Making use of the Food and Drug Administration briefing documents to reconsider the safety of the antipsychotic sertindole
Sertindole (Serdolect in the world, Zerdol in Germany) is an atypical antipsychotic agent, schizophrenia. Sertindole side effects include cardiac problems as prolongation of QT interval, arrhythmia and sudden deaths (higher than for other atypical antipsychotics). The FDA analysis of SCoP, made public in April 2009, estimated the hazard ratio for sudden cardiac death with sertindole versus risperidone as 5.102 (95% CI 1.453 – 17.913). In April 2009 an FDA advisory panel voted 13-0 that sertindole was effective in the treatment of schizophrenia but 12-1 that it had not been shown to be acceptably safe.
Sertindole was never approved for use in the USA and was discontinued in the U.K., Australia and the New Zealand. Sertindole was approved in the European Union (and others counytries) in 2002 (
This manuscript is being released primarily for two reasons. First, the importance of accessing freely available FDA documents to obtain a more complete characterization of a drug’s safety and efficacy. Second, to alert patients and prescribers in other countries about the potential risks of sertindole.
- Making use of the Food and Drug Administration briefing documents to reconsider the safety of the antipsychotic sertindole. Sasich LD, Abi-Jaoude E. Ontario, Canada. September 2016. Download article complete here.