Nexcede

Black Box Warnings

Cardiovascular Risk

• NSAIDs may increase risk of serious cardiovascular thrombotic events, myocardial infarction (MI), & stroke, which can be fatal
• Risk may increase with duration of use
• Patients with risk factors for or existing cardiovascular disease may be at greater risk
• NSAIDs are contraindicated for perioperative pain in the setting of coronary artery bypass graft (CABG) surgery (increased risk of MI & stroke)

Gastrointestinal Risk

• NSAIDs increase risk of serious GI adverse events including bleeding, ulceration, & perforation of the stomach or intestines, which can be fatal
• GI adverse events may occur at any time during use & without warning symptoms
• Elderly patients are at greater risk for serious GI events

Contraindications

Absolute: ASA allergy

Relative: Bleeding disorders, hepatic disease, peptic ulcer, stomatitis, ulcerative colitis, upper GI disease, late pregnancy (may cause premature closure of the ductus arteriosus)

Cautions

Use caution in asthma (bronchial), cardiac disease, CHF, HTN, renal impairment, SLE

Long-term administration of NSAIDs may result in renal papillary necrosis and other renal injury; patients at greatest risk include the elderly, or those with impaired renal function, hypovolemia, heart failure, liver dysfunction, salt depletion, and individuals taking diuretics, ACE inhibitors, or ARBs

Heart Failure (HF) risks

• NSAIDS have the potential to trigger HF by prostaglandin inhibition that leads to sodium and water retention, increased systemic vascular resistance, and blunted response to diuretics
• NSAIDS should be avoided or withdrawn whenever possible
• AHA/ACC Heart Failure Guidelines; Circulation. 2016; 134