the IR version is not available in Canada. However, does that make it an issue if I bring my script from the states up to Vancouver? I am assuming that it should be okay. Don't know if it matters but I will be entering Canada by automobile.

I guess I will be forced to change from the IR to the XR?

Thanks again for the input! I am a newly diagnosed with ADHD as of last month, so everything in new for me.

ADHDeveloper
04-13-09, 07:12 PM
No worries. I am newly diagnosed myself but its been about 3 months for me now. SFU should have the same procedure as any other university. http://students.sfu.ca/health/ that link may have some info for you. Do consider emailing them and asking them about this as well. Generally university doctors are extremely helpful, much more so than the ones you find in public access clinics and emergency rooms.

IR is as far as I know not available in Canada. My doc had talked about giving me a dexedrine booster for evening, and I am guessing that is an IR med. It really depends on the doctor you get and what he / she thinks after discussing your case with you.

I don't think you should have problem bringing in a months supply of Adderall IR into Canada with a legal script but I would REALLY double check with the canadian immigration people. Considering the global political climate nowadays its always a good idea to err on the side of caution.

Since you are newly diagnosed, do you take Omega 3's?