Nonsteroidal anti-inflammatory drugs (NSAIDs) currently carry a warning about the risks of heart attack and stroke. The U.S. Food and Drug Administration (FDA) is strengthening this warning based on a review of new safety information, the agency said in a safety alert. All prescription NSAIDs are required to update their labels. The FDA also requests that over-the-counter (OTC) NSAIDs revise their labels to reflect an increased risk of stroke and heart attack. OTC NSAIDs are used for fever or temporary pain relief while prescription NSAIDs are used for several kinds of arthritis and other painful conditions. The new warning does not apply to aspirin, which is also an NSAID.
The FDA last updated the NSAID label to warn about “the risk of heart attack and stroke with NSAIDs, either of which can lead to death” in 2005. The boxed warning is the most serious type of warning available.
Users are advised to watch for heart-related side effects when taking NSAIDs and should seek medical attention immediately if they experience chest pain, shortness of breath, trouble breathing, weakness in one part or side fo their body or slurred speech. Side effects and injuries should be reported to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.