Sertindole: Dilemmas for its use in clinical practice

Introduction: Sertindole was taken off the market by its manufacturer in 1998 due to concerns of its association with prolongation of QT intervals and serious dysrhythmia. After extensive post-marketing analysis and epidemiological studies regarding its safety, sertindole was relaunched in Europe in 2005. Areas covered: Sertindole is an efficacious antipsychotic that possesses superior efficacy compared with haloperidol, similar efficacy compared with risperidone, and slightly inferior efficacy compared with olanzapine. Sertindole has been shown in seven randomized, double-blind clinical trials to be a well-tolerated antipsychotic with placebo-level sedation and extrapyramidal symptoms. The long-term effectiveness and tolerability of sertindole was documented in a 52-week clinical trial. The United States Food and Drug Administration (FDA), however, has yet to accept the manufacturer's claims that sertindole reduces the risk of suicide and that it is safe for patients with schizophrenia. The safety concerns for sertindole, especially focusing on cardiac adverse events, are addressed through contemporary database search along with cross-reference check. Expert opinion: While it has been reapproved by the European Commission, concerns still exist regarding its association with prolongation of QT intervals and dysrhythmias. Moreover, a consensus has not yet been established for clinical practice. The most conservative clinical use of sertindole at this time should be only after at least one antipsychotic medication failure and with a clear benefit/risk evaluation.