FDA Beefs Up NSAID Stroke and Heart Attack Warnings

Cautioning that they could increase the risk of stroke or heart attack, the Food and Drug Administration strengthened warning levels for popular painkillers such as naproxen and ibuprofen on Thursday.

The agency is mandating updates to the drug labels of all prescription NSAIDs, and requesting updates to OTC non-aspirin NSAID Drug Facts labels, which already contain information on heart attack and stroke risk.

Other non-aspirin NSAIDs include generic diclofenac and meloxicam.

The FDA noted that the elevated risk “most often occurs at higher doses.” Patients typically take these medications at lower doses and for shorter terms, and not for chronic conditions, said the Consumer Healthcare Products Association, which represents makers of over-the-counter versions of the drugs.

According to an FDA statement, the 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.