S.R.Ahmad1, A.Trontell2, J.G.Beitz3, 1Division of Drug Risk Evaluation, Office of Drug Safety, CDER, FDA, Rockville, MD, 2DSRCS, ODS, CDER, FDA, 3DDRE, ODS, CDER, FDA
Background: In the United States, acetaminophen (paracetamol) is one of the most popular and safe drugs when used within the recommended dose range. However, acetaminophen is also one of the leading causes of poisoning exposures in the U.S. In 1999, the overall number of calls to poison control centers concerning acetaminophen exposures was 108, 102.
Objectives: The objective of this review is to determine the extent of acetaminophen-related poisoning in the U.S.
Methods: The Toxic Exposure Surveillance System or TESS is a poisoning surveillance database maintained by the American Association of Poison Control Centers (AAPCC) in cooperation with the majority of U.S. poison control centers. A review of the AAPCC's annual reports from 1995 to 1999 was done to determine the extent of poisoning in association with exposure to acetaminophen products.
Results: In the five-year review period, the overall number of calls to poison control centers concerning acetaminophen exposures declined slightly but the number of fatalities increased by nearly 100% from 76 in 1995 to 141 in 1999. Overall, acetaminophen related fatalities represented 16% of the total 873 fatalities that were reported in the TESS database in 1999. Approximately 50% of acetaminophen-associated fatalities occurred in individuals who took single-ingredient acetaminophen products which are available over-the-counter (OTC). The remaining fatalities occurred in individuals who took acetaminophen combination products including butalbital, or diphenhydramine, or aspirin or aspirin/caffeine, or narcotics namely hydrocodone, oxycodone, codeine or propoxyphene. Most of these combination products are prescription products. Of the 141 fatalities in association with acetaminophen reported to TESS in 1999, fifty-five percent or 77 of the cases had suicidal intent, and 8% were unintentional. Other or unknown reasons accounted for the remaining 37% of the cases. Overall, 37% of all acetaminophen exposures documented by TESS in 1999 occurred in children under 6 years old, 22% in children and adolescents between the ages of 6 and 19 years old, and 38% in adults over 19 years. Age was unknown in 3% of the acetaminophen exposures. Thirty-four percent of children up to the age of 19 years were taking adult formulations of acetaminophen. At least 22% of children under 6 years of age used adult formulations.
Conclusions: Acetaminophen remains an important cause of morbidity and mortality in the U.S.