title: Reliability of data on haematotoxicity of antidepressants. A retrospective assessment of haematological monitoring in clinical studies on tricyclics.
abstract: At the present time, there is some concern over the haematological adverse effects of antidepressants. The present paper examines retrospectively 314 clinical trials in depression which were published in English or French between 1958 and 1986 and which used at least one of the following tricyclics: amitriptyline, clomipramine, imipramine. Two decision tables assess the depth of detail with which haematological monitoring and safety were described by the authors of each study. The results indicate that more than 98% of the papers under scrutiny either provide no information on the subject or do so in a manner which is entirely subjective. Thus, it seems that current knowledge of haematotoxicity of antidepressants is almost entirely the result of spontaneous reports from doctors, with its well-known drawbacks.
authors.affiliation: Groupe de Recherche en Pharmacovigilance, Paris, France.
authors.forename: M
authors.initials: M
authors.lastname: Girard
authors.forename: M
authors.initials: M
authors.lastname: Biscos-Garreau
mesh_terms: D000639:Amitriptyline / Q000009:adverse effects; D000929:Antidepressive Agents, Tricyclic / Q000009:adverse effects* / Q000627:therapeutic use; D001772:Blood Cell Count / Q000187:drug effects; D002986:Clinical Trials as Topic; D002997:Clomipramine / Q000009:adverse effects; D003866:Depressive Disorder / Q000188:drug therapy*; D006402:Hematologic Diseases / Q000139:chemically induced*; D006801:Humans; D007099:Imipramine / Q000009:adverse effects; D011358:Product Surveillance, Postmarketing; D012189:Retrospective Studies
chemical_list: D000929:Antidepressive Agents, Tricyclic; D000639:Amitriptyline; D002997:Clomipramine; D007099:Imipramine