Antipsychotic drugs and heart muscle disorder in international pharmacovigilance: Data Mining Study

Centre for Adverse Reactions Monitoring and Intensive Medicines Monitoring Programme, Department of Preventive and Social Medicine, University of Otago, Dunedin, New Zealand.
BMJ Clinical Research (Impact Factor: 14.09). 06/2001; 322(7296):1207-9. DOI: 10.1136/bmj.322.7296.1207
Source: PubMed


To examine the relation between antipsychotic drugs and myocarditis and cardiomyopathy.
Data mining using bayesian statistics implemented in a neural network architecture.
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.
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.
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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Available from: David M Coulter
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    • "Hypotheses of suspected ARs first highlighted in automated knowledge discovery, which remain after clinical review, are then communicated to industry/regulators and published as appropriate [54, 55]. However, the risk of distortion from undiscovered data quality problems and the difficulty of obtaining complete, detailed information on reported AR incidents mean that signals of suspected ARs often remain tentative, even after clinical review [56]. "
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    • "Fluphenazine, a phenothiazine derivative, is a neuroleptic drug used to treat psychoses such as schizophrenia and manic disorders (Iqbal et al., 2005). Fluphenazine has been significantly associated with myocarditis and cardiomyopathy (Coulter et al., 2001). As for the effect of the drug on cardiac rhythmicity, fluphenazine was identified as significant predictor for QT prolongation (Chong et al., 2003; Turbott et al., 1987) and is known to induce torsades de pointes (Crouch et al., 2003). "
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    • "Some studies have shown that atypical antipsychotics may be associated with an increased risk of QT prolongation as with typical antipsychotics (Ray et al., 2009). However, it may be that the mechanism underlying the association with SUD is not always related to the QT interval (Coulter et al., 2001; Glassman, 2005; Ha¨gg et al., 2001; Kang et al., 2000; Killian et al., 1999; Titier et al., 2005; Wetterling, 2001). Although treatment with antipsychotic drugs – particularly atypical antipsychotics – is an important therapeutic option, clinicians should carefully weigh up the benefits of drug treatments with the risks to the individual patient. "
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