FDA Strengthening Cardiovascular, Stroke Warnings for Rx NSAIDs

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.


Jonathan Block

Jonathan Block

Jonathan Block is an associate editor at BioCentury, which provides news and information about the biotechnology and pharmaceutical industries. Prior to joining BioCentury in 2019, Jonathan worked for MedShadow as content editor. He has been an editor and writer for multiple pharmaceutical, health and medical publications, including The Pink Sheet, Modern Healthcare, Health Plan Week and Psychiatry Advisor. He holds a BA from Tufts University and is earning an MPH with a focus on health policy from the CUNY Graduate School of Public Health & Health Policy.


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