FDA Regulation and Changes on Acetaminophen Labels

Over the last 10 years the Food & Drug Administration has implemented several changes in the labeling of acetaminophen to help regulate accidental overdoses.

- 1998 - FDA finalized a regulation that required all OTC acetaminophen products to include the following alcohol warning: "ALCOHOL WARNING: If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take acetaminophen or other pain relievers/fever reducers. Acetaminophen may cause liver damage."

- 2002 - FDA convened an Advisory Committee meeting to discuss unintentional liver toxicity related to the use of OTC acetaminophen. The Advisory Committee recommended a specific liver toxicity warning and distinctive labeling on OTC packages so that products containing acetaminophen could be more easily identified.

- early 2004 - FDA launched a public education campaign to help consumers use acetaminophen more safely.

- 2004 - FDA sent letters to every state board of pharmacy asking them to consider requiring labeling on the immediate container of Rx products containing acetaminophen that : (1) uses the term acetaminophen, not APAP, (2) instructs patients to avoid concurrent use of other acetaminophen containing drugs, (3) instructs patients not to exceed the maximum daily recommended acetaminophen dose, and (4) instructs petients to avoid drinking alcohol during prescription use. As of February 2008, no states had implemented regulations related to the request.

- 2006 - FDA issued proposed regulations for OTC labeling for acetaminophen containing products to require inclusion of new safety information and that the container adn outer carton identify acetaminophen when it is an ingredient. The final version of the regulation is currently under reveiw.

- 2009 - A meeting of The Drug Safety & Risk Management Advisory Committe recommended that all medicines containing acetaminophen must have it PROMINENTLY displayed on the container or outside carton if applicable. The product label contain new warnings that highlight the potential for liver toxicity and warn consumers against using more than the recommended dose of acetaminophen; using more than one product (over-the-counter or prescription) containing with acetaminophen, and taking acetaminophen with moderate amounts of alcohol.

It also advised that the product label contain a warning not to use acetaminophen with any other drug containing acetaminophen and to ask a doctor or pharmacist if persons are not sure whether a drug contains acetaminophen, a warning to ask a doctor before use if persons have liver disease, and a warning to ask a doctor or pharmacist before use if persons are taking the blood thinning drug warfarin. that the statement "see new warnings information" appears on the product's PDP for one year after the final rule is published.



Administration, U.S. Food and Drug. (2009, June 30). June 29-30, 2009: Joint Meeting of the Drug Safety and Risk Management Advisory Committee with the Anesthetic and Life Support Drugs Advisory Committee and the Nonprescription Drugs Advisory Committee: Meeting Announcement. Retrieved from http://www.fda.gov/advisorycommittees/calendar/ucm143083.htm
Administration, U.S. Food and Drug. (2009, May 1). Questions and Answers on Final Rule for Labeling Changes to Over-the-Counter Pain Relievers. Retrieved from http://www.fda.gov/Drugs/NewsEvents/ucm144068.htm