All NSAID Labels Must Be Revised to Reflect Heart Risks

The FDA is requiring all non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs) to include strengthened label warnings describing how the painkillers increase the odds of heart attack or stroke.

Since these increased risks were first described in the Boxed Warning and Warnings and Precautions sections of the prescription drug labels in 2005, the FDA has reviewed new safety information on both prescription and OTC NSAIDs from observational studies, clinical trials, and scientific publications.

Based on the FDA’s review and its advisory committees’ recommendations, the labels of prescription NSAIDs such as ibuprofen, naproxen, diclofenac, and celecoxib must be revised to describe the following warnings:

• The risk of heart attack or stroke can occur within the first few weeks of NSAID use, and it may increase with longer use.
• Risk appears to increase as the dose increases.
• It is less clear whether all NSAIDs pose the same risk of heart attack or stroke, but the data are insufficient to determine whether the risk of any particular NSAID is higher or lower than that of another.
• Patients without heart disease or risk factors for it are still at risk for heart attack or stroke when using NSAIDs.
• NSAID use increases the risk of heart failure.

The FDA said it will request similar updates to the existing labels of OTC non-aspirin NSAIDs.

In the meantime, patients using NSAIDs should seek immediate medical attention if they experience symptoms of heart attack or stroke, such as chest pain, shortness of breath, weakness in one side of their body, or slurred speech.

Health care professionals and patients are encouraged to remain alert for these side effects and report them to the FDA’s MedWatch program.