News & Press: Patient Safety

NSAIDs: Drug Safety Communication - FDA Strengthens Warning of Chance of Heart Attack or Stroke

Tuesday, July 14, 2015  
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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 FDAs comprehensive review of new safety information, FDA is 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. FDA will also request updates to the OTC non-aspirin NSAID Drug Facts labels.

Read the MedWatch safety alert, including a link to the FDA Drug Safety Communication, HERE.

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