Repercussions of the withdrawal of thioridazine

Abstract

Introduction. As a consequence of the withdrawal of thioridazine from the market, patients who have been treated with this drug require a new therapeutic approach. We have observed patients who require admission to acute unit due to decompensation resulting from the withdrawal of thioridazine who present a difficult management of therapeutic regime. The clinical characteristics and drug treatment needed to stabilize the patient are described.

Results. The sample obtained in our unit included 15 patients with a mean of 20 years of stability prior to withdrawal of thioridazine. This represents 6% of all the patients treated with thioridazine in 2005 in our health care area. They had a common psychopathological profile: affective pattern in addition to the psychotic symptomatology with predominance of emotional lability and hypomaniac tendency which is difficult to control pharmacologically.

Clinical stabilization was obtained in 27% of patients by means of piperazine phenothiazines in monotherapy. An association with mood stabilizer and/or an atypical antipsychotic in 60% of patients was needed. In 40% we prescribed a mood stabilizer to manage affective instability and 27% responded to electroconvulsive therapy (ECT) treatment, which is indicated as a second option due to resistance to pharmacological treatment and/or presenting a serious condition.

Conclusions. We propose starting treatment with a group of piperazine phenothiazines, evaluating the introducing of mood stabilizers and/or ECT in each case. There have been 33% re-admissions, 40% of which required medium/ long-term stay centers and one of which committed suicide.

We demonstrate a high cost in terms of care, economic resources and of quality of life (autonomy, social skills and cognitive level) in our sample as a result of Meleril® (thioridazine) withdrawal of the market.