Advisory
2005-01
February 9, 2005
For immediate release
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: 866 234-2345
Fax: 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.
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Media Inquiries:
Media Relations
Health Canada
(613) 957-2983
Public Inquiries:
(613) 957-2991
Note: Health Canada issued a news release on this topic on August 24, 2005. To access this news
release, visit:
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