title: Hepatic and haematological adverse reactions associated with the use of multidrug therapy in leprosy--a five year retrospective study.
abstract: This study analyses retrospectively some of the risks associated with the use of WHO-multidrug therapy (MDT) in Sri Lanka. Case records of 3,333 new cases of leprosy attending the Central Leprosy Clinic in Colombo during 1991-1995, were analysed for adverse drug reactions involving the liver and blood. There were 81 reports of suspected hepatic or haematological adverse reactions associated with the use of MDT, of which 39 were classified as haemolytic anaemia, 25 as toxic hepatitis, 2 as methaemoglobinaemia and 15 as anaemia. Dapsone, was incriminated in the majority of adverse reactions (72%). Adverse drug reactions were more common in female than male subjects (55% vs 45%; P < 0.5), but there was no significant differences between the age groups. Majority of adverse reactions was seen within the first three months of initiation of MDT. This study in no way undermines the benefits of MDT but highlights the risks and suggests measures to minimize these risks.
authors.affiliation: National Drug Quality Assurance Laboratory, Norris Canal Road, Colombo 10, Sri Lanka.
authors.forename: S I
authors.initials: SI
authors.lastname: Kaluarachchi
authors.forename: B M
authors.initials: BM
authors.lastname: Fernandopulle
authors.forename: B P
authors.initials: BP
authors.lastname: Gunawardane
mesh_terms: D000293:Adolescent; D000328:Adult; D000740:Anemia / Q000139:chemically induced / Q000453:epidemiology*; D056486:Chemical and Drug Induced Liver Injury / Q000453:epidemiology*; D002648:Child; D002991:Clofazimine / Q000009:adverse effects; D003622:Dapsone / Q000009:adverse effects; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D007917:Leprostatic Agents / Q000009:adverse effects* / Q000627:therapeutic use; D007918:Leprosy / Q000188:drug therapy*; D008297:Male; D008708:Methemoglobinemia / Q000139:chemically induced / Q000453:epidemiology*; D008875:Middle Aged; D012189:Retrospective Studies; D012293:Rifampin / Q000009:adverse effects / Q000627:therapeutic use
chemical_list: D007917:Leprostatic Agents; D003622:Dapsone; D002991:Clofazimine; D012293:Rifampin