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Spontaneous adverse event reporting

Session: Poster Session A

(342) Exploration of Novel Adverse Drug Reactions of Trifluoperazine using FAERS database and Identification of Associated Genes and Proteins

Monday, August 26, 2024
8:00 AM – 6:00 PM CEST
Location: Convention Hall II

    Presenting Author(s)

  • Eswaran Maheswari, BPharm, MPharm, PhD

    Professor
    Department of Pharmacy Practice, Faculty of Pharmacy, M.S. Ramaiah University of Applied Sciences, India

    • Co-Author(s)

  • Shravanth R M, BPharm

    Student
    Department of Pharmacy Practice, Faculty of Pharmacy, M.S.Ramaiah University of Applied Sciences
    Davangere, India

Background: Trifluoperazine is an antipsychotic medication indicated for the treatment of schizophrenia and anxiety. Signal detection helps to unravel the potential adverse drug reactions (ADRs).

Objectives: The study was conducted to identify the novel adverse drug reactions reported for Trifluoperazine.

Methods: The adverse reactions reported in the US FDA Adverse Event Reporting System (FAERS) database for Trifluoperazine, since its approval by USFDA in 2001 were analyzed. The Reporting Odds Ratio (ROR) and Proportional Reporting Ratio (PRR) was obtained from the OpenVigil database. The novel ADRs with PRR≥1 and ROR-1.96SE>1 derived using disproportionality analysis were considered as positive signals. The proteins and the genes derived through literature review and HuGE navigator were analyzed for docking studies using PyRX, PYMOL, BIOVIA Discovery Studio, Swiss PDB Viewer softwares.

Results: Among 2815675 reactions reported in the FAERS database, a total of 553 reactions were related to Trifluoperazine. Open Vigil database showed 9 adverse events reported for Tracheo-Oesophageal Fistula and Trifluoperazine. The PRR was 304.89 (157.787; 589.138) and ROR was 307.687 (158.296; 598.066) which indicates a positive signal. The literature analysis and huge navigator showed SHH protein (3M1N), CHD7 protein (7ZTL) and (NOG) (4AAP) are associated to cause Tracheo-Oesophageal Fistula. Docking scores for the Trifluoperazine with SHH protein (3M1N), CHD7 protein (7ZTL) and N-oxalylglycine (NOG) (4AAP) were found to be -7.5, -8.2 and -6.4 respectively.

Conclusions: The above study results showed that Trifluoperazine can potentially cause Tracheo-Oesophageal Fistula which can be a serious congenital adverse drug reaction. Pharmacogenetic and pharmacoepidemiological studies should be conducted to confirm the association between SHH protein (3M1N), CHD7 protein (7ZTL) and (NOG) (4AAP) with Trifluoperazine. The health care professionals should monitor for the identified novel signal among patients administered with Trifluoperazine during pregnancy.