Nonsteroidal Anti-Inflammatory Drugs and Risk of Heart Attack or Stroke - FDA Strengthens Warning
July 23, 2015
FDA is requiring updates to current warnings regarding the increased risk of serious cardiovascular events associated with nonsteroidal anti-inflammatory drugs (NSAIDs) other than aspirin. These changes are based on results of a meta-analysis, observational studies, and input form FDA advisory committees showing the relative risk of serious cardiovascular events was increased by 10% to 50% with NSAID use. Cardiovascular risk increased with higher NSAID doses and longer duration of use, although some observational studies concluded that significant risk can occur in the first weeks of NSAID use. Data are insufficient to definitively determine if certain NSAIDs pose a greater or lower cardiovascular risk. Patients with cardiovascular disease or risk factors may have a greater risk of developing a cardiovascular event during NSAID therapy because they have a higher baseline risk. Cardiovascular risk is also increased in healthy patients using NSAIDs. Use of NSAIDs after a first heart increases the risk of death in the first year after the event. The risk of heart failure requiring hospitalization is also increased with NSAID use.
Monitor patients for symptoms of heart attack or stroke (eg, chest pain, shortness of breath, dyspnea, unilateral weakness, dysarthria) throughout the whole duration of NSAID treatment regardless of previous cardiovascular disease or risk factors. Use NSAIDs at the lowest possible dose for the shortest duration to minimize cardiovascular risk. Encourage patients to read the updated medication guide.
- MedWatch Safety Alert - July 09, 2015
- Drug Safety Communication - July 09, 2015
July 23, 2015; University of Utah, Drug Information Service. Copyright 2015, Drug Information Service, University of Utah, Salt Lake City, UT.