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FDA strengthens warning of link between NSAIDs and MI, stroke
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The FDA is strengthening a label warning of increased risk for MI or stroke associated with the use of nonsteroidal anti-inflammatory drugs, according to a safety announcement.
The labeling for all non-aspirin NSAIDs must be updated to reflect this change, the agency stated. The new warning follows an FDA review of safety data from observational studies, a combined analysis of clinical trials and other information on both prescription and over-the-counter NSAIDs. The Arthritis Advisory Committee and Drug Safety and Risk Management Advisory Committee reviewed these data in February 2014, according to the announcement.
The new labeling for prescription NSAIDs must reflect the following information, and the FDA will request similar updates to labeling for over-the-counter, non-aspirin NSAIDs, according to the announcement:
- MI and stroke risk can occur within weeks of beginning NSAID use, and may increase at higher doses and with longer duration of use.
- The risk for MI or stroke appears to be similar for all NSAIDs, but there is not sufficient information to definitively indicate a higher or lower risk with one NSAID over another.
- NSAID use can increase MI or stroke risk in patients regardless of whether they already have heart disease or risk factors for heart disease. However, the likelihood of MI or stroke is greatest among those with pre-existing disease or risk factors due to a higher baseline risk.
- Patients who received initial treatment with NSAIDs post-MI were more likely to die within 1 year than those who were not.
- HF risk is also elevated with NSAID use.
The agency also wrote that both patients and health care professionals should monitor for heart-related adverse events during NSAID use.