The Food and Drug Administration (FDA) has enforced a class wide safety warning that is to be included in the labeling for all non-steroidal anti-inflammatory drugs (NSAIDs) regarding risks of cardiovascular thrombotic events, heart failure, and edema.
The updated Warnings and Precautions section now includes data regarding an increased risk of serious cardiovascular thrombotic events, including myocardial infarction (MI) and stroke, which can be fatal. In clinical trials, patients with known cardiovascular disease or risk factors had a higher absolute incidence of excess serious cardiovascular thrombotic events, due to their increased baseline rate. The increased risk was reported to begin as early as the first weeks of treatment in some observational studies.
The lowest effective dose for the shortest duration possible should be used to minimize the potential risk for an adverse cardiovascular event. Patients and physicians should monitor for the development of these effects even in the absence of previous symptoms. The update states that the concurrent use of aspirin and an NSAID increases the risk of serious gastrointestinal (GI) events.
Also, NSAIDs are contraindicated in the setting of coronary artery bypass graft (CABG) surgery following data from two large, controlled clinical trials. The studies demonstrated an increased incidence of myocardial infarction and stroke.
Additional data demonstrating an increased risk of reinfarction, cardiovascular-related death, and all-cause mortality starting in the 1st week of treatment have been included in the labeling. As a result, NSAID use should be avoided in patients with a recent myocardial infarction (MI) unless the benefits are expected to outweigh the risk of recurrent cardiovascular thrombotic events. If the NSAID is administered, patients should be monitored for cardiac ischemia.
The updated safety information states that the use of NSAIDs may blunt the cardiovascular effects of certain drugs used to treat heart failure and edema, such as diuretics, ACE inhibitors or ARBS. NSAIDs should be avoided in patients with severe heart failure unless the benefits are expected to outweigh the risk of worsening heart failure. If the NSAID is administered, patients should be monitored for worsening heart failure.
For more information visit FDA.gov.