Acunivive 30 Injection System and Thrombosis

The use of nonsteroidal anti-inflammatory drugs (NSAIDs) may be associated with an increased risk of cardiovascular thrombotic events such as myocardial infarction and stroke, which can be fatal. The risk may increase with duration of use. Clinical trials of several cyclooxygenase-2 (COX-2) selective and nonselective NSAIDs of up to three years duration have supported this association. Although not all NSAIDs have been studied, investigators believe it may be a class effect, and that the risk may be similar for all NSAIDs, both COX-2 selective and nonselective. Therapy with NSAIDs should be administered cautiously in patients with a history of cardiovascular or cerebrovascular disease. Patients should be treated with the lowest effective dosage for the shortest duration necessary. Appropriate antiplatelet therapy should be administered to patients requiring cardioprotection. However, there is no consistent evidence that concurrent use of aspirin mitigates the increased risk of serious cardiovascular thrombotic events associated with NSAID use, while the risk of serious GI events is increased. Patients should be advised to promptly seek medical attention if they experience symptoms that could indicate a cardiovascular thrombotic event such as chest pain, shortness of breath, weakness, and slurring of speech.

NSAIDs are contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery. Two large clinical trials of a COX-2 inhibitor for the treatment of pain in the first 10 to 14 days following CABG surgery found an increased incidence of myocardial infarction and stroke.