FDA WARNS OF HEART ATTACK AND STROKE RISK OF NSAIDs
FDA Drug Safety Communication: FDA strengthens warning that non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs) can cause heart attacks or strokes. www.fda.gov/Drugs/DrugSafety/ucm451800.htm. Accessed November 19, 2015.
The FDA has added heart attack and stroke warnings to OTC nonaspirin NSAIDs. The warning is similar to that added to prescription NSAIDs in 2005.
People who have cardiovascular disease, particularly those who recently had a heart attack or cardiac bypass surgery, are at the greatest risk for cardiovascular adverse events associated with NSAIDs, according to the FDA announcement.
While people who have already had a heart attack are most vulnerable for having another or for dying of heart attack–related causes if treated with NSAIDs, everyone may be at risk—even those without an underlying risk for CVD.
COMMENTARY
This new statement was based on a comprehensive review of observational studies and clinical trials published since the FDA boxed warning appeared in 2005. The primary changes reflect that the risk for heart attack or stroke can occur as early as the first few weeks of using an NSAID, and the risk increases with longer use and higher doses. The estimates of the level of increased risk range from 10% to more than 50%, depending on the medication and the doses studied. The relative increase in risk is similar for patients with and without heart disease, but of course the likelihood of an adverse event is higher in patients with existent heart disease because of the increased prevalence of cardiovascular outcomes. NSAIDs also increase the risk for congestive heart failure.
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