title: [Acute hepatocytic necrosis during ketoconazole therapy for treatment of onychomycosis. National Foundation for Registry and Evaluation of Adverse Effects].
abstract: The imidazole derivative ketoconazole is approved in the Netherlands for treatment of local and systemic fungal infections. Despite the risk of major hepatic damage, this antimycotic drug is still being used in daily practice for the oral treatment of patients with onychomycosis. Since April 1986, 18 cases of relatively severe hepatic damage in the Netherlands were ascribed to the oral use of ketoconazole for the treatment of onychomycosis, skin infection or vaginal candidiasis. Given the potential risk for the patients concerned, ketoconazole should no longer be prescribed for relatively mild cosmetic disorders such as onychomycosis.
authors.affiliation: Stichting Landelijke Registratie Evaluatie Bijwerkingen, Hertogenbosch.
authors.forename: E P
authors.initials: EP
authors.lastname: Van Puijenbroek
authors.forename: H J
authors.initials: HJ
authors.lastname: Metselaar
authors.forename: P H
authors.initials: PH
authors.lastname: Berghuis
authors.forename: P E
authors.initials: PE
authors.lastname: Zondervan
authors.forename: B H
authors.initials: BH
authors.lastname: Stricker
mesh_terms: D000293:Adolescent; D000328:Adult; D016907:Adverse Drug Reaction Reporting Systems / Q000706:statistics & numerical data; D000368:Aged; D000935:Antifungal Agents / Q000009:adverse effects*; D056486:Chemical and Drug Induced Liver Injury / Q000209:etiology* / Q000401:mortality; D005260:Female; D006801:Humans; D015994:Incidence; D007654:Ketoconazole / Q000009:adverse effects*; D008099:Liver / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009336:Necrosis; D009426:Netherlands; D014009:Onychomycosis / Q000150:complications / Q000188:drug therapy*; D015996:Survival Rate
chemical_list: D000935:Antifungal Agents; D007654:Ketoconazole
vernacular_title: Acute levercelnecrose bij gebruik van ketoconazol tijdens de behandeling van onychomycose.