Medicines Sertindole

Sertindole was associated with 27 deaths (16 cardiac) in 2194 patients who were enrolled in premarketing studies further fatal cases have been collected, and the Committee on Safety of Medicines has described reports of 36 deaths (including some sudden cardiac deaths) and 13 serious but non-fatal dysrhythmias also associated with sertindole (4). 

EMEA. The European Agency for the Evaluation of Medicinal Products, http //www.emea.eu.int/pdfs/human/ referral/Sertindole/285202en.pdf... 

Sertindole was withdrawn from the market in 1998 because of a possible association with sudden or unexplained death [SEDA-26, 66]. After two observational studies did not confirm the risk, sertindole was approved in the EU in 2001, but the European Medicines Agency requested a large, postapproval commitment study to clarify the cardiac mortality risk. 

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