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HEALTHLINE NEWS

Should Ibuprofen Be a Prescription Drug?

New study reaffirms cardiac risks of ibuprofen and other nonsteroidal anti-inflammatory drugs. Should over-the-counter sales of these medications be restricted?

ibuprofen

After a new study in Denmark linked ibuprofen and another common pain medication to an increased risk of cardiac arrest, one of the study authors called for restrictions on over-the-counter sales of these drugs.

Concerns about nonsteroidal anti-inflammatory drugs (NSAIDs) are not new.

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Previous studies have linked NSAIDs to increased risk of heart failure, heart attack or stroke, and irregular heart rhythm.

Dr. Mary Norine Walsh, medical director of heart failure and cardiac transplantation at St. Vincent Heart Center in Indianapolis, and president of the American College of Cardiology, said the new study expands on past research.

“It elucidates that sudden cardiac arrest is the mechanism of death, at least in [Denmark],” Walsh told Healthline. “And it adds to the data that we already have showing that this class of drug is bad with regard to mortality.”

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Walsh was not involved in the new study, which was published Mar. 15 in the European Heart Journal - Cardiovascular Pharmacotherapy.

Read more: Guide to over-the-counter anti-inflammatories »

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Cardiac risks

In the study, researchers reviewed the medical records of 28,947 people who had a cardiac arrest outside of the hospital in Denmark between 2001 and 2010.

They also collected data on all prescriptions for NSAIDs filled in the country during that time.

More than 3,000 people who had cardiac arrest — sudden loss of heart function — had taken an NSAID within 30 days before the event.

Use of any NSAID raised the risk of cardiac arrest by 31 percent, compared to a previous 30-day period without heart problems.

Diclofenac — which is available in the United States only as a prescription — was linked to a 50 percent increased risk of cardiac risk and prescription-strength ibuprofen with a 31 percent greater risk.

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Naproxen, rofecoxib, and celecoxib were not associated with cardiac arrest. The researchers say that this could be because these drugs are seldom prescribed in Denmark and were not represented equally in the study.

The results serve as a reminder that NSAIDs are not harmless, even though some are available over-the-counter without a prescription.

“NSAIDs should be used with caution and for a valid indication. They should probably be avoided in patients with cardiovascular disease or many cardiovascular risk factors,” study author Gunnar H. Gislason, professor of cardiology at Copenhagen University Hospital Gentofte in Denmark, said in a press release.

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Read more: Ibuprofen vs. naproxen »

Restricting NSAIDs

Given the cardiac risks, Gislason also suggested that restrictions be placed on the over-the-counter sale of these drugs.

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“I don't think these drugs should be sold in supermarkets or petrol stations where there is no professional advice on how to use them,” said Gislason. “Over-the-counter NSAIDs should only be available at pharmacies, in limited quantities, and in low doses.”

In the United States, ibuprofen (such as Advil and Motrin) and naproxen (such as Aleve) are both available over-the-counter, but in lower doses than prescription NSAIDs.

According to the Cleveland Clinic, heart problems caused by NSAIDs can happen within a few weeks of use, and are more likely to occur with larger doses and long-term use.

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Over-the-counter NSAIDs should only be available at pharmacies, in limited quantities, and in low doses.
Gunnar H. Gislason, Copenhagen University Hospital Gentofte

The new study, though, looked only at prescription NSAIDs, so not everyone agrees with the need for restricting the sale of these drugs.

“Their data doesn’t address ibuprofen at lower doses because they couldn’t track it,” said Walsh. “So I’m not sure that’s the best recommendation.”

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People also have other non-NSAID options for pain relief.

“Acetaminophen is a very good pain medication for mild pain,” said Walsh. “It is not an anti-inflammatory. It doesn’t have a longer half-life that some of the over-the-counter NSAIDs have. But acetaminophen is a very good pain medication.”

Dr. Talal Attar, an interventional cardiologist and an assistant professor of clinical internal medicine at The Ohio State University Wexner Medical Center, said that over-the-counter NSAIDs can be used safely.

With a young and healthy individual who just sprained an ankle and has to take something for three or four days … it’s probably reasonable to have access to those drugs over-the-counter.
Dr. Talal Attar, Wexner Medical Center

“With a young and healthy individual who just sprained an ankle and has to take something for three or four days,” Attar told Healthline, “I think the risk of causing a cardiovascular event — although not zero — is low enough that it’s probably reasonable to have access to those drugs over-the-counter.”

The Cleveland Clinic recommends that people use over-the-counter NSAIDs for no more than three days for fever and 10 days for pain.

Any longer than that — of if you have a history of, or risk factors for, cardiovascular disease — and you should talk to your doctor first.

Attar also suggests that people taking regular prescription medications for high blood pressure, heart disease, diabetes, or other conditions be careful when using over-the-counter NSAIDs.

“I think it’s prudent to speak to your pharmacist or your physician any time you take something over-the-counter — whether it is an NSAID or anything in general — because of the risk of interfering with that medication,” Attar said.

People with chronic pain — who often use pain medications long-term — can work with their doctor to balance the risks and benefits of NSAIDs.

“It’s a shared decision between the patient and the doctor,” said Walsh. “If your pain is severe enough and one of these agents has been beneficial for your condition — such as a bad arthritis — it may be something that you want to consider.”

Read more: Ibuprofen vs. acetaminophen »

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