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Incidence of drug-induced hepatic injuries: A French population-based study

Sgro, Catherine, Clinard, François, Ouazir, Kader, Chanay, Henry, Allard, Christian, Guilleminet, Christian, Lenoir, Claude, Lemoine, Alain, Hillon, Patrick·2002·Hepatology
DOI 10.1053/jhep.2002.34857
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Abstract

The incidence of hepatic adverse drug reactions (ADRs) remains unknown in the general population. The goal of this population-based study was to assess the incidence and seriousness of hepatic ADRs. All new cases of symptomatic drug-induced hepatic injuries were collected by 139 trained physicians (general practitioners [GPs] and specialists) between November 1997 and November 2000 in an area containing 81,301 inhabitants who could not go elsewhere for medical care. Over 3 years, 34 cases of hepatic ADRs were collected, 82% of them in outpatients. Global crude annual incidence rate was 13.9 ± 2.4 per 100,000 inhabitants; corresponding standardized annual global rate was 8.1 ± 1.5. There was no difference between urban and rural areas. Standardized incidence female/male ratio was 0.86 (0.26-2.90) until 49 years of age and 2.62 (1.00-6.92) after this age. Diagnosis was carried out by GPs in half of the cases. The outcome was recovery for 32 patients and death for 2. The main drugs implicated were anti-infectious, psychotropic, hypolipidemic agents, and nonsteroidal anti-inflammatory drugs (NSAIDs). Our results suggest that the number of hepatic ADRs in the French population would be 16 times greater than the number noted by spontaneous reporting to French regulatory authorities. In conclusion, the incidence and seriousness of drug-induced hepatitis are largely underestimated in the general population. These results may be useful for further evaluation of drug-induced hepatotoxicity.

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Crossref · 10.1053/jhep.2002.34857

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  • The estimated annual incidence of DILI in China (23.80 per 100,000) is higher than that reported from western countries.

    “the annual incidence in the general population was estimated to be 23.80 per 100,000 persons-higher than that reported from western countries.”

    From Incidence and Etiology of Drug-Induced Liver Injury in Mainland China (2019) · cites this paper as [9]

  • Two population-based studies in France and Iceland estimated annual incidences of DILI of approximately 13.9/100,000 and 19.1/100,000, respectively.

    “Two population-based studies conducted in France and Iceland estimated the annual incidences of DILI to be approximately 13.9/100,000 and 19.1/100,000 respectively.”

    From Incidence and Etiology of Drug-Induced Liver Injury in Mainland China (2019) · cites this paper as [9]

  • Females have been reported to have increased, unchanged, or even decreased incidence of DILI.

    “females have been reported to have increased, 8,26,27,31 unchanged, 9,30 or even decreased 12,21 incidence of DILI (Table 4).”

    From Incidence and Etiology of Drug-Induced Liver Injury in Mainland China (2019) · cites this paper as [9]

  • The estimated DILI incidence in mainland China (23.80 per 100,000) was higher than that estimated in Iceland (19.1/100,000), France (13.9/100,000), the United States (2.7/100,000), Spain (3.42/100,000) and Sweden (2.4/100,000).

    “which was still higher than that estimated in Iceland (19.1/100,000) 7 , France (13.9/100,000), 9 the United states (2.7/100,000), 10 Spain (3.42/100,000) 21 and Sweden (2.4/100,000) 22 (Table 4).”

    From Incidence and Etiology of Drug-Induced Liver Injury in Mainland China (2019) · cites this paper as [9]

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Research works printed but not linked: 12

  1. Pouyanne, 2000, Admissions to hospital caused by adverse drug reactions: cross sectional incidence study, BMJ, 320, 1036, 10.1136/bmj.320.7241.1036 · DOI
  2. Journal Officiel de la République Française. Lois et decrets 1995 3935 3938
  3. Benichou, 1990, Criteria of drug-induced hepatic disorders. Report of an international consensus meeting, J Hepatol, 11, 272, 10.1016/0168-8278(90)90124-A · DOI · Paper page
  4. Begaud, 1985, Unexpected or toxic drug reaction assessment (imputation): actualization of the method used in France, Therapie, 40, 111
  5. Perez Guthann, 1993, The increased risk of hospitalizations for acute liver injury in a population with exposure to multiple drugs, Epidemiology, 4, 496, 10.1097/00001648-199311000-00004 · DOI
  6. Lanza, 1995, Incidence of symptomatic liver function abnormalities in a cohort of NSAID users, Pharmacoepidemiology and Drug Safety, 4, 231, 10.1002/pds.2630040406 · DOI
  7. Dossing, 1982, Drug-induced liver disease in Denmark, Scand J Gastroenterol, 17, 205, 10.3109/00365528209182041 · DOI
  8. Bagheri, 2000, Detection and incidence of drug-induced liver injuries in hospital: a prospective analysis from laboratory signals, Br J Clin Pharmacol, 50, 479, 10.1046/j.1365-2125.2000.00282.x · DOI
  9. Minello, 1998, Mise en place d'un registre des hépatites virales B et C dans le département de la Côte d'Or. Methodologie, premiers résultats, Gastroenterol Clin Biol, 22, 766
  10. Lemozit, 1996, A comparative study of adverse drug reactions reported through hospital and private medicine, Br J Clin Pharmacol, 41, 166, 10.1111/j.1365-2125.1996.tb00177.x · DOI
  11. Conforti, 2000, Spontaneous reporting of drug-related hepatic reactions from two Italian regions (Lombardy and Veneto), Digest Liver Dis, 32, 716, 10.1016/S1590-8658(00)80336-9 · DOI
  12. Kando, 1995, Gender as a risk factor for adverse events to medications, Drugs, 1, 1, 10.2165/00003495-199550010-00001 · DOI

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Metadata

Authors
Sgro, C., Clinard, F., Ouazir, K., Chanay, H., Allard, C., Guilleminet, C., Lenoir, C., Lemoine, A., & Hillon, P.
Venue
Hepatology
Publisher
Ovid Technologies (Wolters Kluwer Health)
Published
2002-08
Volume
36
Issue
2
Pages
451-455
ISSN
0270-9139
DOI
10.1053/jhep.2002.34857
Cited by
716
References
0
Language
en
Licence
Funders
  • Reseau Hepatox
  • URCAM de Bourgogne, France

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