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Nonsteroidal anti-inflammatory drugsincluding piroxicammay rarely increase the risk for a heart attack or strokeThis effect can happen at any time while taking this drug but is more likely if you take it for a long timeThe risk may be greater if you have heart disease or increased risk for heart diseasefor exampledue to smokingfamily history of heart diseaseor conditions such as high blood pressure or diabetesDo not take this drug right before or after heart bypass surgeryCABG

Patients and physicians should remain alerted for signs and symptoms of GI ulceration and/or bleeding during piroxicam treatmentPatients should be asked to report any new or unusual abdominal symptom during treatmentIf a gastrointestinal complication is suspected during treatmentpiroxicam should be discontinued immediately and additional clinical evaluation and treatment should be considered.

A subpopulation of patients with asthma may have aspirin-sensitive asthma which may include chronic rhinosinusitis complicated by nasal polypsseverepotentially fatal bronchospasmand/or intolerance to aspirin and other NSAIDsBecause cross-reactivity between aspirin and other NSAIDs has been reported in such aspirin-sensitive patientsFELDENE is contraindicated in patients with this form of aspirin sensitivitysee CONTRAINDICATIONSWhen FELDENE is used in patients with preexisting asthmawithout known aspirin sensitivitymonitor patients for changes in the signs and symptoms of asthma.

Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptomssee section 4.4

Given that piroxicam has been shown to be associated with an increased risk of gastrointestinal complicationsthe need for possible combination therapy with gastro-protective agentse.gmisoprostol or proton pump inhibitorsshould be carefully consideredin particular for elderly patients.

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