Hepatotoxicity epidemiology and demographics
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Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Jesus Rosario Hernandez, M.D. [2]
Overview
Drug-related hepatotoxicity is generally considered as an uncommon complication for many drugs, with an incidence between 1 in 10,000 and 1 in 100,000.[1] The true incidence of drug-induced liver injury is hard to determine, partly because of difficulties in detection as well as lack of unified criteria for diagnosis.
Epidemiology
Drug-induced liver injury (DILI) has an approximate annual incidence between 10 and 15 per 10,000 to 100,000 persons. One study from France reported a crude annual incidence of 13.9 ± 2.4 per 100,000 inhabitants, which is 16 times greater than the number noted by spontaneous reporting to French regulatory authorities.[2] The true incidence of hepatic adverse events in the general population remains unknown and is often underestimated. More than a thousand drugs have been associated with DILI, the most common among them are antimicrobial agents and drugs work on the central venous system.[3]
It has been suggested that for every 10 cases of elevations in alanine aminotransferase (ALT) in a clinical trial, there will be at least one case of severe DILI that develops once the drug becomes widely available.[4][5]
References
- ↑ Sgro, C.; Clinard, F.; Ouazir, K.; Chanay, H.; Allard, C.; Guilleminet, C.; Lenoir, C.; Lemoine, A.; Hillon, P. (2002). "Incidence of drug-induced hepatic injuries: a French population-based study". Hepatology. 36 (2): 451–5. doi:10.1053/jhep.2002.34857. PMID 12143055. Unknown parameter
|month=ignored (help) - ↑ Chalasani, N.; Fontana, RJ.; Bonkovsky, HL.; Watkins, PB.; Davern, T.; Serrano, J.; Yang, H.; Rochon, J.; Chalasani, N. (2008). "Causes, clinical features, and outcomes from a prospective study of drug-induced liver injury in the United States". Gastroenterology. 135 (6): 1924–34, 1934.e1–4. doi:10.1053/j.gastro.2008.09.011. PMID 18955056. Unknown parameter
|month=ignored (help) - ↑ Maddur, H.; Chalasani, N. (2011). "Idiosyncratic drug-induced liver injury: a clinical update". Curr Gastroenterol Rep. 13 (1): 65–71. doi:10.1007/s11894-010-0154-8. PMID 21049293. Unknown parameter
|month=ignored (help) - ↑ Lewis, JH. (2006). "'Hy's law,' the 'Rezulin Rule,' and other predictors of severe drug-induced hepatotoxicity: putting risk-benefit into perspective". Pharmacoepidemiol Drug Saf. 15 (4): 221–9. doi:10.1002/pds.1209. PMID 16444771. Unknown parameter
|month=ignored (help)