FDA proposes labeling changes to over-the-counter pain relievers, including potential for liver damage.

The FDA issued a proposal on Dec. 19 to amend the labeling regulations on over-the-counter (OTC) Internal Analgesic, Antipyretic, and Antirheumatic (IAAA) drug products to include important safety information regarding the potential for stomach bleeding and liver damage and when to consult a doctor. OTC IAAA drug products, commonly known as acetaminophen and nonsteroidal anti-inflammatory drugs (NSAIDs), such as aspirin, ibuprofen, naproxen and ketoprofen, are used to treat pain, fever, headaches and muscle aches.

The warnings for acetaminophen, sold as the brand name Tylenol and widely available as a generic drug under various store brand names, would highlight the potential for liver toxicity, particularly when using the drug in high doses, when taking more than one product with acetaminophen, and when taken with moderate amounts of alcohol.

Following the agency's announcement, Dr. Peter Lurie, deputy director of Public Citizen's Health Research Group issued a statement asking "what took the agency so long? In 1977, the FDA's Advisory Review Panel recommended the following warnings for acetaminophen-containing products: Do not exceed recommended dosage because severe liver damage may occur' and Do not exceed recommended dosage or take more than 10 days, because severe liver damage may occur.' For almost three decades, the FDA chose to ignore this wise advice."