FDA Proposes Stronger Labeling Regulations for Common Painkillers

ROCKVILLE, Md. - The FDA has proposed to strengthen warning labels for common nonprescription painkillers to include safety information regarding the potential for stomach bleeding and liver damage.

The amended labeling regulations would apply to acetaminophen products such as Tylenol as well as NSAIDs such as aspirin, ibuprofen, naproxen and ketoprofen, the FDA said in a Dec. 19 news release.

The federal agency said it was concerned that consumers are not well informed about serious and potentially fatal complications from misusing the over-the-counter medications, although the risks are generally well-known to healthcare professionals.

In an effort to help ensure the …