Pfizer Canada Inc., following discussions with Health Canada, has released new safety information regarding Celebrex (celecoxib), a medication used for the relief of symptoms associated with osteoarthritis and adult rheumatoid arthritis as well as a short-term (one week or less) management of pain. The Product Monograph has been updated to reflect the following 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 labeling 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.
- 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.