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Elderly patientscompared to younger patientsare at greater risk for NSAID-associated serious cardiovasculargastrointestinaland/or renal adverse reactionsIf the anticipated benefit for the elderly patient outweighs these potential risksstart dosing at the low end of the dosing rangeand monitor patients for adverse effectssee WARNINGS AND PRECAUTIONS

The correlation between findings of short-term endoscopic studies with CELEBREX and the relative incidence of clinically significant serious upper GI events with long-term use has not been establishedSerious clinically significant upper GI bleeding has been observed in patients receiving CELEBREX in controlled and open-labeled trialssee WARNINGS AND PRECAUTIONS and Clinical Studies

Some adverse reactions occurred in higher percentages of patients than in the arthritis pre-marketing trialstreatment durations up to 12 weekssee Adverse events from CELEBREX pre-marketing controlled arthritis trialsaboveThe adverse reactions for which these differences in patients treated with CELEBREX were greater as compared to the arthritis pre-marketing trials were as follows:

Avoid the use of CELEBREX in patients with severe heart failure unless the benefits are expected to outweigh the risk of worsening heart failureIf CELEBREX is used in patients with severe heart failuremonitor patients for signs of worsening heart failure.

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.

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