FDA Weighs Heart Risks of Naproxen

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FDA Weighs Heart Risks of Naproxen

News Review From Harvard Medical School

February 11, 2014

News Review From Harvard Medical School -- FDA Weighs Heart Risks of Naproxen

U.S. drug regulators are considering whether to dial back warnings about increased heart-attack risk for the pain reliever naproxen. But an advisory panel voted this week against the idea. Naproxen (Naprosyn, Aleve and others) is a nonsteroidal anti-inflammatory drug (NSAID). Others in this group include aspirin, ibuprofen (Motrin, Advil and others) and the prescription drug celecoxib (Celebrex). They relieve pain and inflammation and reduce fevers. But in the last 10 years evidence has built up that these drugs also may increase the risk of heart attack. The drug labels carry warnings about this risk. But a research analysis published last year suggested there was a lower risk of heart problems with naproxen than with other NSAIDs. So the Food and Drug Administration (FDA) said it would consider a label change for naproxen. A panel of expert advisers to the FDA evaluated the evidence. They voted, 16-9, not to change the heart risk warning. The FDA does not have to follow an expert panel's advice. However, it often does. HealthDay News wrote about the issue February 11.


By Howard LeWine, M.D.
Harvard Medical School


What Is the Doctor's Reaction?

For decades, it's been well known that pain relievers called nonsteroidal anti-inflammatory drugs (NSAIDs) can be hard on the stomach. Among others, the NSAIDs include:

  • Aspirin
  • Ibuprofen (Motrin, Advil, generic versions)
  • Naproxen (Naprosyn, Aleve, generic versions)

But 10 years ago, the discovery that an NSAID could increase your chance of a heart attack came as a complete surprise. Perhaps that's because aspirin is a type of NSAID. And it's standard practice to take aspirin for prevention and treatment of a heart attack.

The concerns started with Vioxx. In the fall of 2004, the drug maker Merck announced that Vioxx was linked to an increase in heart attack risk. This triggered a closer look at all of the medicines we reach for to ease pain, calm inflammation and cool fevers.

What followed cast a shadow on NSAIDs other than aspirin. At first, most of the heart attack risk was placed on drugs most similar to Vioxx, called COX-2 inhibitors. These were new types of NSAIDs that were supposed to be safer. And indeed they were easier on the stomach.

But soon after, all of the non-aspirin NSAIDs were suspected of increasing heart attack risk, especially in people with heart arteries already narrowed by fatty deposits. In 2005, the U.S. Food and Drug Administration (FDA) required a warning on all prescription and non-prescription NSAIDs. They included the very popular ibuprofen and naproxen.

As scientists began to gather more data, they found that naproxen might not have the same heart attack risk as other NSAIDs. This week an FDA panel of experts reviewed the findings. Most of them concluded that there was not enough evidence to say for certain that naproxen was safer than other NSAIDs.


What Changes Can I Make Now?

The safest way to help ease muscle or joint pain is a non-drug approach. Try heating pads, ice and physical therapy. Even if they don't completely do the trick, they may at least let you cut back on how often you take a pain reliever or how much you take.

If you are just looking for pain relief, try acetaminophen first. Acetaminophen kills pain in a different way than NSAIDs, so it doesn't increase heart attack risk. And it doesn't irritate the stomach. But acetaminophen does not calm inflammation. In high doses, acetaminophen can cause liver damage. A safe dose for most adults is no more than 3.25 grams per 24 hours (10 regular-strength Tylenol tablets per day).

If you also need to dampen inflammation, consider aspirin. Aspirin is good for the heart. But it can upset the stomach, lead to an ulcer and cause bleeding in the digestive system. If you need to take more than an occasional aspirin, check with your doctor about the right dose for you.

Cousins to aspirin, called non-acetylated salicylates, may be alternatives to aspirin. These include salsalate (Disalcid) and choline magnesium trisalicylate (Trilisate). They are easier on the stomach but lack aspirin's protection against heart attack and stroke. To get that, you would also need to take a daily baby aspirin.

Despite the current vote by the FDA panel of experts, the evidence does suggest that naproxen has a lower heart attack risk than other NSAIDs. But people with known heart disease, or at high risk of heart attack or stroke, should avoid any non-aspirin NSAID or at least use the lowest dose for the shortest time.

If you still prefer ibuprofen and also need a daily aspirin, take the aspirin first thing in the morning. Then wait at least 30 minutes before taking any ibuprofen. Ibuprofen can block the desired anti-clotting action of aspirin.


What Can I Expect Looking to the Future?

For now, the black box warning on drugs that contain naproxen will not change. And the full FDA is likely to accept the advice of the panel. Given the divided vote by the experts on the panel, this decision will certainly be questioned again in the future.

Even if the warning about heart attack risk is toned down, the black box warning regarding the risk of stomach irritation, ulcers and internal bleeding will remain the same.





Last updated February 11, 2014

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