Adderall XR Back in Canada

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Back in February this was taken off the market.......

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...

http://www.hc-sc.gc.ca/ahc-asc/media/nr-cp/2005/2005_92_e.html

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From Feb 2005

Date: Thu, 10 Feb 2005 20:46:39 +0000

Subject: [active_people] Canada - ADHD drug - Adderall XR Suspended

Reply-active_people

2005-01

February 9, 2005

For immediate release

Advisory

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

cadrmp@...

For other inquiries: please refer to contact information.

The AR Reporting Form and the AR Guidelines can be found on the Health

Canada web site or in The Canadian Compendium of Pharmaceuticals and

Specialties.

www.hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/adverse_e.html

www.hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/adr_guideline_e.html

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Sheri Nakken, R.N., MA, Classical Homeopath

http://www.nccn.net/~wwithin/vaccine.htm