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The safety profile of Vilazodone: a study on post-marketing surveillance.

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Vilazodone was approved in 2011 as an antidepressant to treat major depressive disorder. Like other antidepressants, vilazodone has adverse effects associated with the use of the drug. Being a relatively new drug, it is not clear if all adverse effects have been identified yet. The aim of this study was therefore to review the adverse effects reported to the WHO Programme for International Drug Monitoring (PIDM). This study then went on to explore the psychiatric adverse effects associated with the use of vilazodone and the factors that have been hypothesized as being responsible for these effects. This study aims to provide a critical summation of present findings to add to the knowledge about the safety profile and adverse effects caused by vilazodone. Method Data on adverse effects reported for vilazodone was obtained from the database VigiAccess managed by PIDM. Data was extracted from VigiAccess using Excel® and analysed using descriptive statistics. The data collected was compared to the patient information leaflet (PIL) of Viibryd® and the FDA documents to determine adverse drug reactions reported post marketing. In order to further explore the psychiatric adverse effects associated with vilazodone, a systematic review was conducted. Databases and reference lists for studies published between January 2000 to January 2020 were searched and a systematic review was conducted using the Cochrane Framework. Primary studies were screened for inclusion and a critical appraisal performed. Data was analysed and frequency tables were used to summarise the data followed by a narrative synthesis. Results A total of 9708 adverse events had been recorded on VigiAccess of which 6054 were not recorded on the PIL and the FDA approval document. Most of the reports were received from the Americas and were for adult women aged 45-64 years (24%, n=1059). The highest number of adverse events reported were for psychiatric events (19%; n=1889), followed by gastrointestinal effects (18%; n=1839). Specific psychiatric disorders recorded included anxiety (316), depression (208), hallucination (168) and agitation (142). The systematic review confirmed several psychiatric adverse effects associated with the use of vilazodone. The findings of this study suggested that these common psychiatric adverse effects associated with the use of vilazodone were not known during the time of FDA approval of the drug and is not currently recorded in the patient information leaflet (PIL). Conclusions In summary, this study found several adverse drug reactions not recorded in documents emanating from clinical trials pre-marketing. This highlights the importance of continued postmarketing surveillance of a drug, as well as the need for further studies on the psychiatric adverse events associated with vilazodone in order to improve the safety profile.


Masters Degree. University of KwaZulu-Natal, Durban.