WHO Pharmaceuticals Newsletter 1998, No. 03&04
(1998; 18 pages)
Table of Contents
Close this folderRegulatory actions
View the documentAluminium in total parenteral nutrition - labelling requirements & warning
View the documentAstemizole - warning concerning cardiovascular adverse events
View the documentBromfenac - warning label: liver damage
View the documentCarbamazepine - warning concerning precipitation
View the documentChlormezanone - withdrawn
View the documentCounterfeit drugs - warning to the public
View the documentDietary supplement "Sleeping Buddha" - warning concerning estazolam content
View the documentFenfluramine - withdrawn
View the documentHuman dura mater (freeze-dried) - restrictive measures
View the documentIsotretinoin - psychiatric adverse effects
View the documentPyrithione zinc (Skin-CapR) - withdrawn
View the documentSertindole - approval application withdrawn
View the documentTerfenadine - additional drug interactions
View the documentTerfenadine - withdrawn following approval of fexofenadine
Open this folder and view contentsDrug surveillance
Open this folder and view contentsNew developments
View the documentRecent approvals
Open this folder and view contentsMedical devices
Open this folder and view contentsGeneral information
Open this folder and view contentsVeterinary medicine
 

Sertindole - approval application withdrawn

Abbott, United States of America. Abbott Laboratories has voluntarily withdrawn its New Drug Application from the US Food and Drug Administration for the anti-schizophrenia agent, sertindole, licensed from H. Lundbeck A/S of Denmark.

In trials involving more than 2,000 patients up to June 1996, 27 patients died whilst receiving sertindole, including 13 sudden deaths. Although there was no proof that the drug actually caused these deaths, there was no explanation for them. Sertindole is known to induce QT interval prolongation in some patients. Other antipsychotics have been associated with QT interval prolongation, and sudden death has been associated with schizophrenia. Sertindole is safer and better tolerated than some other neuroleptics, e.g. it has low rates of extrapyramidal symptoms compared to haloperidol.

The company is carrying out further evaluation of clinical trials already under way, including a trial in treatment-resistant patients.

Sertindole has already been approved in 19 European countries and is marketed in 12 countries under the name SerdolectR. Lundbeck is conducting a pan-European Phase IV study involving 4,000 sertindole- prescribed patients with schizophrenia and 8,000 patients receiving other atypical anti-schizophrenia therapies.

Reference: Marketletter February 2, 1998.

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