FDA Bolsters Warnings of Heart Attack, Stroke Risks for NSAID Pain Relievers

Nearly 30 million Americans regularly take over-the-counter ibuprofen, naproxen or similar drugs for pain, which are described as “nonsteroidal anti-inflammatory drugs” or NSAIDs.

Now, the U.S. Food and Drug Administration has strengthened an existing warning of possible heart attack and stroke risks for people who use these NSAIDs.

The FDA said it is intensifying its “Drug Facts” labels to indicate that NSAIDs can increase the chance of a heart attack or stroke, either of which can lead to death. And those serious side effects can occur as early as the first few weeks of using an NSAID, the new warning states. The risk might rise the longer people take NSAIDs, the FDA states. (Although aspirin is also an NSAID, this revised warning doesn’t apply to aspirin.)

The warning covers drugs such common NSAIDs as ibuprofen, sold under brand names like Advil or Motrin; naproxen (Aleve), as well as prescription arthritis drugs known as COX-2 inhibitors, such as Celebrex. Tylenol, known generically as acetaminophen, is not an NSAID.

Language on these pills currently warns that they can increase the risk of heart-related problems if used long term.

“In general, patients with heart disease or risk factors for it have a greater likelihood of heart attack or stroke,” the agency notes in the announcement posted to its website.

The FDA also tells consumers to be careful not to take more than one product that contains an NSAID at a time.

Anyone concerned about the side effects of these over-the-counter NSAIDS should consult their physician, especially if they are at risk for heart attacks or strokes.

The FDA added a boxed warning to prescription drug labels about this same risk in 2005. But more recent data and information are prompting the FDA to update NSAID labeling.

“Today, we know that the risk of heart attack and stroke may occur early in treatment, even in the first weeks,” the FDA states.