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Patients with a prior history of peptic ulcer disease and/or GI bleeding who used NSAIDs had a greater than 10fold increased risk for developing a GI bleed compared to patients without these risk factorsOther factors that increase the risk of GI bleeding in patients treated with NSAIDs include longer duration of NSAID therapyconcomitant use of oral corticosteroidsaspirinanticoagulantsor selective serotonin reuptake inhibitorsSSRIssmokinguse of alcohololder ageand poor general health statusMost postmarketing reports of fatal GI events occurred in elderly or debilitated patientsAdditionallypatients with advanced liver disease and/or coagulopathy are at increased risk for GI bleeding.
History of previous serious allergic drug reaction of any typeespecially cutaneous reactions such as erythema multiformeStevens-Johnson syndrometoxic epidermal necrolysis.
In patients who are known or suspected to be poor CYP2C9 metabolizers based on genotype or previous history/experience with other CYP2C9 substratessuch as warfarin and phenytoinconsider dose reduction as they may have abnormally high plasma levels due to reduced metabolic clearance.
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