Archived - Important Safety Information Regarding TOPAMAX: Decreased Sweating and Elevated Body Temperature - For the Public

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

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.