Evaluation of the Safety Profile of Zolafren®, a Generic Olanzapine Formulation, in Patients with Bipolar Disorder: A Post-Authorization Safety Study
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).
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.
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.
The results of this PASS support the safety of Zolafren use and indicate a high tolerance in patients treated for BD.
Adamed Sp. z o.o., Czosnów, Poland.
KeywordsAdverse reactions Bipolar disorder Olanzapine generic Psychiatry Safety Tolerability Zolafren
This study and the associated article processing charges study were funded by the pharmaceutical company Adamed Sp. z o.o (Grant No AMD/ZOL/2011/013). The study was organized by Europharma Rachtan Co. Ltd., which provided assistance in the field of medical services (http://www.europharma.edu.pl/eng/). Europharma Rachtan Co. Ltd. designed the study and are the copyright holders. The authors thank Mike Smertka, MD, Ph.D. for his invaluable editorial help during the preparation of this manuscript. All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this manuscript, take responsibility for the integrity of the work as a whole, and have given final approval for the version to be published.
Conflict of interest
Jerzy Chudek received honorarium for the manuscript preparation. Magdalena Olszanecka-Glinianowicz received honorarium for design of the study. Agnieszka Almgren-Rachtan is employed by Europharma Rachtan Co. Ltd. (Director of the Department of Pharmacovigilance). Tomasz Gabryelewicz declares no conflict of interest.
Compliance with ethics guidelines
According to the Polish law, post-authorization safety studies are not medical experiments and do not require either Bioethical Committee approval or the need to obtain informed consent from the patients for inclusion. As such, this study did not require ethical approval and it was not necessary to obtain informed consent from patients for inclusion in this study.
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