FDA Strengthens Warning on NSAIDs and Heart Risk

From the WebMD Archives

July 10, 2015 -- Popular painkillers like ibuprofen and naproxen have carried warnings for years about potential risks of heart attacks and strokes. This week, the FDA decided to strengthen those warnings on the medications, known as nonsteroidal anti-inflammatory drugs, or NSAIDs.

The warning includes both prescription and over-the-counter versions of drugs. It emphasizes that the risk applies to even short-term use of medications like Advil, Aleve, and Motrin. And it’s true for people with or without heart disease.

WebMD turned to three experts to sort out the issues.

Why is the FDA requiring stronger warning labels?

After looking at new safety information on both forms of the drugs, the FDA determined that the risks are greater than originally believed. The risk of heart attack and stroke can happen even in the first few weeks of using the drugs. And that risk is greater the higher the dose. These worse odds apply to people with or without a history of heart disease, the FDA says.

"They are not ruling out risk on a short-term basis," says Bill McCarberg, MD, a San Diego family physician who has published extensively on NSAIDs. The new warning, he says, "lets even occasional users know they are taking a risk."

While some NSAIDs may be less risky, the agency says the information it has now is not enough to rate individual drugs by risk level.

How do NSAIDs boost the risk of heart attacks and strokes?

"It has to do with how the medicines interact with the platelets," McCarberg says. Platelets are blood cells that help the blood clot and prevent bleeding.

The non-aspirin NSAIDs work in a different way than aspirin, says Mark Creager, MD, president of the American Heart Association.

"Aspirin as we know from many, many studies, is protective against heart attacks," he says. Aspirin prevents platelets from clumping together, which prevents the formation of dangerous clots that can block a vessel and cause a heart attack or stroke. The non-aspirin NSAIDs work on that enzyme, too, but also affect another enzyme that promotes clotting. That can lead to heart attacks and strokes.

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Is there any way to pick the ''safest'' NSAID?

"I would say all are associated with risk," Creager says. "But it is dose related. The more you use, the greater the risk. None of them are really safe. The adverse events can happen within weeks."

"It was previously thought that all NSAIDs may have a similar risk," says Judy Racoosin, MD, of the FDA's Center for Drug Evaluation and Research. Although newer information makes that less clear, they don’t know enough to say now one is safer over another.

“The increased risk most often occurs at higher doses, so use the lowest effective dose for the shortest possible time,” Racoosin says.

Does this mean I should never use an NSAID?

No, Creager says. "We overuse these drugs today, that's the problem," he says. "I think the message here is, 'Let's be prudent in who is using [NSAIDs] and for what.'"

"I think people need to realize there is risk in using these drugs, and along with their physician they need to assess the risk and benefit," Creager says.

Quality of life has to be considered, McCarberg says. If patients are in pain, he finds, ''they become less social and have more sleep disturbances."

The FDA also advises consumers to read labels to make sure they are not taking several medications that contain NSAIDs. Higher doses carry a higher risk.

What is a safer alternative to an NSAID?

"It depends on why the drug is being used," Creager says. People who are taking NSAIDs for a headache can turn to other medicines, such as migraine meds, he says.

Those taking NSAIDs for rheumatoid arthritis, an inflammatory condition, can go on other drugs, too, but those drugs also have risks, he says. Quality of life has to be part of the decision, he agrees.

The FDA says that all medicines have potential side effects. It says consumers should talk to their doctor for advice on what medicines are best.

If I take an NSAID, what warning signs should I watch out for?

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The FDA suggests you get medical attention right away if you notice any of the following:

  • Chest pain
  • Shortness of breath
  • Trouble breathing
  • Slurred speech
  • Weakness on one side or part of the body

What should I ask my doctor?

Talk to your doctor before you stop taking an NSAID, Racoosin says. Ask why you're taking the drug and if there are other options, the experts agree. Consider quality of life and how the medicine affects it. Take other risk factors, such as blood pressure and cholesterol levels, into account.

McCarberg reports advisory work for Iroko, Pfizer, Collegium, Millennium, Mallinckrodt, Inspirion, Salix, Takeda, Depomed, Janssen, Kaleo and AstraZeneca. He has stock holdings in: Johnson and Johnson, Protein Design Labs, Biospecifics Technologies, Nektar Therapeutics, Galena.

WebMD Health News Reviewed by Hansa D. Bhargava, MD on July 10, 2015

Sources

SOURCES:

Bill McCarberg, MD, family physician and pain specialist, San Diego.

Mark Creager, MD, president, American Heart Association; director, Heart and Vascular Center, Dartmouth-Hitchcock Medical Center.

FDA MedWatch, July 9, 2015.

Judy Racoosin, MD, MPH, deputy director for safety, Division of Anesthesia, Analgesia and Addiction Products, Center for Drug Evaluation and Research, FDA.

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