The safety profile of Vilazodone: a study on post-marketing surveillance.
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Date
2020
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Abstract
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.
Description
Masters Degree. University of KwaZulu-Natal, Durban.