An FDA advisory committee is recommending a stronger warning label for Acetaminophen, as it has recently been linked to 100 annual deaths in the United States from accidental overdoses.

Acetaminophen is one of the most commonly used painkillers in the U.S. In 2000, some 24 billion products containing Acetaminophen were sold. The 100-death estimate was presented at a recent FDA meeting, which is part of the Agency’s ongoing review of over-the-counter drugs to ensure drug safety, according to John Jenkins, Director of the FDA’s Office of New Drugs.

The new label would warn consumers about liver damage from overdoses and an informational leaflet would also be created for consumers.

Acetaminophen overdose is the leading cause of poisoning from swallowing drugs, according to FDA statistics. From 1993 to 1999, some 56,680 emergency room visits were linked to Acetaminophen overdoses; 25% of which were unintentional. Each year, such overdoses account for 13,036 emergency room visits, 2,189 hospitalizations and 100 deaths.

Acetaminophen overdoses are attributed to the following reasons, according to FDA staff members:

• The recommended dosage didn’t provide adequate pain relief.
• Two or more products containing Acetaminophen were inadvertently taken at the same time, such as Tylenol and NyQuil.
• Abuse of the 200 prescription products that combine a narcotic and Acetaminophen.
• Confusion about the appropriate dose because of differences in concentrations and formulations among products.

SOURCE: USA Today, September 19, 2002, www.usatoday.com.