Citation

Subeesh V, Singh H, Maheswari E, Beulah T. Minerva Psichiatr. 2018; 59(2): 105-110.

Copyright

(Copyright © 2018, Italian Society of Social Psychiatry, Publisher Edizioni Minerva Medica)

DOI

10.23736/S0391-1772.18.01959-3

PMID

unavailable

Abstract

BACKGROUND: Signal detection is a modern technique used for the detection of new (desired or undesired) reaction of a drug. In this study, we made an attempt to address novel adverse drug reactions (ADRs) of blonanserin using disproportionality analysis in the Food and Drug Administration (FDA) Adverse Event Reporting System (AERS) database.

METHODS: A retrospective analysis was carried out in the AERS 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 the second quarter (Q2) of 2015 to the fourth quarter (Q4) of 2016. ROR-1.96SE >1, PRR≥2, and IC-2SD >0 were considered as a positive signal.

RESULTS: The first drug event combination (DEC) of blonanserin was found in 2012 Q1. A total of 11,365,699 DECs were reported in the AERS. Among these, 239 were associated with blonanserin. On analysis, data mining algorithms yielded positive signal for three novel reactions, namely suicide attempt (ROR=12 [95% CI: 8.69-18.16], PRR=14.02 [95% CI: 10.81-18.19], and IC=4.65 [95% CI: 3.57-5.73]), salivary hypersecretion (ROR=8.21 [95% CI: 5.8-11.5], PRR=7.24 [95% CI: 5.41-9.54], and IC=4.65 [95% CI: 3.57-5.73]), and rhabdomyolysis (ROR=5.4 [95% CI: 1.16-9.2], PRR=4.44 [95% CI: 2.29-9.54], and IC=1.18 [95% CI: 1.18-3.52]), as those were well above the pre-set threshold.

CONCLUSIONS: This quantitative method aided in identification of three 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. © 2018 EDIZIONI MINERVA MEDICA.

Language: en

Keywords

human; suicide attempt; rhabdomyolysis; data base; drug induced disease; drug safety; food and drug administration; hypersalivation; algorithm; drug surveillance program; drug combination; Article; statistical parameters; Adverse drug reaction reporting systems; signal detection; blonanserin; Blonanserin; Drug-related side effects and adverse reactions; information component; odds ratio; proportional reporting ratio