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Clinical trials of several COX-2 selective and nonselective NSAIDs of up to three years duration have shown an increased risk of serious cardiovascularCVthrombotic eventsincluding myocardial infarctionMIand strokewhich can be fatalBased on available datait is unclear that the risk for CV thrombotic events is similar for all NSAIDsThe relative increase in serious CV thrombotic events over baseline conferred by NSAID use appears to be similar in those with and without known CV disease or risk factors for CV diseaseHoweverpatients with known CV disease or risk factors had a higher absolute incidence of excess serious CV thrombotic eventsdue to their increased baseline rateSome observational studies found that this increased risk of serious CV thrombotic events began as early as the first weeks of treatmentThe increase in CV thrombotic risk has been observed most consistently at higher doses.

This is not a complete list of side effects and others may occurTell your doctor about any unusual or bothersome side effectYou may report side effects to FDA at 1-800-FDA-1088.

SeeWhat is the most important information I should know about medicines called Nonsteroidal Anti-inflammatory DrugsNSAIDs

After observing the response to initial therapy with FELDENEthe dose and frequency should be adjusted to suit an individual patient’s needs.

Increased risk of a heart attack or stroke that can lead to deathThis risk may happen early in treatment and may increasewith increasing doses of NSAIDs with longer use of NSAIDs.

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