Abstract:
OBJECTIVE To provide reference for rational drug use in clinic by mining and analysis the adverse drug reaction(ADR) signals induced by canagliflozin in post-marketing experience.
METHODS Reporting odd ratio method and multi-item gamma possion shrinke method were used to mine the adverse reaction signals induced by canagliflozin from the U.S. Food & Drug Administration adverse event reporting system, the medication information of signal included in the study was counted and analyzed.
RESULTS Totally 20 961 611 ADR reports from the first quarter of 2013 to the fourth quarter of 2018 were included in the analysis, among which 28 474 were mainly induced by canagliflozin. A total of 231 ADR signals related to canagliflozin were mined in two ways, with 16 surgical and medical procedure ADR signals. Among the patients with surgical and medical procedure adverse reactions, males were more than females, the patients aged 41-65 years old, daily dose of 100 mg·d
-1 and 300 mg·d
-1 were the most, the number of ADRs were increased along with the long time use of canagliflozin.
CONCLUSION Cangliflozin can lead to the risk of medical procedure such as amputation in patients, it shall be monitored during clinical medication to avoid these serious ADRs.