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Inflammopharmacology. 2010 Apr;18(2):47-55. doi: 10.1007/s10787-010-0036-6. Epub 2010 Mar 7.

FDA proposals to limit the hepatotoxicity of paracetamol (acetaminophen): are they reasonable?

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Department of Clinical Pharmacology, St Vincent's Hospital, Darlinghurst, NSW, 2010, Australia.

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  • Inflammopharmacology. 2010 Apr;18(2):57.


Hepatotoxicity from paracetamol is of great concern because of the considerable number of patients who develop severe toxicity from this drug. A group of senior medical practitioners, academics and scientists were brought together on June 29 and 30, 2009 by the Food and Drug Administration of USA (FDA) with the aim of providing advice on how to limit the number of cases of hepatotoxicity due to paracetamol in USA. The most contentious recommendations were the reduction in the dose of paracetamol to 650 mg and the elimination of prescription combination products of paracetamol and opiates. The first recommendation indicates that many members of the committee consider, despite much evidence to the contrary, that therapeutic doses of paracetamol (up to 4 g daily) are associated with a significant incidence of hepatotoxicity. The second recommendation, if accepted by FDA, will require major changes in the therapeutic use of paracetamol and opiates. Adoption of these two recommendations may lead to the increased use of NSAIDs with the potential of increasing incidence of NSAIDs-related adverse reactions.

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