PARACETAMOL - ACETAMINOPHEN

The Division of Drug Information (DDI) is CDER's focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation by FDA.

The Food and Drug Administration (FDA) held a public advisory committee meeting on June 29 and June 30, 2009 to discuss acetaminophen use in both over-the-counter (OTC) and prescription (Rx) products, the potential for liver injury, and potential interventions to reduce the incidence of liver injury.

FDA recognizes that acetaminophen is an important drug used to treat pain and fever in both OTC and RX products and is not seeking to remove it from the market. The risk of developing liver injury to the individual patient who uses the drug according to directions is very low. However, acetaminophen containing products are used extensively making the absolute number of liver injury cases a public health concern.

The Drug Safety and Risk Management Advisory Committee with the Anesthetic and Life Support Drugs Advisory Committee and the Nonprescription Drugs Advisory Committee provided the FDA with independent advice from outside experts. These recommendations are advisory in nature and the FDA is not bound to follow their recommendations. At this time, the FDA has not made any decisions regarding acetaminophen containing products, but is reviewing the recommendations of the advisory committee, all available safety and efficacy data as well as public input before making a final decision. Please consult your healthcare provider about the safe and effective use of both OTC and RX acetaminophen containing products.

If you would like to make a formal comment in regards to liver injury with the use of acetaminophen, please refer to the following link:
http://www.regulations.gov/fdmspublic/component/main?main=DocumentDetail&o=0900006480968c1a