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. |
PUBLIC ADVISORY
Health Canada Endorsed Important
Safety Information on Celebrex (celecoxib) |
| Subject: |
Updated safety information on CELEBREX* (celecoxib) |
KIRKLAND, September 2005 - Pfizer Canada Inc., following discussions with Health Canada, is informing you of new safety information regarding CELEBREX* (celecoxib), a medication used for the relief of symptoms associated with osteoarthritis and adult rheumatoid arthritis. CELEBREX is also used for the short-term (one week or less) management of pain. The Product Monograph has been updated to reflect the following new safety information. Pfizer Canada has also issued a letter to health professionals advising them of this new safety information.
Health Canada acknowledges that as a group, selective COX-2 inhibitor NSAIDs are associated with an increased risk of cardiovascular events, a risk that is similar to those associated with most NSAIDs and consequently, will issue guidance to manufacturers, establishing standards for the risk and benefit information that must be included in product labelling of NSAIDs.
New safety information concerning the use of CELEBREX* are as follows:
- CELEBREX should not be used before or after heart surgery. Patients who took a drug in the same class as CELEBREX after a type of heart surgery (coronary artery bypass grafting (CABG)) were more likely to have heart attacks, strokes, blood clots in the leg(s) or lung(s), and infections and/or other complications than those who did not take that drug.
- Caution should be exercised in patients taking CELEBREX with the following medical conditions: Heart attack, angina, stroke, mini-strokes, congestive heart failure (moderate to severe) and loss of vision.
- CELEBREX should not be used during the later stage of pregnancy (after 28 weeks), or by patients who are breastfeeding or plan to breastfeed.
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- Caution should also be exercised when CELEBREX is used in patients with high blood pressure, high cholesterol, diabetes mellitus, congestive heart failure (mild), atherosclerosis, poor circulation to their extremities, are a smoker, ex-smoker, or have kidney failure.
- CELEBREX should be prescribed and used at the lowest effective dose, and for the shortest possible duration.
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 further reference, please see Health Canada's news release:
http://www.hc-sc.gc.ca/ahc-asc/media/nr-cp/2005/2005_75_e.html
The full copy of the Product Monograph can be found at:
 http://www.pfizer.ca
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 CELEBREX 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
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:
Bureau of Metabolism, Oncology and Reproductive Sciences (BMORS)
BMORS_enquiries@hc-sc.gc.ca
Tel: (613) 941-3171
Fax: (613) 941-1365
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, MD, MBA
Vice President and Medical Director
Pfizer Canada Inc.
* CELEBREX is a registered trademark of G.D. Searle & Co., Pfizer Canada Inc, Licensee
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