Health Canada
www.hc-sc.gc.ca
Common menu bar links
Bextra (valdecoxib) - Cardiovascular Risks and Serious Skin Reactions
Help on accessing alternative formats, such as Portable Document Format (PDF), Microsoft Word and PowerPoint (PPT) files, can be obtained in the alternate format help section.
(PDF Version - 59 K)Contact BMORS Enquiries
The Health Products and Food Branch (HPFB) posts on the Health Canada web site safety alerts, public health advisories, press releases and other notices as a service to health professionals, consumers, and other interested parties. These advisories may be prepared with Directorates in the HPFB which includes pre-market and post-market areas as well as market authorization holders and other stakeholders. Although the HPFB grants market authorizations or licenses for therapeutic products, we 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 Pfizer Canada Inc.
Contact the company for a copy of any references, attachments or enclosures.
December 10, 2004
Subject: BEXTRA* (valdecoxib) tablets - Cardiovascular Risks and Serious Skin Reactions
Dear Health Care Professional,
Pfizer Canada Inc., following discussions with Health Canada1, would like to inform you of new safety information for BEXTRA* (valdecoxib) tablets. The Product Monograph for BEXTRA is being revised to reflect the following:
CONTRAINDICATIONS:
- BEXTRA has NOT been approved for use in any peri- and/or post-operative setting and should not be used for any unauthorized indication.
- BEXTRA is CONTRAINDICATED for the treatment of pain post-coronary artery bypass surgery (CABG), as the use of BEXTRA in such patients in this setting has led to an increased incidence of cardiovascular/thromboembolic events, deep surgical infections or sternal wound complications.
WARNINGS and PRECAUTIONS
- Caution should be exercised in prescribing Bextra to patients with ischaemic heart disease or other significant risk factors predisposing to cardiovascular events such as CHF, unstable angina, uncontrolled hypertension, myocardial infarction, transient ischemic attack and stroke.
- A boxed warning regarding Serious Skin Reactions is being added.
- A previous warning regarding the occurrence of serious skin reactions is being expanded.
CONTRAINDICATIONS: Cardiovascular Risks
A study was conducted with BEXTRA used postoperatively in patients who had undergone coronary artery bypass surgery (CABG). The safety analysis of the data indicates an increased incidence of cardiovascular/thromboembolic events, deep surgical infections or sternal wound complications in patients who received BEXTRA post-coronary artery bypass surgery (CABG).
Therefore, use of BEXTRA (valdecoxib) is CONTRAINDICATED in patients for treatment of postoperative pain following coronary artery bypass surgery (CABG).
Caution should be exercised in prescribing Bextra to patients with ischaemic heart disease or other significant risk factors predisposing to cardiovascular events such as CHF, unstable angina, uncontrolled hypertension, myocardial infarction, transient ischemic attack and stroke.
It should be noted that randomized controlled clinical trials with BEXTRA longer than one year have not been done, nor have studies powered to detect differences in cardiovascular adverse events in a chronic setting been conducted.
Pfizer is planning further studies to assess the long-term cardiovascular safety of BEXTRA in patients who require chronic treatment for arthritis.
BEXTRA continues to be indicated for the acute and chronic treatment of the signs and symptoms of adult rheumatoid arthritis (RA) and osteoarthritis (OA), as well as to relieve pain associated with primary dysmenorrhea (PD).
The safety and efficacy of BEXTRA (valdecoxib) in other settings has NOT been evaluated by Health Canada.
SERIOUS SKIN REACTIONS
When BEXTRA was introduced for use in Canada in January 2003, the Product Monograph included information regarding the occurrence of rare cases of serious skin reactions and cases of hypersensitivity reactions in patients with or without a history of allergic-type reaction to sulfonamides.
At this time, the BEXTRA Product Monograph is being revised to include a warning regarding serious cutaneous reactions as follows:
Serious Skin Reactions
- Serious skin reactions (e.g. Toxic Epidermal Necrolysis, Stevens-Johnson Syndrome, and Erythema Multiforme) have been reported in patients using BEXTRA. Some of these cases have resulted in death.
- These serious skin reactions more commonly occur within the first 2 weeks of treatment, but may occur at any time during treatment.
- These serious skin reactions may occur in patients with or without a known history of a sulfonamide allergy.
- The reported rate of these serious skin events appears to be greater for BEXTRA as compared to other selective Cyco-oxygenase-2 (COX-2) inhibitor Non-Steroidal Anti-Inflammatory Drugs (NSAIDS).
- BEXTRA should be discontinued at the first signs of skin rash, mucosal lesions or any other signs of hypersensitivity, and urgent medical attention should be sought.
The identification, characterization, and management of drug-related adverse events are dependent on the active participation of health care professionals in adverse drug reaction reporting programmes. Healthcare professionals are asked to report any suspected adverse reactions in patients receiving BEXTRA* to the following addresses:
Pfizer Canada Inc.
Drug Safety
P.O. Box 800
Pointe-Claire- Dorval, Quebec
H9R 4V2
1 800 463-6001
Any suspected adverse reaction can also be reported to:
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: 866 234-2345
Fax: 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.
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 use of drugs.
If you require any further information on BEXTRA please contact Pfizer Medical Information at 1-800-463-6001.
Sincerely,
original signed by
Bernard Prigent, M.D.
Vice-President and Medical Director
Pfizer Canada Inc.
* BEXTRA is a registered trademark of Pharmacia Enterprises S.A., Pfizer Canada Inc, Licensee
1 Health Canada is continuing to evaluate the safety of all selective Cyclo-oxygenase-2 (COX-2) inhibitor Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) in light of recent concerns regarding cardiovascular risks associated with the use of another selective COX-2 inhibitor NSAID.
