FDA Strengthens Stroke and Heart Attack Warnings on NSAIDs


You can find many NSAIDs like ibuprofen and naproxen over the counter as products such as Motrin and Aleve. (Photo: Getty Images)

Lots of us pop pain relievers like ibuprofen as needed, thinking they’re virtually harmless — but that’s really not the case, according to new word from the FDA. On Thursday, the agency announced plans to beef up existing heart attack and stroke warnings for both over-the-counter and prescription nonsteroidal anti-inflammatory drugs (NSAIDs).


NSAIDs are used to treat everything from occasional aches and pains to chronic conditions like rheumatoid arthritis and gout. You can find many NSAIDs like ibuprofen and naproxen over the counter as products such as Motrin and Aleve.

The FDA wants to issue a big reminder that from the first weeks you begin using an NSAID, there’s an increased chance of heart attack and stroke. These risks apply to everyone, whether you’re already prone to other cardiovascular events or not.

Why now?

There are probably two reasons we’re seeing a stronger FDA advisory now, says Prashant Vaishnava, a cardiologist at Mount Sinai Heart of the Mount Sinai Hospital and an assistant professor of medicine of Icahn School of Medicine at Mount Sinai.

“We’re better understanding the mechanism behind why there’s an increased risk of cardiovascular events, and that’s likely the inhibition of the COX-2 enzymes,” Vaishnava tells Yahoo Health. “The other reason is there’s a new focus on over-the-counter medications, which lots of people take without being fully aware of the risk.”

The risks are widespread — something we’re finding out more and more with research. Take for example a huge Lancet analysis of more than 600 studies and 350,000 people, which showed that significant doses of these medications daily can increase your risk of a cardiovascular event by up to a third.

And a survey of evidence published in the BMJ in 2011 concluded there was little data to suggest that any NSAIDs were notably safe for the heart (although naproxen did seem to be the least harmful, in cardiovascular terms).

What’s next, and how to take NSAIDs safely

While there’s already a note about heart attack and stroke risk on current NSAID labels, the FDA will request that manufacturers begin to roll out more-detailed instructions on the potential for complications. Expect to see additional warnings on labels and within the “Drug Facts.”

Vaishnava says it’s always smart to consult with your doctor before taking a new medication — even an over-the-counter pill like ibuprofen or naproxen. “Anyone with a history of coronary artery disease, heart attack, or bypass surgery especially shouldn’t take NSAIDs,” he says. “There’s good data showing it’s better to avoid these, and I always tell my patients to try acetaminophen [Tylenol] first if there is no contraindication to it.”

That said, acetaminophen has its own set of limitations. Vaishnava says its anti-inflammatory properties are limited, it can lead to liver toxicity at high doses, and it doesn’t always ease everyone’s pain symptoms. “Decisions about the use of OTC medications should be individualized,” he says.

If you’re not 100 percent sure what’s in a pain reliever or medication, read the label carefully. Don’t take multiple medications specifying the same active ingredient. “It’s also important to realize you may be taking an NSAID and not realize it, especially if you’re taking a combination pill,” like a multisymptom cold-relief medication, Vaishnava says.

Finally, be mindful of use. If an over-the-counter pain reliever isn’t actually working to improve your symptoms, stop taking it. And if you have symptoms of a heart issue while taking NSAIDs, like chest pain, difficulty breathing, or weakness in a part of the body, seek medical attention immediately.

(Note: Aspirin, while an NSAID, was not included in the new FDA warnings.)

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