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FDA Strengthens NSAID Meds’ Label Warning

Lauren Fernandez1 year ago

The US Food and Drug Administration (FDA) has increased warnings of heart attack and stroke risk on the labels of nonaspirin nonsteroidal anti-inflammatory drugs (NSAIDs).

About the Updated Warning Labels

The FDA has increased already existing warnings on NSAIDs labels that the drugs may increase the risk for heart attack or stroke, according to an agency alert posted on July 9, 2015. reports that the FDA is now requiring all prescription and over-the counter NSAIDs– such as Advil, Aleve, and Motrin– to feature updated warnings on labels, reflecting the increased cardiovascular risk.

This label requirement comes in response to up-to-date safety information reviewed by the FDA, including observational studies, a large combined analysis of clinical trials, and other scientific publications. Prescription and over-the-counter NSAID labels already include information about the risk of heart attack and stroke involved with taking the drugs. After a joint meeting of the FDA’s Arthritis Advisory Committee and Drug Safety and Risk Management Advisory Committee, the FDA will now require NSAIDs to reflect updated warnings and statistics (see below), including risk involved with higher doses and prolonged use.

The FDA recommends that doctors and their patients remain alert for the adverse effects that NSAIDs can cause for the duration of use. Those taking the medication should seek immediate medical attention of they experience any chest pain, shortness of breath, difficulty breathing, weakness in one part or side of their body, and/or slurred speech. The FDA asks that patients and doctors report adverse events potentially related to NSAID use to the FDA MedWatch Safety Information and Adverse Event Reporting Program online, by fax at 1-800-FDA-0178, or by mail to the address on the pre-addressed form.

New NSAID Safety Information

NSAID labels will now be required to reflect updated research and information reviewed by the FDA:

  • Estimates of increased risk of serious cardiovascular thrombic events caused by NSAID range from 10 to 50 percent or more, depending on the drugs and doses.
  • Observational data indicates that risk increases within days of NSAID initiation, says the FDA. Some data indicates higher risk after prolonged NSAID use.
  • Observational data indicates that thrombic cardiovascular risk from NSAIDs is dose-related.
  • There is evidence that even healthy patients increase cardiovascular risk with NSAID use. However, patients with known cardiovascular disease had a higher “incidence of cardiovascular thrombic events due to their increased baseline rate,” says the FDA.
  • There is some scientific evidence to suggest that naproxen may have a lower cardiovascular risk compared to other NSAIDs like ibuprofen. 


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