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Stronger Warnings Ordered for Over-the-Counter Pain Relievers

By David Goguen on April 28, 2009 | Last updated on March 21, 2019

The manufacturers of popular over-the-counter pain relievers like Bayer Aspirin, Advil, Aleve, and Motrin will need to revise their drugs' labeling, to include warnings on health risks like internal bleeding and liver damage that have been linked to use of the medications.

The labeling change, which was announced Tuesday by the U.S. Food and Drug Administration (FDA), applies to all over-the-counter acetaminophen and nonsteroidal anti-inflammatory drugs (NSAIDs), which includes aspirin, ibuprofen, naproxen, and ketoprofen. Manufacturers of these non-prescription painkillers and fever reducers will need to comply with the label warning changes by April 2010.

In announcing the new labeling requirements, the FDA made clear that its goal is to help consumers use the medicines safely. The FDA News Release cites data which shows that "people sometimes take more acetaminophen than the labeling recommends," or "unknowingly take multiple products containing acetaminophen at the same time," which can raise the risk of for severe liver damage.

And as for NSAIDs, the risk of stomach bleeding is raised if blood-thinning drugs (anticoagulants) or steroids are taken alongside them, or if people take multiple NSAIDs at the same time. The new labeling changes will reflect these risks.

The FDA stresses that alcohol use alongside either acetaminophen or NSAIDs will increase the respective health risks linked to both types of medication.

Reuters reports that the new label warnings were first proposed in 2006, and "also apply to generic drugs and other nonprescription products that contain the painkillers such as cold medications."

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