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Labeling and Other Changes for Acetaminophen

Bridget M. Kuehn

JAMA. 2009;302(4):369-371.

	Since this article does not have an abstract, we have provided the first 150 words of the full text and any section headings.

The US Food and Drug Administration (FDA) is working to reduce drug-induced liver damage with an initiative targeting the use of acetaminophen—the most common cause of such adverse events. The agency also is promoting research on genetic factors that may contribute to drug-related liver problems.

Drug-induced liver failure is a growing concern for the FDA. Cases of acute liver failure reported to the agency's Adverse Events Reporting System (AERS) have increased from 89 in 1995 to 404 in 2005, and acetaminophen is the drug most commonly implicated in such reports.

Reports of liver damage in patients taking too much acetaminophen have prompted the US Food and Drug Administration to take precautions to reduce such adverse events.

On May 27, the FDA released a report by an agency working group that recommended measures to reduce the incidence of liver damage among patients taking acetaminophen, including improved public education, . . . [Full Text of this Article]

ACETAMINOPHEN



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