BMJ 2001;322:1207-1209 ( 19 May )

Papers

Antipsychotic drugs and heart muscle disorder in international pharmacovigilance: data mining study

David M Coulter, head, ^a Andrew Bate, programme leader, signal research methodology, ^b Ronald H B Meyboom, medical adviser, ^b Marie Lindquist, head of research and development, ^b I Ralph Edwards, director. ^b

^a Centre for Adverse Reactions Monitoring and Intensive Medicines Monitoring Programme, Department of Preventive and Social Medicine, University of Otago, Dunedin, New Zealand, ^b Uppsala Monitoring Centre, WHO Collaborating Centre for International Drug Monitoring, S-75320 Uppsala, Sweden

Correspondence to: I R Edwards ralph.edwards{at}who-umc.org

Objectives: To examine the relation between antipsychotic drugs and myocarditis and cardiomyopathy.
Design: Data mining using bayesian statistics implemented in a neural network architecture.
Setting: International database on adverse drug reactions run by the World Health Organization programme for international drug monitoring.
Main outcome measures: Reports mentioning antipsychotic drugs, cardiomyopathy, or myocarditis.
Results: A strong signal existed for an association between clozapine and cardiomyopathy and myocarditis. An association was also seen with other antipsychotics as a group. The association was based on sufficient cases with adequate documentation and apparent lack of confounding to constitute a signal. Associations between myocarditis or cardiomyopathy and lithium, chlorpromazine, fluphenazine, haloperidol, and risperidone need further investigation.
Conclusions: Some antipsychotic drugs seem to be linked to cardiomyopathy and myocarditis. The study shows the potential of bayesian neural networks in analysing data on drug safety.

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