title: Evaluation of the safety profile of Zolafren®, a generic olanzapine formulation, in patients with bipolar disorder: a post-authorization safety study.
abstract: BACKGROUND
  Prior to registration, no clinical trial evaluating safety and tolerability of Zolafren® (Adamed Sp. z o.o., Czosnów, Poland), a generic olanzapine formulation, had been performed. Therefore, the aim of this post-authorization safety study (PASS) was to evaluate the safety and tolerability of Zolafren in patients with bipolar disorder (BD).
  
  
  METHODS
  Adverse events (AEs) associated with the use of Zolafren were recorded in a PASS, in an open-label, non-randomized, multicenter observational study involving 20,698 outpatients with BD.
  
  
  RESULTS
  Zolafren was used in both monotherapy (82.8%) and polytherapy (17.2%) at a mean dose of 12.1±4.2 mg. The most commonly used formulation was coated tablets (70.9%). Orally dissolving tablets (19.7%) and hard capsules (9.4%) were less commonly used. During a period of 171±47 days of exposure to Zolafren, 5883 AEs were reported in 2138 patients (10.3% of the study population). None of the reported AEs were severe. Zolafren-associated AEs were the reason for discontinuation in 43 patients and the reason for dose reduction in a further 762 patients. The most common AE was weight gain (by 1.6±3.3 kg) which was considered unrelated to the dose of Zolafren. During follow-up, the percentage of patients with very good tolerance with Zolafren increased from 44.4% to 59.8%. The percentage of patients who had confidence in Zolafren also increased.
  
  
  CONCLUSIONS
  The results of this PASS support the safety of Zolafren use and indicate a high tolerance in patients treated for BD.
  
  
  BACKGROUND
  Adamed Sp. z o.o., Czosnów, Poland.
authors.affiliation: Pathophysiology Unit, Department of Pathophysiology, Medical Faculty in Katowice, Medical University of Silesia, Katowice, Poland, chj@poczta.fm.
authors.forename: Jerzy
authors.initials: J
authors.lastname: Chudek
authors.forename: Magdalena
authors.initials: M
authors.lastname: Olszanecka-Glinianowicz
authors.forename: Agnieszka
authors.initials: A
authors.lastname: Almgren-Rachtan
authors.forename: Tomasz
authors.initials: T
authors.lastname: Gabryelewicz
mesh_terms: D000328:Adult; D014150:Antipsychotic Agents / Q000008:administration & dosage* / Q000009:adverse effects*; D001569:Benzodiazepines / Q000008:administration & dosage* / Q000009:adverse effects*; D001714:Bipolar Disorder / Q000188:drug therapy* / Q000517:prevention & control; D016568:Drugs, Generic; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D000077152:Olanzapine; D013607:Tablets
chemical_list: D014150:Antipsychotic Agents; D016568:Drugs, Generic; D013607:Tablets; D001569:Benzodiazepines; D000077152:Olanzapine