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Celebrex labels changed to reflect increased cardiovascular risks

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TORONTO (CP) - Doctors were instructed Wednesday they should not prescribe the popular painkiller Celebrex to certain patients because of the potential increased risk of adverse events like heart attack and stroke that are associated with its use.

Patients about to undergo or recovering from heart surgery should not be given the drug, nor should women in late stages of pregnancy (after 28 weeks), breastfeeding or considering breastfeeding, Health Canada said as it announced changes to the labelling - called the product monograph - for the drug.

The department also said Celebrex should be used with caution in patients who have suffered heart attack, angina, stroke, mini-strokes, congestive heart failure (moderate to severe) and loss of vision.

Caution should also be used in patients with high blood pressure, high cholesterol, diabetes, heart failure, poor circulation, kidney failure or in people who smoke or previously smoked.

The changes stem from a review of the class of drugs to which Celebrex belongs, called cox 2 inhibitors. The review was triggered after Celebrex's main rival, Vioxx, was pulled from the market a year ago when studies suggested people taking it were at increased risk of heart attack and stroke.

Subsequent studies suggested all the cox 2s may elevate the risk of adverse cardiovascular events. And drug regulators in both Canada and the United States held public hearings to consider whether they should stay on the market.

In July, the expert panel that reviewed the drugs for Health Canada ruled Celebrex, made by Pfizer, should be allowed to stay on the market and Merck should be allowed to reintroduce Vioxx in Canada.

A third cox 2 drug, Bextra, which is associated with a rare but dangerous skin condition, was ordered off the market. Bextra is a Pfizer drug.

Health Canada is working with the drug makers to revise the product monographs of all non-steroidal anti-inflammatory drugs - both cox 2s and others - to include information about potential cardiovascular risks.

The new labelling stresses that patients should take the lowest dose for the shortest time possible, and includes a new restriction stipulating acute pain use should be limited to seven consecutive days.

© The Canadian Press, 2005

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