title: Standardization of definitions and criteria of causality assessment of adverse drug reactions. Drug-induced cytopenia.
abstract: International reporting of adverse drug reactions to pharmaceutical manufacturers or authorities requires internationally accepted standard definitions of reactions and criteria for assessment of causality. Under CIOMS (Council for International Organizations of Medical Sciences) auspices, an international meeting organized by Roussel Uclaf pharmaceutical company in Paris in 1989 agreed on a series of standard designations of drug-induced liver disorders and criteria of causality assessment. The second such international meeting, on drug-induced cytopenia, held in Paris in April 1990, resulted in a series of proposed standard designations of the various forms of drug-induced cytopenia and criteria of causality assessment in respect of neutropenia, thrombocytopenia and aplastic anemia.
mesh_terms: D000380:Agranulocytosis / Q000139:chemically induced; D000741:Anemia, Aplastic / Q000139:chemically induced; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D006402:Hematologic Diseases / Q000139:chemically induced*; D006801:Humans; D007970:Leukopenia / Q000139:chemically induced; D009503:Neutropenia / Q000139:chemically induced; D013921:Thrombocytopenia / Q000139:chemically induced