Abstract:
OBJECTIVE To analyze and compare the adverse event information of bisphosphonate(BPS) based on the FDA adverse event reporting system(FAERS) database, and to explore potential adverse drug reaction(ADR) signals, in order to optimize the treatment plan for patients and provide a basis for clinical safe and rational drug use.
METHODS Adverse event reports were extracted from FAERS from the first quarter of 2004 to the fourth quarter of 2020, and the BPS reports were mined using report odds ratio(ROR) method and proportional report report ratio(PRR) method. After obtaining effective signals, the Medical Dictionary for Regulatory Activities(MedDRA) term set was used for Chinese system and organ classification.
RESULTS After screening, the results showed that alendronate sodium involved 19 systems, a total of 1 072 signals. Zoledronic acid involved 20 systems with 709 kinds of signals. Risedronic acid involved 20 systems with a total of 638 signals. Pamidronic acid involved 18 systems with a total of 456 signals. Ibandronic acid involved 19 systems with a total of 361 signals.
CONCLUSION In this study, ROR and PRR methods are effectively used to mine ADR signals of 5 BPS. There are certain differences in ADR among the 5 BPS, which can provide certain reference for clinical drug use and promote rational clinical drug use.