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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.
Advise patients to be alert for the symptoms of congestive heart failure including shortness of breathunexplained weight gainor edema and to contact their healthcare provider if such symptoms occursee WARNINGS AND PRECAUTIONS
Based on the mechanism of actionthe use of prostaglandin-mediated NSAIDsincluding FELDENEmay delay or prevent rupture of ovarian follicleswhich has been associated with reversible infertility in some womenPublished animal studies have shown that administration of prostaglandin synthesis inhibitors has the potential to disrupt prostaglandin-mediated follicular rupture required for ovulationSmall studies in women treated with NSAIDs have also shown a reversible delay in ovulationConsider withdrawal of NSAIDsincluding FELDENEin women who have difficulties conceiving or who are undergoing investigation of infertility.
Concomitant use with other NSAIDsincluding COX-2 selective NSAIDs and acetylsalicylic acid at analgesic doses.
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