NSAID Heart Attack, Stroke Risk Results in Stronger Warnings for Advil, Other OTC Painkillers

Federal drug regulators are strengthening the warning labels for certain popular painkillers, including Advil, Aleve and other nonsteroidal anti-inflammatory drugs (NSAIDs), indicating that users may face an increased risk of heart attacks and strokes. 

According to a drug safety communication issued by the FDA on July 9, both over-the-counter (OTC) and prescription strength NSAID medications will be required to carry the stronger warnings.

Some of the most widely used OTC painkillers are NSAIDs, such as Advil, Aleve and Motrin. These drugs already a black box label warning on heart attack and stroke risks, but the FDA will now require additional information on the label.

The NSAID heart warnings will include indication that the risk of heart attack and stroke can occur as early as a few weeks of using one of the drugs, and that risk may increase the longer NSAIDs are taken. Higher doses also appear to increase the health risks, the FDA warned.

The FDA found that NSAIDs can increase the risk of a heart attack or stroke in both patients who suffer from heart disease or carry heart disease risk factors, and those who do not. However, patients with heart disease or the risk factors appear to be at the greatest risk.

The agency believes that new information suggests that the risk is different depending on the drug. However, the information is not sufficient enough for the FDA to single out which NSAIDs carry the higher risk at this time, so FDA reviewers are not singling out any particular brand.

On a new consumer update page, the FDA warns consumers to avoid taking multiple NSAIDs at once, and warns that consumers may be unaware that some prescription drugs contain NSAIDs. The FDA urges consumers to check the labels of drugs they are taking to be aware of which contain NSAIDs to avoid accidentally increasing the risks.

All NSAIDs first received a boxed warning, the strongest label warning the FDA can require, on heart attacks and strokes in 2005. The new warnings come from more recent information showing that the risk can occur within weeks of first taking one of the drugs.

“There is no period of use shown to be without risk,” Dr. Judy Racoosin, deputy director of FDA’s Division of Anesthesia, Analgesia, and Addiction Products, said in the consumer update. “Everyone may be at risk — even people without an underlying risk for cardiovascular disease.”