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FDA Drug Safety Communication: FDA strengthens warning that non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs) can cause heart attacks or strokes

(7/9/2015)

The U.S. Food and Drug Administration (FDA) has strengthened the label warning that non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs) increase the chance of a heart attack or stroke. Based on a comprehensive review of safety information, updates to the drug labels of all prescription NSAIDs are required.

As is the case with current prescription NSAID labels, the Drug Facts labels of over-the-counter (OTC) non-aspirin NSAIDs already contain information on heart attack and stroke risk. Updates to the OTC non-aspirin NSAID Drug Facts labels must notify patients taking NSAIDs to seek medical attention immediately if they experience symptoms such as chest pain, shortness of breath or trouble breathing, weakness in one part or side of their body, or slurred speech.

NSAIDs are widely used to treat pain and fever from many different long- and short-term medical conditions such as arthritis, menstrual cramps, headaches, colds, and the flu. NSAIDs are available by prescription and OTC. Examples of NSAIDs include ibuprofen, naproxen, diclofenac, and celecoxib (see Table 1 for a list of NSAIDs). The risk of heart attack and stroke with NSAIDs, either of which can lead to death, was first described in 2005 in the Boxed Warning and Warnings and Precautions sections of the prescription drug labels.

The FDA now recommends, the prescription NSAID labels reflect 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.
All NSAIDs may have a similar risk; the risk for heart attack or stroke is similar for all NSAIDs.
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.