@ Medication Use

FDA announced the final ruling on new, more stringent packaging and warning label requirements for OTC pain relievers and fever reducers containing acetaminophen and NSAIDs at a briefing today. Internal analgesics, antipyretics and antirheumatic drug products are all affected by this ruling. Matthew Holman, PhD, Deputy Director, Division of Nonprescription Regulation Development, Office of Nonprescription Products, Office of New Drugs, Center for Drug Evaluation and Research (CDER), FDA; and Charles Ganley, MD, Director, Office of Nonprescription Products, Office of New Drugs, CDER, FDA, addressed press questions and spelled out the requirements, which were originally stated in December 2006. Manufacturers must comply with these requirements within a year of today’s date.

The new labeling would clearly identify products containing acetaminophen or NSAIDs on both the package and on the bottle and would warn consumers about the risk of stomach bleeding with NSAIDs and liver damage with acetaminophen, particularly when consumed with alcohol. The requirements would make consumers aware of acetaminophen and/or NSAID presence in OTC products such as Tylenol, Tylenol Children's, Excedrin PM, Alka-Seltzer Plus Cold & Sinus, Sudafed Sinus & Cold.

“Acetaminophen will be prominently displayed in highlighted text on all products containing acetaminophen,” Ganley said. He added that the drug facts panel on the outside of packaging, manufacturers will have to include a bolded warning about potential liver damage.