FDA Strengthens Warning That Non-Aspirin NSAIDs Can Cause Heart Attacks or Strokes

As seen in the Consultant Connection September 2015 Issue
Source: FDA; July 9, 2015.
Changes Apply To Both Prescription and Over The Counter Drugs
The 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 a review of new safety information, the agency is requiring updates to the drug labels of all prescription NSAIDs.
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. Examples include ibuprofen, naproxen, diclofenac, and celecoxib.
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, the FDA has reviewed new safety information on prescription and non-prescription NSAIDs, including observational studies, a large combined analysis of clinical trials, and other scientific publications. These studies were also discussed at a joint meeting of the FDA’s Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee, held in February 2014.
Based on the FDA’s review and the advisory committees’ recommendations, 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 the FDA 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 after NSAID use than have patients without these risk factors because they have a higher risk at baseline.
  • Patients treated with NSAIDs after a first heart attack were more likely to die during the first year after the heart attack compared with patients who were not treated with NSAIDs after their first heart attack.
  • There is also an increased risk of heart failure with NSAID use
The FDA will request similar updates to the existing heart attack and stroke risk information in the Drug Facts labels of over-the-counter 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.

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