Update to NSAID Warning Labels to Include Heart Attack and Stroke Risk Information

In a Safety Alert dated July 9, the U.S. Food and Drug Administration (FDA) said on its website that the agency is strengthening an existing label warning that non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs) increase the risk of a heart attack or stroke.

Although prescription and over-the-counter (OTC) NSAID drugs already contain information on heart attack and stroke risk, the agency said it decided to issue the update after undertaking a comprehensive review of new safety information about both types of NSAIDs. The information came from observational studies, a large combined analysis of clinical trials and other scientific publications. The FDA first warned of the risk of heart attack or stroke in 2005 in the Boxed Warning and Warnings and Precautions sections of the prescription drug labels. 

The agency will request updates to the OTC non-aspirin NSAID Drug Fact labels. The updated prescription NSAID safety warning labels will include the following information:

-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.

-It was previously thought that all NSAIDs may have a similar risk. Newer information makes it less clear that the risk for heart attack or stroke is similar for all NSAIDs; however, this newer information is not sufficient for us to determine that the risk of any particular NSAID is definitely higher or lower than that of any other particular NSAID.

-NSAIDs can increase the risk of heart attack or stroke in patients with or without heart disease or risk factors for heart disease. A large number of studies support this finding, with varying estimates of how much the risk is increased, depending on the drugs and the doses studied.

-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.

Patients and health care workers should remain alert for heart-related side effects while using NSAIDs. Patients taking these drugs should seek immediate medical attention if they experience chest pain, shortness of breath or trouble breathing, weakness in one part or side of their body, or slurred speech, the FDA said in the Safety Alert.

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