Possible additional labeling requirements to ensure the safety of acetaminophen will be discussed by FDA’s Nonprescription Drugs Advisory Committee on Sept. 19.

The committee will meet together with members of other FDA advisory committees including Drug Safety & Risk Management, Anesthetic & Life Support Drugs, Cardiovascular & Renal Drugs, Arthritis and Gastrointestinal Drugs Advisory Committees.

Safety issues related to potential hepatotoxicity of both over-the-counter and prescription acetaminophen will be addressed by the committee.

FDA notes that although it "continues to believe that these ingredients are safe and effective for OTC use," the agency is seeking input on "whether labeling or other measures are warranted to reduce the risk of occurrences or the severity of these adverse reactions."

Moves by the British government to reduce acetaminophen overdose incidences were discussed by FDA at a February 2001 public meeting. Requirements that acetaminophen be sold in blister packs and limits on the amount of product that can be sold at one time are among the measures instituted in the UK.

The possibility of "flagging" combination cough/cold products containing acetaminophen also was addressed at the session in response to concerns that consumers may overdose by taking the pain killer in addition to a combination product already containing the analgesic.

On Sept. 20, the committee will discuss risk management approaches for aspirin and over-the-counter non-steroidal anti-inflammatory drugs.