fda strengthens NSAID warning

FDA strengthens heart attack, stroke warning for popular painkillers

Before you reach into the medicine cabinet in search of relief for a headache, fever or back pain, you should be mindful of the U.S. Food and Drug Administration (FDA)’s recent update to safety warnings on widely used painkillers.

The FDA recently strengthened an existing warning that non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs), like ibuprofen and naproxen, can increase the risk of heart attack or stroke.

The update affects both over-the-counter (OTC) and prescription drug labels. Certain OTC painkillers contain existing warnings that they “could cause” an increased risk of heart attack and stroke. The FDA now mandates a more explicit warning, saying NSAIDs “cause an increased risk” of heart attack and stroke.

The strengthened language aims to educate individuals about the cardiovascular risk associated with these common medications. Studies have demonstrated that people taking high dosages of NSAIDs over a long-term period have an increased risk of heart attacks.

Despite the updated warnings, NSAIDs can still be taken to effectively treat pain, inflammation and fever.

However, “be careful not to take more than one product that contains an NSAID at a time,” recommends Karen M. Mahoney, M.D., deputy director of FDA’s Division of Nonprescription Drug Products. “As always, consumers must carefully read the Drug Facts label for all nonprescription drugs. Consumers should carefully consider whether the drug is right for them, and use the medicine only as directed. Take the lowest effective dose for the shortest amount of time possible.”


While taking medication that contains an NSAID, the FDA warns to contact a doctor if you experience symptoms of “chest pain, trouble breathing, sudden weakness in one part or side of the body, or sudden slurred speech.”

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FDA strengthens heart attack, stroke warning for popular painkillers