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

BMJ 2001; 322 doi: (Published 19 May 2001) Cite this as: BMJ 2001;322:1207
  1. David M Coulter, heada,
  2. Andrew Bate, programme leader, signal research methodologyb,
  3. Ronald H B Meyboom, medical adviserb,
  4. Marie Lindquist, head of research and developmentb,
  5. I Ralph Edwards, director (ralph.edwards{at}
  1. a Centre for Adverse Reactions Monitoring and Intensive Medicines Monitoring Programme, Department of Preventive and Social Medicine, University of Otago, Dunedin, New Zealand
  2. b Uppsala Monitoring Centre, WHO Collaborating Centre for International Drug Monitoring, S-75320 Uppsala, Sweden
  1. Correspondence to: I R Edwards
  • Accepted 20 February 2001


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.


  • Funding None.

  • Competing interests None declared.

  • Accepted 20 February 2001
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