Warnings beefed up on OTC analgesics, antipyretics

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.

Ganley stated that products containing NSAIDs must now display the word “NSAID” in highlighted text alongside the name of its corresponding ingredient on all product packaging. Every OTC NSAID must also display a bolded warning about potential stomach bleeding on its label. Warnings about liver damage and stomach bleeding will be featured on both the outside packaging and the immediate container of each product containing acetaminophen and NSAIDs, respectively.

According to FDA, several manufacturers voluntarily implemented the new labeling after hearing the 2006 proposal; the bulk of OTC products affected by the final ruling are expected to be on shelves with updated labeling in the next 6 months, with variations depending on the time it takes for each manufacturer to implement graphics, packaging, and labeling change procedure. The press release cautioned that these previously-implemented voluntary changes to labeling do not necessarily address all of the labeling requirements in the new rule. For example, “the new rule includes a warning on products containing acetaminophen that instructs consumers to ask a doctor before they are taking the blood thinning drug warfarin.”
An FDA meeting scheduled for June 29–30 will address acetaminophen-related interventions and further strategies to reduce possible toxicity from acetaminophen-containing products.

Beth Farnstrom (bfarnstrom@aphanet.org)
Posted April 28, 2009