FDA Requiring Stronger Heart Attack & Stroke Warnings For Many Common Painkillers

The warning labels for Advil and other ibuprofen-containing drugs will soon be updated to more accurately reflect concerns about heart attack and stroke risks. (photo: frankieleon)

The Food and Drug Administration is looking to make consumers more aware of potential risks for heart attack and stroke associated with a popular class of painkillers that many of us use on a frequent basis for everyday aches and soreness.

Nonsteroidal anti-inflammatory drugs (NSAIDs) are a class of prescription and over-the-counter medications that include ibuprofen (like you’d find in Motrin or Advil), and naproxen (most popularly used in Aleve). Aspirin is also an NSAID but the FDA is not including it in these label changes.

The labels for these drugs already contain information about the risk of heart attack and stroke, but the FDA is directing manufacturers to update their labels with more specific information in the coming months, including:

• The risk of heart attack or stroke can occur as early as the first weeks of using an NSAID. The risk may increase with longer use of the NSAID.

• The risk appears greater at higher doses.

• NSAIDs can increase the risk of heart attack or stroke in patients with or without heart disease or risk factors for heart disease.

• In general, patients with heart disease or risk factors for it 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.

• Patients treated with NSAIDs following a first heart attack were more likely to die in the first year after the heart attack compared to patients who were not treated with NSAIDs after their first heart attack.

• There is an increased risk of heart failure with NSAID use.

“Be careful not to take more than one product that contains an NSAID at a time,” says 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.”

by Chris Morran via Consumerist