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Liver injury from nonsteroidal anti-inflammatory drugs in the United States.

Abstract

BACKGROUND & AIMS

Nonsteroidal anti-inflammatory drugs (NSAIDs) are commonly used and have been associated with hepatotoxicity. Studies of liver injury from NSAIDs have been retrospective and prospective data are lacking. The aim was to report the features and outcomes of the subjects with severe drug-induced liver injury from NSAIDS.

METHODS

The U.S. Drug Induced Liver Injury Network is a prospective registry of idiosyncratic drug hepatotoxicity. All patients are evaluated in a standard fashion and followed up for at least 6 months.

RESULTS

Of 1221 Drug Induced Liver Injury Network cases that were adjudicated, 30 cases were attributed to eight different NSAIDs. The mean age was 52 years old, 24 (80%) were women, and 21 (70%) were Caucasian. The mean latency was 67 days. Common signs and symptoms at presentation were nausea (73%), jaundice (67%) and dark urine (67%). Mean peak serum aspartate aminotransferase, alanine aminotransferase, total bilirubin and alkaline phosphatase were 898 U/L, 1060 U/L, 12.2 mg/dl and 326 U/L. The most common pattern of injury was hepatocellular (70%) and autoantibodies were detected in 33% of cases. Diclofenac, was the most frequently implicated NSAID (16/30 cases), and characterized by hepatocellular injury. Seventeen cases resulted in hospitalization or prolongation of hospitalization and one patient died from complications of Stevens-Johnson syndrome because of diclofenac.

CONCLUSIONS

Hepatocellular injury is the most common pattern seen with NSAID hepatotoxicity, and diclofenac is the most frequently implicated agent. Given the number of NSAID alternatives, diclofenac should be reserved for patients who fail other NSAIDs and a high level of suspicion for hepatotoxicity should be maintained.

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  • Authors+Show Affiliations

    ,

    Division of Hepatology, Carolinas Medical Center, Charlotte, NC, USA.

    ,

    Duke Clinical Research Institute, Duke University, Durham, NC, USA.

    ,

    National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, MD, USA.

    ,

    National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, MD, USA.

    ,

    Division of Gastrointestinal and Liver Diseases, University of Southern California, Los Angeles, CA, USA.

    ,

    Department of Medicine, University of Michigan School of Medicine, Ann Arbor, MI, USA.

    ,

    Division of Hepatology, Carolinas Medical Center, Charlotte, NC, USA.

    Source

    MeSH

    Adult
    Aged
    Aged, 80 and over
    Anti-Inflammatory Agents, Non-Steroidal
    Chemical and Drug Induced Liver Injury
    Female
    Humans
    Male
    Middle Aged
    Phenotype
    Prognosis
    Prospective Studies
    Registries
    Risk Factors
    Time Factors
    United States
    Young Adult

    Pub Type(s)

    Journal Article
    Multicenter Study
    Research Support, N.I.H., Extramural

    Language

    eng

    PubMed ID

    26601797

    Citation

    Schmeltzer, Paul A., et al. "Liver Injury From Nonsteroidal Anti-inflammatory Drugs in the United States." Liver International : Official Journal of the International Association for the Study of the Liver, vol. 36, no. 4, 2016, pp. 603-9.
    Schmeltzer PA, Kosinski AS, Kleiner DE, et al. Liver injury from nonsteroidal anti-inflammatory drugs in the United States. Liver Int. 2016;36(4):603-9.
    Schmeltzer, P. A., Kosinski, A. S., Kleiner, D. E., Hoofnagle, J. H., Stolz, A., Fontana, R. J., & Russo, M. W. (2016). Liver injury from nonsteroidal anti-inflammatory drugs in the United States. Liver International : Official Journal of the International Association for the Study of the Liver, 36(4), pp. 603-9. doi:10.1111/liv.13032.
    Schmeltzer PA, et al. Liver Injury From Nonsteroidal Anti-inflammatory Drugs in the United States. Liver Int. 2016;36(4):603-9. PubMed PMID: 26601797.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - Liver injury from nonsteroidal anti-inflammatory drugs in the United States. AU - Schmeltzer,Paul A, AU - Kosinski,Andrzej S, AU - Kleiner,David E, AU - Hoofnagle,Jay H, AU - Stolz,Andrew, AU - Fontana,Robert J, AU - Russo,Mark W, AU - ,, Y1 - 2015/12/15/ PY - 2015/09/08/received PY - 2015/11/10/accepted PY - 2015/11/26/entrez PY - 2015/11/26/pubmed PY - 2016/12/22/medline KW - diclofenac KW - hepatotoxicity KW - medication KW - nonsteroidal SP - 603 EP - 9 JF - Liver international : official journal of the International Association for the Study of the Liver JO - Liver Int. VL - 36 IS - 4 N2 - BACKGROUND & AIMS: Nonsteroidal anti-inflammatory drugs (NSAIDs) are commonly used and have been associated with hepatotoxicity. Studies of liver injury from NSAIDs have been retrospective and prospective data are lacking. The aim was to report the features and outcomes of the subjects with severe drug-induced liver injury from NSAIDS. METHODS: The U.S. Drug Induced Liver Injury Network is a prospective registry of idiosyncratic drug hepatotoxicity. All patients are evaluated in a standard fashion and followed up for at least 6 months. RESULTS: Of 1221 Drug Induced Liver Injury Network cases that were adjudicated, 30 cases were attributed to eight different NSAIDs. The mean age was 52 years old, 24 (80%) were women, and 21 (70%) were Caucasian. The mean latency was 67 days. Common signs and symptoms at presentation were nausea (73%), jaundice (67%) and dark urine (67%). Mean peak serum aspartate aminotransferase, alanine aminotransferase, total bilirubin and alkaline phosphatase were 898 U/L, 1060 U/L, 12.2 mg/dl and 326 U/L. The most common pattern of injury was hepatocellular (70%) and autoantibodies were detected in 33% of cases. Diclofenac, was the most frequently implicated NSAID (16/30 cases), and characterized by hepatocellular injury. Seventeen cases resulted in hospitalization or prolongation of hospitalization and one patient died from complications of Stevens-Johnson syndrome because of diclofenac. CONCLUSIONS: Hepatocellular injury is the most common pattern seen with NSAID hepatotoxicity, and diclofenac is the most frequently implicated agent. Given the number of NSAID alternatives, diclofenac should be reserved for patients who fail other NSAIDs and a high level of suspicion for hepatotoxicity should be maintained. SN - 1478-3231 UR - https://www.unboundmedicine.com/medline/citation/26601797/Liver_injury_from_nonsteroidal_anti_inflammatory_drugs_in_the_United_States_ L2 - https://doi.org/10.1111/liv.13032 DB - PRIME DP - Unbound Medicine ER -