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The Marketed Health Products Directorate (MHPD),
Therapeutic Products Directorate (TPD) and Biologics and Genetic
Therapies Directorate (BGTD) post safety alerts, public health advisories,
press releases and other notices from industry as a service to health
professionals, consumers, and other interested parties. Although
MHPD, TPD and BGTD approve therapeutic products, MHPD, TPD and BGTD
do not endorse either the product or the company. Any questions
regarding product information should be discussed with your health
professional.
This is duplicated text of a
letter from Janssen-Ortho Inc.
Contact the company for a copy of any references, attachments or
enclosures.
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PUBLIC ADVISORY
IMPORTANT SAFETY INFORMATION REGARDING TOPAMAX*: DECREASED SWEATING
AND ELEVATED BODY TEMPERATURE
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Updated Safety Information for Patients Taking TOPAMAX* (topiramate)
Regarding Decreased Sweating and Elevated Body Temperature
Announced in Canada
Toronto, July 17, 2003 - Janssen-Ortho Inc., following discussions
with Health Canada, is alerting patients, parents and healthcare professionals
of emerging safety information in patients taking TOPAMAX.
There have been rare reports of decreased sweating and increased body
temperature in patients taking TOPAMAX. Decreased sweating and increased
body temperature may have potentially serious health consequences (two
reports of hospitalizations) and may be preventable by prompt recognition
of symptoms and appropriate treatment. Reports have primarily involved
children and most cases have occurred in association with exposure to
warm weather and/or energetic activity.
Patients or parents should ensure that they/their children drink lots
of water prior to and during activities such as exercise and exposure
to warm temperatures. Parents should monitor their children closely for
evidence of decreased sweating and increased body temperature, particularly
in hot weather, and they should contact their doctor or health professional
if these symptoms are observed. Do not discontinue TOPAMAX without first
consulting your doctor.
Information about this safety update has been sent to doctors and pharmacists
to ensure that they are aware of this new safety information. The company
is working with Health Canada to update the Canadian prescribing information
for TOPAMAX. In the interim, all healthcare professionals are advised
to review the product monograph for TOPAMAX and the letter that the company
recently sent to healthcare professionals.
TOPAMAX has been approved for use in Canada since 1997 for the treatment
of epilepsy. As of February 2002, information based on experience with
more than 1.2 million patients worldwide shows that health care professionals
have reported decreased sweating and increased body temperature in 43
patients treated with TOPAMAX, including one patient in Canada.
A copy of this public advisory is available at 
http://www.janssen-ortho.com.
Janssen-Ortho Inc. is a research-based pharmaceutical company located
in Toronto.
For further information:
Alexandra Gillespie
(416) 449-9444
* All trademark rights used under license
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Any suspected adverse reactions can also be
reported to:
Canadian Adverse Drug Reaction Monitoring
Program (CADRMP)
Marketed Health Products Directorate
HEALTH CANADA
Address Locator: 0201C2
OTTAWA, Ontario, K1A 1B9
Tel: (613) 957-0337 or Fax: (613) 957-0335
Toll free for consumers and health professionals:
Tel: 866 234-2345, Fax: 866 678-6789
cadrmp@hc-sc.gc.ca
The AR Reporting Form
and the AR Guidelines can be
found on the TPD web site or in The Canadian Compendium of Pharmaceuticals
and Specialties.
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