Health Canada
www.hc-sc.gc.ca
Common menu bar links
Pfizer Canada Inc. Issues Warnings about Bextra - Cardiovascular Risks and Serious Skin Reactions - Pfizer Canada Inc. - For The Public
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 - 83 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.
Health Canada Endorsed Important Safety Information on
BEXTRA (valdecoxib) tablets
Subject: Pfizer Canada Inc. Issues Warnings about BEXTRA*- Cardiovascular Risks and Serious Skin Reactions
KIRKLAND, December 2004 - Pfizer Canada Inc., following discussions with Health Canada1, is informing you of new safety warnings regarding BEXTRA* (valdecoxib) a medication used to treat the signs and symptoms of osteoarthritis, adult rheumatoid arthritis, and pain due to menstrual cramping. Pfizer Canada recently sent a letter to healthcare professionals advising them of the following safety information.
CARDIOVASCULAR RISKS
BEXTRA should not be used before or after any surgery or other situations where its use has not been approved. In a recently completed clinical trial, more patients who were treated with BEXTRA for pain following coronary artery bypass graft surgery (CABG) experienced cardiovascular events such as heart attacks or strokes, blood clots in the leg(s) or lung(s), and infections and/or other complications in the surgical site.
- BEXTRA is NOT approved for use after surgery in any setting. Specifically, BEXTRA
(valdecoxib) should NOT be used after coronary artery bypass graft
surgery (CABG).
- Patients already taking BEXTRA should discuss with their doctors whether BEXTRA should be temporarily
discontinued before, during and after any surgery.
- Before using BEXTRA or if you already are taking BEXTRA, talk to your doctor if you have ischemic heart disease or believe you have any significant risk factors predisposing you to cardiovascular events such as congestive heart failure (CHF), unstable angina, uncontrolled hypertension (high blood pressure), myocardial infarction (heart attack), transient ischemic attack and stroke.
It should be noted that, to date, there have been no studies where patients used BEXTRA for more than one year, or that can show whether or not long-term use of BEXTRA is associated with an increased risk of cardiovascular adverse events.
Pfizer is planning further studies to assess the long-term cardiovascular safety of BEXTRA in patients who require chronic treatment for arthritis.
SERIOUS SKIN REACTIONS
Serious skin reactions (such as Toxic Epidermal Necrolysis, Stevens-Johnson Syndrome, and Erythema Multiforme) have been reported in patients taking BEXTRA since the introduction of the product on the Canadian market in January 2003. Healthcare providers' prescribing information and patients' instructions for BEXTRA are being modified to reflect the higher reported rate of these events with BEXTRA than with other selective COX-2 inhibitor NSAIDs:
- 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 Cyclo-oxygenase-2 (COX-2) inhibitor Non-Steroidal Anti-Inflammatory Drugs (NSAIDs).
Given the potentially serious nature of these skin reactions, patients are advised of the following:
- Talk to your doctor or pharmacist, before you use BEXTRA if you or a family member are allergic to or have had a reaction to BEXTRA, sulfonamide drugs or other anti-inflammatory drugs manifesting itself by increased sinusitis, hives, the initiating or worsening of asthma or anaphylaxis (sudden collapse);
- STOP TAKING BEXTRA at the first appearance of skin rash, mucosal lesions (such as sores in the mouth), and/or any other sign of an allergic reaction or if you experience any trouble breathing, wheezing, and/or chest tightness and SEEK EMERGENCY MEDICAL ATTENTION.
For more information about the revisions to the prescribing information, patients should consult their healthcare professional. Patients should NOT discontinue their medication without consulting their physician first.
For media inquiries, please contact Mr. Michael Amos, Pfizer Canada Inc, (514) 693-4587.
The safety of patients is a priority for Pfizer Canada Inc. Information about adverse drug reactions is gathered by both Pfizer Canada Inc. and Health Canada, via its Canadian Adverse Drug Reaction Monitoring Program (CADRMP). Any suspected adverse drug reactions in patients receiving BEXTRA can be reported to:
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
Alternatively, 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.
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.
