FDA to Change Heart Failure and Stroke Warnings on Painkillers

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Heart FailureThe U.S. Food and Drug Administration (FDA) is acting to strengthen the warnings on painkillers, such as ibuprofen, in light of new data that shows stronger links between heart attacks and strokes.

The targeted over-the-counter and prescription medications are non-aspirin members of a group called non-steroidal anti-inflammatory drugs, or NSAIDs. They include over-the-counter brand names like “Advil,” “Motrin IB,” and “Aleve.” In addition to being painkillers, these drugs are often used as antipyretics, meaning they reduce fever, and anti-inflammatories, meaning they reduce inflammation caused by minor injuries or conditions like sprains and arthritis.

Currently, the labels on NSAID drugs note they “may cause increased risk of heart attack and stroke.” The FDA’s change will rephrase the warning to state that the drugs “cause an increased risk of heart attack and stroke,” removing the word “may.” The new warnings will also note that the risk can occur shortly after beginning the medication and may rise the longer it is in use.

The “may increase” label warning originated in 2005, when the FDA first warned the public of the link between the use of NSAIDs and the increased risk of heart attack and stroke.

This new warning proposal comes after a panel of experts convened in 2014 to review recent studies and reports that suggest the link was both stronger than initially thought and that even those without underlying heart conditions could be at risk. Depending on the relative dose and the specific drug in use, the risk of heart failure or stroke rose at rates from as low as 10% to as high as 50%.

These new labeling changes are expected to be implemented over the coming months.

The Consumer Healthcare Products Association, a trade group for the manufacturers of over-the-counter medications, released a statement saying they would work with the FDA to implement the new changes.

Source for Today’s Article:
Tavernise, S., “F.D.A. Is Set to Toughen Nonaspirin Warnings,” The New York Times web site, July 9, 2015; http://www.nytimes.com/2015/07/10/us/fda-is-set-to-toughen-nonaspirin-warnings.html?_r=0.