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FDA Warns of Heart and Stroke Dangers of Common Pain Relievers

Jul 17, 2015

The Food and Drug Administration (FDA) has warned that common painkillers like Motrin, Aleve, and Advil can increase the risk of a heart attack or stroke.

These popular painkillers-nonsteroidal anti-inflammatory drugs-are available in both prescription and over-the-counter formulas and are widely used to treat pain and fever from short- and long-term medical conditions such as arthritis, menstrual cramps, headaches, colds, and the flu.

They are often taken in larger doses than recommended and as a form of long-term medication. Dr. Denes Korpas, a cardiologist at the Nebraska Heart Institute and Heart Hospital, said, "A lot of my patients ask 'Which one is more harmless, which one is better for me . . . some studies . . . maybe suggest Aleve is better, but the recent studies do not make a difference between those and really they are on the same level. There's no such thing that this one maybe is better." Dr. Korpas said Tylenol is a good alternative to these common painkillers, Nebraska television station 1011 Now reports. Because both prescription and OTC medicines contain NSAIDs, the FDA says consumers should be careful to avoid taking multiple medications with the same active ingredient.

The FDA says patients taking any NSAID should be aware of symptoms that could signal a heart attack or stroke. Symptoms include chest pain, shortness of breath, trouble breathing, weakness in one part or side of their body, or slurred speech. Anyone experiencing such symptoms should seek immediate medical attention.

The DA has ordered stronger label warnings that non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs) increase the chance of a heart attack or stroke. The agency is requiring updates to the drug labels of all prescription NSAIDs. NSAIDs affected by the new warnings include brand name and generic drugs such as ibuprofen (Advil, Motrin), naproxen (Aleve), indomethacin (Indocin, Tivorbex), and prescription arthritis drugs such as Celebrex (celecoxib). The Drug Facts labels for over-the-counter (OTC) non-aspirin NSAIDs already contain information on heart attack and stroke risk, but the FDA will request updates to strengthen the OTC non-aspirin NSAID Drug Facts labels.

The FDA statement says the risk of heart attack or stroke can occur as early as the first weeks of using an NSAID and the risk may increase with longer use. The risk appears greater at higher doses. The risk may not be the same for all NSAIDs, but the FDA said at this time it does not have enough information to determine whether the risk of a particular NSAID is higher or lower.

NSAIDs can increase the risk of heart attack or stroke in patients with or without heart disease or risk factors for heart disease, but in general, patients with heart disease or its risk factors have a greater likelihood of heart attack or stroke following NSAID use than patients without these risk factors because they have a higher risk at baseline. Because many prescription and OTC medicines contain NSAIDs, consumers should avoid taking multiple medications with the same active ingredient, the FDA said.

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