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Pharmacoepidemiol Drug Saf. 2006 Jun;15(6):398-405.

Estimates of acetaminophen (Paracetomal)-associated overdoses in the United States.

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  • 1Office of Drug Safety, Division of Drug Risk Evaluation, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland 20993, USA. NOURJAHP@CDER.FDA.GOV



To estimate the number of acetaminophen-associated overdoses in the United States and identify possible risk factors for intervention.


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.


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.


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.

[PubMed - indexed for MEDLINE]
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