WHO Pharmaceuticals Newsletter 2005, No. 01
(2005; 12 pages) View the PDF document
Table of Contents
Close this folderREGULATORY MATTERS
View the documentAMIODARONE - Medication Guide to be dispensed along with medicine
View the documentATOMOXETINE - Labelling to include liver injury warning
View the documentBENZATHINE BENZYL-PENICILLIN/PROCAINEBENZYLPENICILLIN - Label changes highlight appropriate use
View the documentMEFLOQUINE - Patient Information Leaflet to help recognize adverse symptoms
View the documentPARACETAMOL-DEXTROPROP-OXYPHENE - To be withdrawn due to risk of toxicity in overdose
View the documentSMALLPOX VACCINE - Label to highlight reports of myopericarditis
View the documentTHIORIDAZINE - Withdrawn due to poor benefit/risk profile
Open this folder and view contentsSAFETY OF MEDICINES
Open this folder and view contentsDRUGS OF CURRENT INTEREST
Open this folder and view contentsFEATURE
 

THIORIDAZINE - Withdrawn due to poor benefit/risk profile

Worldwide. Novartis has announced that it will discontinue all forms of thioridazine (Melleril™) worldwide by 30 June 2005, because the benefit/risk profile of the drug no longer meets current clinical and regulatory expectations. Specifically:

• There is evidence of a connection between QTc prolongation, a known sideeffect of thioridazine, and cardiac arrhythmias and sudden death in patients with schizophrenia.

• New, improved antipsychotic treatments are now available.


It is recommended that when discontinuing treatment with thioridazine, a gradual reduction in dosage over several weeks is recommended to prevent recurrence of symptoms. There are no evidence-based specific recommendations on initiating treatment with an alternative antipsychotic or other psychotropic medication, and formal practical guidelines for switching antipsychotic medication are also lacking. However, a substantial body of information has been published in peerreviewed journals reviewing the techniques commonly employed in clinical practice and the important factors that should be considered. All generic versions of thioridazine are also to be discontinued.

Reference:

News & Updates, 25 January 2005. Available on the Internet at www.druginfozone.nhs.uk

 

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