Signals reported to Rucaparib: An Updated Comprehensive Disproportionality Analysis Using FDA Adverse Event Reporting System

Ovarian cancer currently ranks as the fourth most common cancer. This cancer is metastatic in nature and making it more challenging to manage. Prostate cancer is the one of the major causes of disease and death among men. Approximately 1.6 million men are diagnosed with prostate cancer. Rucaparib, a poly-ADP ribose polymerase inhibitor has been approved by United States Food and Drug Administration for management of ovarian cancer and prostate cancer. Rucaparib was approved by US Food and Drug Administration in the year 2016 for the treatment of ovarian cancer and 2020 for the treatment of prostate cancer. To assess the potential association between rucaparib and the identified signals, a disproportionality analysis of spontaneous reports is being conducted. Reports were taken from FAERS data base and retrospective case/non case study was conducted. Reporting Odds ratio (ROR), Relative Reporting Ratio (RRR), Chi Squared Value (χ ² ) and Proportional Reporting Ratio (PRR) and Drug Event (DE) were used to perform disproportionality analysis. 144 signals were considered as positive adverse drug reactions using the criteria χ ² >4, PRR >2, ROR >2 and DE ≥ 3. Through disproportionality analysis of the FAERS data, signal was identified between the signals-increased prostate specific antigen, decreased serum magnesium levels, decreased glomerular filtration rates, blood iron decreased and vitamin d decreased and rucaparib. The current investigation indicated that rucaparib may increase the incidence of the identified signals.