ORIGINAL ARTICLE   

Minerva Psichiatrica 2017 December;58(4):181-6

DOI: 10.23736/S0391-1772.17.01944-6

Copyright © 2017 EDIZIONI MINERVA MEDICA

language: English

Novel adverse events of brexpiprazole: a disproportionality analysis in USA Food and Drug Administration adverse event reporting system database

Viswam SUBEESH ¹ ✉, Hemendra SINGH ², Eswaran MAHESWARI ¹, Thomas BEULAH ¹

¹ Department of Pharmacy Practice, Faculty of Pharmacy, M.S. Ramaiah University of Applied Sciences, Bengaluru, India; ² Department of Psychiatry, Ramaiah Medical College, Bengaluru, India

BACKGROUND: Signal detection is an advanced technique in pharmacovigilance for the early detection of new, rare reactions (desired or undesired) of a drug which enables healthcare professionals to be vigilant in encountering serious adverse events associated with the drug. Brexpiprazole, the second approved D2 partial agonist was intended for the treatment of schizophrenia and as adjunctive therapy for major depressive disorder (MDD). The study aimed at detecting the novel adverse events associated with brexpiprazole by data mining analysis of the Food and Drug Administration (USFDA) database of Adverse Event Reporting System (AERS) using data mining algorithms.
METHODS: A retrospective analysis was carried out in USFDA Adverse Event Reporting System database by applying the three most commonly used data mining algorithms, namely, Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR) and Information Component (IC) from 2015 second quarter (Q2) to 2016 fourth quarter (Q4). A value of ROR-1.96SE>1, PRR≥2, IC- 2SD>0 were considered as the positive signal.
RESULTS: The USFDA AERS database is comprised of 61,66,215 DECs totally which were reported from 2015 Q2 to 2016Q4. Among which, 3548 DECs were associated with brexpiprazole. On analysis, data mining algorithms exhibited positive signal for five novel reactions viz., agitation, anger, depression, dry mouth and insomnia as those were well above the pre-set threshold.
CONCLUSIONS: This quantitative method aided in identification of five novel adverse events. The result warrants an integration of clinical studies for the validation and quantification of possible risks of the adverse events obtained by signal detection technique.

KEY WORDS: Brexpiprazole - Drug-related side effects and adverse reactions - Adverse drug reaction reporting systems