New cautions regarding
rare heart-related risks for all ADHD drugs: Health
Canada
May 26, 2006
Health Canada has
revised the prescribing and patient information
for all drugs used for the management of ADHD
(Attention Deficit Hyperactivity Disorder), and
advises Canadians not to use them if they have
high blood pressure, heart disease or abnormalities,
hardening of the arteries or an overactive thyroid
gland.
The new prescribing and patient
information applies to both adults and children.
Standardized labeling that identifies
risk factors for rare heart-related side effects,
and new recommendations to physicians have been
added to the prescribing information for the following
drugs, and for any products containing these drugs:
| ADDERALL XR® |
mixed salts amphetamine extended-release |
| ATTENADE™ |
dextromethylphenidate [approved by Health
Canada, but the manufacturer has not marketed
in Canada] |
| BIPHENTIN® |
methylphenidate controlled release [approved
by Health Canada, but the manufacturer has
not marketed in Canada] |
| CONCERTAâ |
methylphenidate extended release |
| DEXEDRINE® |
dextroamphetamine |
| RITALIN® |
methylphenidate |
| RITALIN SR® |
(methylphenidate extended release) |
| STRATTERA® |
atomoxetine |
â Trademark used under licence
to Janssen-Ortho Inc.
ADHD drugs are generally safe and
provide benefits for Canadians and their treatment
of ADHD when used as directed. Decisions about
taking any of the drugs are best made in consultation
with a physician.
Before using these drugs, patients
should inform their doctor if they are involved
in strenuous exercise or activities, are using
other drugs for ADHD, have certain heart-related
conditions or have a family history of sudden
cardiac death. Health Canada stresses that patients
should not stop taking ADHD medication without
first consulting their doctors.
All ADHD drugs stimulate the heart
and blood vessels (cardiovascular system). The
effects are usually mild or moderate, but in some
patients, this stimulation may – in rare
cases – result in cardiac arrests, strokes
or sudden death.
Patients taking ADHD drugs should
consult with their physician if they have any
questions or concerns.
Health Canada continues to monitor
the safety of these drugs and Canadians will continue
to be informed if new concerns arise. For more
information, please see the Health Canada letter
to healthcare professionals regarding this issue.
To report a suspected adverse reaction
to ADHD drugs, please contact the Canadian Adverse
Drug Reaction Monitoring Program (CADRMP) of Health
Canada by one of the following methods:
Telephone: 866-234-2345
Facsimile: 866-678-6789
CADRMP
Marketed Health Products Directorate
Health Protection Building, Tunney's Pasture,
AL 0701C
Ottawa, ON
K1A 0K9
Email: cadrmp@hc-sc.gc.ca
Consumers requiring more information
about this advisory can contact Health Canada's
public enquiries line at (613) 957-2991, or toll
free at 1-866-225-0709.
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