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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.
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
Media Inquiries:
Media Relations
Health Canada
(613) 957-2983
Public Inquiries:
(613) 957-2991
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