NEUROPSYCHIATRIC ADVERSE DRUG-REACTIONS - PASSIVE REPORTS TO HEALTH AND WELFARE CANADA ADVERSE DRUG REACTION DATABASE (1965-PRESENT)

Objective: Since 1965, Health and Welfare Canada has operated an adver se drug reaction (ADR) program. The program accepts spontaneous report s of adverse drug reactions, and maintains an ADR database. The purpos e of this article is to summarize the Psychiatric ADRs reported to thi s database since 1965. The nature of the information prohibits its use in the evaluation of epidemiological hypotheses about the etiology of drug-induced mental disorders. However, in an exploratory sense, the contents of the database may contribute to the development of epidemio logical hypotheses about the etiology of drug-induced mental disorders . Of particular interest are areas of apparent contradiction between t he contents of the database and the clinical literature. Methods: The database was searched for reports of ADRs to a group of drugs which ha ve been frequently implicated in causing psychiatric toxicity. All rep orts characterized as ''psychiatric disorders'' were down-loaded from the database for the analysis (n = 1822). The reports were further cla ssified into nine categories according to the type of psychiatric symp toms described. Results: There were several reports of hallucinations caused by methyldopa, and also several reports of benzodiazepine-induc ed hallucinations and encephalopathy. These reactions have not been de scribed in the literature. Also, there were few reports of digoxin-ind uced organic depression, and an absence of reports of organic mania in duced by H-2 blockers, despite descriptions of these sorts of reaction s in the clinical literature. Conclusions: Further research is needed to define the neuropsychiatric toxicity associated with medical drugs. Clinicians must continue to consider the potential role of medication s in the etiology of psychiatric symptoms.