(2005; 12 pages)
THIORIDAZINE - Withdrawn due to poor benefit/risk profile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.
News & Updates, 25 January 2005. Available on the Internet at www.druginfozone.nhs.uk