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Schizophrenia drug withdawal
[Posted: Fri 28/01/2005 www.irishhealth.com]
By Niall Hunter
Melleril (thioridazine), an antipsychotic drug for treating schizophrenia , is being voluntarily withdrawn from the market following safety concerns.
The drug, which first became available 45 years ago and was one of the first of the antipsychotic therapies for schizophrenia, is to be withdrawn in Ireland and worldwide by June 30 this year.
The manufacturers Novartis, have announced that the decision to withdraw Melleril is based on available safety data relating to cardiac problems and risk of sudden death during treatment.
The company said that since the benefit/risk profile of Melleril is no longer considered to meet current clinical and regulatory expectations and the availability of new antipsychotic treatments has changed the comparative benefit-risk profile of older antipsychotic drugs such as Melleril, it has been decided to withdraw voluntarily it worldwide by June 30.
Doctors have been provided with recommendations by the manufacturers on safe discontinuation and possible switch to alternative medications for patients currently taking Melleril.
Four years ago, the Irish Medicines Board moved to restrict the recommended use of Melleril and to increase existing warning statements regarding the risk of cardiac problems with the drug.
It restricted the use of thioridazine to second-line treatment in adult schizophrenia only under the supervision of a consultant psychiatrist. It banned its use in children, for which it had been used for severe mental/behaviour problems, and for the treatment of anxiety disorders including those associated with agitation and senile confusion.
The IMB stated at the time (2001) that the manufacturer intended to discontinue the availability of Melleril.
The IMB told irishhealth.com that the product had in recent years been continually monitored by the European Medicines Agency, to which the IMB is affiliated.
It said the manufacturers had been in discussion with the IMB about Melleril and it had been agreed that there would be a phased withdrawal in order to allow doctors to change patients over to alternative treatments.
Generic versions of the drug are also to be disconoinued.
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