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Heart Health, Explained

NSAIDs: Understanding the FDA's Updated Warning

The U.S. Food and Drug Administration recently issued a consumer update announcing the agency is strengthening an existing warning in prescription drug labels and over-the-counter drug facts labels to indicate that nonsteroidal anti-inflammatory drugs (NSAIDs) can increase the chance of heart attack or stroke, possibly leading to death. The change was announced in July and publicized by the New York Times on July 9, 2015.

Understanding the FDA's Strengthened NSAID Warning

Q: What is the current warning printed on packaging for nonsteroidal anti-inflammatory drugs? When was it first introduced? How is the FDA strengthening the warning?

Have you ever heard of the saying “too much of a good thing”? There are many examples in medicine of this quandary. Nonsteroidal anti-inflamatory drugs (NSAIDs) are a known effective treatment for a number of common maladies that have pain symptoms. Originally the FDA first introduced the warning for NSAIDs in 2005. The warning stated that NSAIDs increase the chance of a heart attack or stroke that can lead to death. The chance increases with longer use of the drugs and in people who have heart disease. The FDA is now strengthening the warning to state that the labels must at least include “the risk of heart attack or stroke can occur as early as the first weeks of using an NSAID. The risk may increase with longer use and higher dosages of NSAIDs.”

Q: What is the reason for the change?

The FDA recently reviewed new safety information prompting the update on the labeling for NSAIDs. A number of studies have shown an increased risk of heart attack and stroke in persons using NSAIDs. The risk likely varies depending upon the drug used and the dosage used. Increased risk ranges from 10% to 50% in some trials, depending on drugs and dosages studied. The FDA does not have enough information to suggest that the relative risk of a particular NSAID is higher or lower than another NSAID.

Q: Who is at the greatest risk? Does this warning apply to everyone or only those most vulnerable?

Patients with a previous history of heart attack and stroke appear to be at greater risk with NSAID use. It is unknown how much the risk increases, however usage of NSAIDs at higher dosages and longer durations likely increases the risk. The risk simply may be increased due to the higher baseline risk these patients have compared to those without a history of heart or stroke events. In addition, NSAIDs appear to increase the risk of heart failure and may exacerbate heart failure symptoms in those with a history of heart failure.

Q: How are NSAIDs used? What are some common medications? Are they all the same? What should consumers know about using multiple drugs containing NSAIDs?

NSAIDs are used to treat a wide variety of conditions such as arthritis, joint pains, colds and flu, headaches, and menstrual cramps. Higher doses usually require a prescription, and lower doses are available over-the-counter. Common names include generic ibuprofen, naproxen, and diclofenac or brand names such as Motrin, Advil, Celebrex, Naprosyn, Aleve, and Daypro. Ibuprofen and naproxen are commonly used in a number of over-the-counter combinations medications with cough and cold treatments or sleep aids.

Q: Why isn’t aspirin included in this revised warning?

Aspirin has been extensively studied as a preventive treatment, particularly in men, to reduce the chance of a first heart attack. In patients with history of heart attack or stroke, aspirin has been shown to be effective in reducing risk of future events. Aspirin is typically used at a lower dose (81mg) or what is called a “full” dose (324/325 mg), and there doesn’t appear to be any increased risk of blood clots at these dosages.

Q: What should consumers do with this new information? Should people still use NSAIDs?

If you are a patient with a history of heart disease or stroke and have a condition that requires treatment with an NSAID, using the lowest dose possible and for the shortest duration needed is recommended. In addition to the increased risk of blood clots, patients should be aware that chronic use of NSAIDs might interfere with aspirin’s protective benefits. A discussion with your physician about other possible medications or non-pharmacologic treatments for your pain condition would be appropriate. Consumers should be aware of this possible cause and effect relationship between NSAIDs and heart attack/stroke and promptly seek treatment for any signs or symptoms such as chest pain, shortness of breath, or stroke symptoms such as slurred speech or sudden weakness or numbness.

Q: When should someone stop taking an NSAID?

If you are a patient with a history of heart attack or stroke, or carry a higher risk factor profile such as diabetes, smoking history, high cholesterol or hypertension history, using these medications for this shortest duration and lowest dosage is best. The FDA recommendation states that NSAID use increases the risk of heart attack or stroke in patients with or without heart disease or in people with or without risk factors. This would suggest that using these drugs at the lowest dose possible and shortest duration in almost everyone seems prudent. If there is a history of a heart attack and stoke while starting a NSAID, these drugs should be avoided chronically.

HEALTH NEWS IN PERSPECTIVE

Answers to your questions on timely topics in cardiac care to help make sense of research reports in the media. The series includes questions on your heart and the effect of medications, exercise, diet, and hormones.

Team Specialist

James P. Bacon, MD, FACC Interventional Cardiology- Mansfield OhioHealth Healthcare System, Columbus, Ohio

Q&A Editor

Teresa Caulin-Glaser, MD, FACC, FAACVPR System Vice President, Heart & Vascular Services OhioHealth Healthcare System, Columbus, Ohio

Heart Health Explained is a collaboration of Women’s Health Research at Yale and the OhioHealth Healthcare System, a nationally recognized not-for-profit organization with providers across 46 counties, offering a holistic approach to prevention, treatment and rehabilitation of heart disease. OhioHealth is staffed by physicians, psychologists, nutritionists and nurses who answer the questions of the moment on heart and vascular health.

The information provided here may help you make more informed choices. However, it is not a substitute for an individualized medical opinion or diagnosis, and everyone should always consult with their personal physicians to make decisions about their condition or treatment.