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

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.

Adverse drug event monitoring at the Food and Drug Administration.

The Food and Drug Administration (FDA) is responsible not only for approving drugs but also for monitoring their safety after they reach the market. The complete adverse event profile of a drug is not known at the time of approval because of the small sample size, short duration, and limited generalizability of pre-approval clinical trials. This report describes the FDA's postmarketing surveillance system, to which many clinicians submit reports of adverse drug events encountered while treating their patients.