Outcome of patients after market withdrawal of thioridazine: a retrospective analysis in a nationwide cohort

Pharmacoepidemiol Drug Saf. 2012 Nov;21(11):1227-31. doi: 10.1002/pds.3346. Epub 2012 Sep 2.

Abstract

Objective: Thioridazine is a first-generation antipsychotic drug that was withdrawn from the market worldwide in 2005. The outcome of clinically stable schizophrenia patients who used thioridazine before market withdrawal was evaluated.

Methods: Nationwide registers in Finland were utilized to study thioridazine use, hospitalization rate and length of hospital stay.

Results: Although thioridazine use continued to diminish year after year, the hospitalization rate remained constant until the withdrawal year of 2005, when the percentage of patients hospitalized for schizophrenia doubled.

Conclusion: The market withdrawal of thioridazine predisposed many stable patients towards psychotic relapses. In order to minimize this kind of risk, an overall risk-benefit assessment and a clear-cut plan for the replacement of an antipsychotic should be established before market withdrawal.

MeSH terms

  • Adverse Drug Reaction Reporting Systems*
  • Antipsychotic Agents / administration & dosage
  • Antipsychotic Agents / adverse effects*
  • Antipsychotic Agents / therapeutic use
  • Cohort Studies
  • Databases, Factual
  • Drug Utilization Review*
  • Finland
  • Hospitalization / statistics & numerical data
  • Hospitalization / trends
  • Humans
  • Length of Stay
  • Middle Aged
  • Pharmacoepidemiology
  • Product Recalls and Withdrawals*
  • Retrospective Studies
  • Risk Assessment
  • Schizophrenia / drug therapy*
  • Schizophrenia / epidemiology
  • Thioridazine / administration & dosage
  • Thioridazine / adverse effects*
  • Thioridazine / therapeutic use
  • Treatment Outcome

Substances

  • Antipsychotic Agents
  • Thioridazine