feb 2005

Health Canada suspends the market authorization of ADDERALL XRŽ , 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 XRŽ 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 ADDERALLŽ and ADDERALL XRŽ. The
immediate release form of ADDERALLŽ has never been marketed in Canada.

Health Canada is advising patients who are currently being treated with
ADDERALL XRŽ 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 ADDERALLŽ
(sold in the United States, not in Canada) or ADDERALL XRŽ (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 ADDERALLŽ 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 XRŽ, 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@hc-sc.gc.ca

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.


 

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