FDA beefs up warnings for pain relievers such as Advil, Motrin Aleve: These NSAIDs ‘cause increased risk’ of heart failure, even in healthy adults


The Food and Drug Administration is strengthening warnings on some common pain relievers, saying they can significantly increase the risk of heart attack and stroke, even in healthy adults.

The FDA has completed a review of new safety information and now wants drug makers to change the warning labels on NSAIDs — nonsteroidal anti-inflammatory drugs — including widely used, over-the-counter and prescription medications such as Advil, Motrin, Ibuprofen, Aleve, Naprosyn and Celebrex.

The agency began warning people about the risk of heart attack and stroke with these medications in 2005, but after reviewing a number of studies that showed stronger evidence that these types of medications cause an increased risk for heart attack and stroke, they decided it was time to issue a more definitive warning.

The studies showed that the risk increased by 10% to 50%, depending on the type of drug and dosage. Those who are at most risk are people who have heart disease, especially those who recently had a heart attack or stroke. The risk is also present for people who have never had heart disease.

The warning labels on these drugs already indicate they might cause an increased risk of heart attack and stroke. But the FDA says new data reveals there is stronger evidence that there is an increased risk of heart attack and stroke from NSAIDS and therefore want the warning labels to be updated.

The warning label applies to both over-the-counter and prescription NSAIDs. Over-the-counter NSAIDs are used to treat pain or fever while prescription forms are used to treat more serious conditions like arthritis.



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