Citation

Nourjah P, Ahmad SR, Karwoski C, Willy M. Pharmacoepidemiol. Drug Saf. 2005; 15(6): 398-405.

Affiliation

Office of Drug Safety, Division of Drug Risk Evaluation, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA.

Copyright

(Copyright © 2005, John Wiley and Sons)

DOI

10.1002/pds.1191

PMID

16294364

Abstract

OBJECTIVE: To estimate the number of acetaminophen-associated overdoses in the United States and identify possible risk factors for intervention. METHODS: The investigators obtained estimates of acetaminophen-associated overdoses using different national databases. Two emergency room databases, a hospital discharge database, a national mortality file, and a poison surveillance database were used to identify cases. The FDA's spontaneous reporting system was searched to identify possible root causes for overdoses. RESULTS: Analysis of national databases show that acetaminophen-associated overdoses account for about 56 000 emergency room visits and 26 000 hospitalizations yearly. Analysis of national mortality files shows 458 deaths occur each year from acetaminophen-associated overdoses; 100 of these are unintentional. The poison surveillance database showed near-doubling in the number of fatalities associated with acetaminophen from 98 in 1997 to 173 in 2001. AERS data describe a number of possible causes for unintentional acetaminophen-associated overdoses. CONCLUSIONS: Each year a substantial numbers of Americans experience intentional and unintentional acetaminophen-associated overdoses that, in severe cases, lead to serious illness and possible death. This summary of a series of analyses highlights the need for strategies to reduce this public health burden.