FDA Bolsters NSAID Warnings on Heart, Stroke Risk

FDA Strengthening Cardiovascular, Stroke Warnings for Rx NSAIDs
FDA Strengthening Cardiovascular, Stroke Warnings for Rx NSAIDs

Existing Warning for NSAIDS Strengthened

The FDA is strengthening an existing warning for NSAIDs (non-steroidal anti-inflammatory drugs) such as Advil (ibuprofen) and Aleve (naproxen) that a risk of heart attack or stroke can occur within weeks of taking the analgesic drugs and can increase the longer the medication is taken, as well as at higher doses.

In addition, NSAIDs can increase the risk of heart attack or stroke in patients with or without heart disease or risk factors for heart disease, the agency noted. However, patients with heart disease or risk factors for it have a greater likelihood of a cardiovascular event.

While the FDA said the changes will apply to prescription NSAIDs, it says it plans to extend the changes to over-the-counter NSAIDs as well. However, the cardiovascular warning does not apply to one kind of NSAID, aspirin.

Some NSAIDs likely carry a higher risk of heart attack and stroke than others, but the FDA said it is unclear at this point which ones are in the higher risk group.

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