FDA Boosts Heart Attack, Stroke Warning for Pain Relievers

Life-threatening side effects can occur early
spilled pile of red tablets beside medicine bottle isolated on white

If you take more than the recommended dose of a non-aspirin pain reliever in the belief the medicine is harmless, there’s good reason now to pay close attention to the directions on the label.

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The Food and Drug Administration (FDA) strengthened warning label requirements for nonsteroidal anti-inflammatory drugs (NSAIDs), which include pain relievers such as ibuprofen and naproxen. These drugs are sold under brand names such as Motrin®, Advil® and Aleve®.

Some combination drugs that relieve various symptoms, such as multi-symptom cold medicine, also contain NSAIDs.

While the revamped warnings still say that NSAIDS may increase the chance for heart attack or stroke, new language will say that these serious, life-threatening side effects can occur as early as the first few weeks of use. In addition, the risk of heart attack or stroke might increase if you take NSAIDs for a longer time, the FDA says.

“There is no period of use shown to be without risk,” FDA spokeswoman Judy Racoosin, MD, MPH, said in a news release.

Aspirin also is an NSAID, but the revised warning doesn’t apply to aspirin.

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Important information

Should you stop taking NSAIDs for pain relief? For many people, the answer is no.

But people who have cardiovascular disease, particularly those who recently have had a heart attack or cardiac bypass surgery, are at the greatest risk for a heart attack or stroke associated with NSAIDs, the FDA says. If you have heart disease or high blood pressure, talk with your doctor before using an NSAID, the FDA says.

For those without cardiovascular issues, NSAIDs should continue to be safe, provided you take the recommended dose, says cardiologist Steven Nissen, MD.

“In particular, if you are someone with a low risk of heart disease, and you have back pain or arthritis pain and need these drugs to function, it’s reasonable to take them,” Dr. Nissen says. “But there is probably some increase in risk of heart disease and the public needs to be aware of that.”

Because many prescription and over-the-counter medicines contain NSAIDs, consumers also need to read labels carefully to avoid inadvertently taking too much of the pain reliever at once.

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Why the labeling change?

The new label requirements follow an FDA review of new safety information on prescription and over-the-counter NSAIDs that included observational studies, a large combined analysis of clinical trials, and other scientific publications.

Dr. Nissen says more and better research – in the form of randomized, controlled clinical trials — is needed to more fully understand who might be affected by NSAIDs and at what dosage level. Randomized, controlled clinical trials are the gold standard of proof in scientific research.

“But the FDA is being cautious, and that caution is reasonable,” Dr. Nissen says.

NSAIDs are still effective treatments for pain, inflammation and fever. However, you should carefully consider whether the drug is right for you, and use the medicine only as directed, Dr. Nissen says.

“What the public needs to know is that you should be aware of these risks,” Dr. Nissen says. “If you’re going to take these drugs, you should take them in the lowest dose that you can, for the least amount of time that you can.”

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