The Food and Drug Administration (FDA) is strengthening an existing label warning that non-aspirin nonsteroidal
anti-inflammatory drugs (NSAIDs) increase the chance of a heart attack or stroke. Based on our comprehensive
review of new safety information, we are requiring updates to the drug labels of all prescription NSAIDs. 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. We will also request updates to the OTC non-aspirin
NSAID Drug Facts labels. Patients taking NSAIDs should 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. Since then, we have
reviewed a variety of new safety information on prescription and OTC NSAIDs, including observational studies, a
large combined analysis of clinical trials, and other scientific publications. Prescription NSAID labels will be revised
to 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.
• 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.
FDA will request similar updates to the existing heart attack and stroke risk information in the Drug Facts labels of
OTC non-aspirin NSAIDs.
In addition, the format and language contained throughout the labels of prescription NSAIDs will be updated to
reflect the newest information available about the NSAID class. Patients and health care professionals should
remain alert for heart-related side effects the entire time that NSAIDs are being taken. We urge you to report side
effects involving NSAIDs to the FDA MedWatch program, using the information below (Contact FDA).
Report a Serious Problem to MedWatch: Complete and submit the report Online
. Download form
or call 1-800-
332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or
submit by fax to 1-800-FDA-0178.