Archived – Important Safety Information regarding Bextra (valdecoxib) – Pharmacia and Pfizer

Important Safety Information regarding Bextra (valdecoxib)- Pharmacia and Pfizer

December 2002

Dear Healthcare Professional,

This letter is being sent out following discussions with Health Canada regarding Bextra™ (valdecoxib) which was recently approved for marketing in Canada. In addition, we bring to your attention recent safety information which has become available through postmarketing experience in other countries.

Bextra™ is indicated for acute and chronic treatment of the signs and symptoms of adult rheumatoid arthritis (RA) and osteoarthritis (OA), as well as relief of pain associated with primary dysmenorrhea (PD).

Postmarketing Safety Information:
The current Canadian Bextra™ Product Monograph contains the most recent postmarketing safety information available to date.

• This includes recent changes to the Prescribing Information for Bextra™ which have occurred in other jurisdictions regarding rare cases of serious skin reactions and cases of hypersensitivity reactions in patients with and without a history of allergic-type reactions to sulfonamides.
• Bextra™ should not be given to patients who have experienced prior allergic-type reactions to sulfonamides and should be discontinued at the first appearance of a skin rash or any other sign of hypersensitivity reaction.
• Please consult the Contraindications, Warnings and Adverse Reactions sections of the enclosed Prescribing Information.

In controlled clinical trials, Bextra™ provided relief of pain associated with primary dysmenorrhea within 30-60 minutes of administration. Relief of OA pain was achieved as early as Day 1, and relief of RA pain within 2 weeks (first clinical assessment). In OA and RA, Bextra™ has shown sustained efficacy in clinical trials of up to one year.

In controlled clinical trials, Bextra™ demonstrated a superior GI safety profile and a similar cardiovascular safety profile to comparator NSAIDs in RA and OA patients. At therapeutic doses, the cardiorenal profile of Bextra™ was also similar to comparator NSAIDs. In contrast to comparator NSAIDs, Bextra™ was shown to have no effect on platelet function.

Bextra™ is a once-a-day therapy. The recommended dose for treatment of the signs and symptoms of OA and RA is 10 mg once daily. Some patients may receive additional benefit from 20 mg once daily. A 40 mg once-daily dose (2 x 20 mg) is recommended for the relief of pain associated with primary dysmenorrhea.

Full Prescribing Information is included. The Bextra™ Product Monograph is also available on request. For Medical Information, please call 1-800-268-7888. For information on how to contact your local Pharmacia or Pfizer Sales Representative, please call Customer Service at 1-800-268-7879.

The identification, characterization, and management of drug-related adverse events are dependent on the active participation of healthcare professionals in adverse drug reaction reporting programmes. Healthcare professionals are asked to report any suspected adverse reactions in patients receiving Bextra™ to:

Pharmacia Canada Inc.
55 Standish Court, Suite 1200
Mississauga, Ontario
L5R 4E3
Attention: Medical Information and Drug Safety

Your professional commitment in this regard has an important role in protecting the well-being of your patients by contributing to early signal detection and informed drug use.

Sincerely,

original signed by

David Cook, MD
Vice President, Medical & Scientific Affairs
Pharmacia Canada Inc.

original signed by

Bernard Prigent, MD
Vice President & Medical Director
Pfizer Canada Inc.

Bextra™ is a trademark of Pharmacia & Upjohn Company, used with permission by Pharmacia Canada Inc.

Any suspected adverse drug 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 ADR Reporting Form and the ADR Guidelines can be found on the TPD web site or in The Canadian Compendium of Pharmaceuticals and Specialties.