Advil, Aleve Raise Heart Attack Risk: FDA Warns

Greg Evans July 14th, 2015

The U.S Food and Drug Administration on Thursday strengthened the warning labels for widely used painkillers like ibuprofen and naproxen, saying they can increase the risk of heart attack or stroke.

The FDA is asking people to think carefully about their use of nonsteroidal anti-inflammatory drugs (NSAIDs), particularly if they’ve already had a heart attack, according to a consumer update on the agency’s website.

The agency said it is taking this action based on recent data that shows the risk of heart attack or stroke can increase even after using NSAIDs for a short time.

“They used to say they might cause risk of heart attack or stroke. Now we are saying they do cause increased risk of heart attack and stroke,” FDA spokesman Eric Pahon told NBC News.

In particular, people should avoid taking multiple products that contain NSAIDs, according to the revised FDA warning.

Common over-the-counter NSAIDs include ibuprofen (Motrin, Advil) and naproxen (Aleve), but NSAIDs also can show up in combination medicines like multi-symptom cold products.

“Be careful not to take more than one product that contains an NSAID at a time,” Dr. Karen Mahoney, deputy director of the FDA’s Division of Nonprescription Drug Products, said in the agency’s announcement.

People should check the list of active ingredients in the drug facts label if they aren’t sure whether a product contains an NSAID, she said.

Although aspirin is also an NSAID, the revised warning doesn’t apply to aspirin, the FDA said.

The agency will require drug manufacturers to include the updated warning on both prescription and over-the-counter brands of NSAIDs.

Over-the-counter NSAIDS are generally used to treat pain, inflammation and fever, while the stronger prescription brands are reserved for chronic and debilitating conditions like arthritis.

People with heart disease or high blood pressure should consult a doctor before using an NSAID, the FDA said.

However, the agency noted that the cardiovascular risk also is present in people without heart health problems.

“Everyone may be at risk — even people without an underlying risk for cardiovascular disease,” said Dr. Judy Racoosin, deputy director of the FDA’s Division of Anesthesia, Analgesia and Addiction Products.

The FDA first added a boxed warning to NSAID labels for the cardiovascular risk in 2005, after Merck & Co. pulled its popular pain reliever Vioxx off the market the year before. Vioxx, an NSAID, had been linked to heart attack and stroke.

Current labeling on over-the-counter NSAIDs warns patients to take the lowest dose possible for the least amount of time possible, and to not use them to treat pain for longer than 10 days.

“These medicines have a long history of safety and efficacy when used as directed,” the Consumer Healthcare Products Association, which represents nonprescription drug makers, said in a statement to the Associated Press. The group said it would cooperate with the FDA as it requests updates to the labels.


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