Analytical Study of Adverse Events of Alirocumab Based on FAERS

OBJECTIVE To explore the potential adverse event of alirocumab by digging the warning signals of this drug in FDA adverse event reporting system(FAERS) and to provide a basis for clinical safe medication. METHODS The FAERS database was searched for adverse events on alirocumab, the search time limit is from the 3rd quarter of 2015 to the 4th quarter of 2019, a total of 18 quarters, the reporting odds ratio and proportional reporting ratio were used to detect at the same time to obtain the warning signs of the drug. RESULTS After multiple screening, the signals obtained by the ROR and the PRR completely overlapped a total of 41 signals and which 28 adverse events were not appear in the specification. The strong signal of alirocumab mainly concentrated in myalgia, muscle spasm, influenza, injection site reaction, etc. The system organ classification involved the most signals mainly in musculoskeletal and connective tissue disorders, nervous system disorders, and infections, etc. At the same time, it was also discovered that the drug may cause nerve perception dysfunction and increased blood glucose and other warning signs. Through further analysis of the adverse events related to gender and age differences, there were 11 high risk signals with gender differences. Male patients should be alert to increased blood creatine phosphokinase, muscle weakness, etc; female patients should be alert to urinary tract infections, injection site reactions, etc. There were 16 high risk signals with age differences. Non-elderly patients should be alert to increased blood creatine phosphokinase, increased hepatic enzyme, etc; elderly patients should be alert to dysphonia gait disturbance, etc. CONCLUSION The use of FAERS for warning signals mining can comprehensively and deeply analyze the adverse events after the listing of alirocumab, and then effectively reduce the risk of clinical medication.