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Cited by 12Drug-Induced Hepatotoxicity and ProtectionPharmacovigilance and Adverse Drug ReactionsPharmacogenetics and Drug Metabolism

Answers to the Most Common Questions About the Hepatic Safety Profile of Duloxetine

Wohlreich, Madelaine M., Acharya, Nayan, Strombom, Indiana, Kuritzky, Louis, Robinson, Michael, Heinloth, Alexandra N., Regev, Arie, Wernicke, Joachim F.·2008·Postgraduate Medicine
DOI 10.3810/pgm.2008.07.1803
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Abstract

Since its first FDA approval in 2004, duloxetine has been taken by more than 5 million patients. A small fraction of patients treated with duloxetine develop elevations in liver enzymes, which generally resolve spontaneously without any change in treatment. Very rare cases (estimated 1-2 per 100,000 exposures) of idiosyncratic hepatic toxicity have been reported in patients taking duloxetine, particularly in those with substantial alcohol use and/or preexisting liver disease. In the context of more than 23,000 patients exposed during clinical trials, and more than 1.5 million patient years of exposure subsequent to product launch, the hepatic risk after exposure to duloxetine appears to be within the range identified for other therapeutic agents. Therefore, it does not warrant hepatic enzyme monitoring. As with any medication, physicians should follow prescribing guidelines and educate patients on the risks and benefits of duloxetine.

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Crossref · 10.3810/pgm.2008.07.1803

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23 of 23 references verified0 citation errors · 0 not checkable

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  • Very rare cases (estimated 1 to 2 per 100,000 exposures) of idiosyncratic hepatic toxicity have been reported in patients, particularly in those with substantial alcohol use and/or preexisting liver disease.

    “Very rare cases (estimated 1 to 2 per 100,000 exposures) of idiosyncratic hepatic toxicity have been reported in patients, particularly in those with substantial alcohol use and/or preexisting liver disease.”

    From Comparative Efficacy and Harms of Duloxetine, Milnacipran, and Pregabalin in Fibromyalgia Syndrome (2010) · cites this paper as [68]

  • Postmarketing reports on the use of DLX for other indications have demonstrated that a small fraction of patients treated with DLX developed elevations in liver enzymes, which generally resolved spontaneously without any change in treatment.

    “Postmarketing reports on the use of DLX for other indications have demonstrated that a small fraction of patients treated with DLX developed elevations in liver enzymes, which generally resolved spontaneously without any change in treatment.”

    From Comparative Efficacy and Harms of Duloxetine, Milnacipran, and Pregabalin in Fibromyalgia Syndrome (2010) · cites this paper as [68]

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Authors
Wohlreich, M. M., Acharya, N., Strombom, I., Kuritzky, L., Robinson, M., Heinloth, A. N., Regev, A., & Wernicke, J. F.
Affiliations
  • Eli Lilly (United States) (US)
  • University of Florida (US)
Corresponding author
Wohlreich, Madelaine M.
ORCID
Venue
Postgraduate Medicine
Publisher
Informa UK Limited
Published
2008-01
Volume
120
Issue
2
Pages
111-118
ISSN
  • 0032-5481 (ISSN-L)
  • 1941-9260
DOI
10.3810/pgm.2008.07.1803
OpenAlex
W2005479352
Cited by
12
References
23
Citations by year
2013: 1 · 2012: 1
FWCI
3.04
Type
journal article
Language
en
Open access
closed
Locations
  • Postgraduate Medicine (publishedVersion)
  • PubMed (publishedVersion)
Topics
  • Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Pharmacology › Drug-Induced Hepatotoxicity and Protection
  • Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Toxicology › Pharmacovigilance and Adverse Drug Reactions
  • Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Pharmacology › Pharmacogenetics and Drug Metabolism
Keywords
duloxetine, hepatic safety, drug-induced liver injury, elevated liver enzymes, alcohol consumption, pre-existing liver disease, pharmacovigilance, antidepressants
MeSH terms
Duloxetine Hydrochloride, Antidepressive Agents, Depressive Disorder, Drug Labeling, Humans, Liver Diseases, Thiophenes, United States, Drug Approval, Risk Assessment, Chemical and Drug Induced Liver Injury

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