Mining and Evaluation of Real World Safety Signals of the Novel Anti-coronavirus Drug Molnupiravir
OBJECTIVE By mining and evaluating the safety signals of Molnupiravir after its marketing,an an-ti-Covid-19 drug,to obtain the ADE occurrence of Molnupiravir in the real world,and to reevaluate its safety,so as to provide reference for clinical rational drug use.METHODS By means of FDA Adverse Event Reporting System(FAERS database),using the reporting odd ratio method(ROR)mine the drug safety signals of Molnupiravir in FAERS database,calculate and screen the data,and re-evaluate the meaningful risk signals.RESULTS A total of 2118 ADEs reports of Molnupiravir up to 2022 were collected,the ratio of male to female was 0.83∶1,the proportion of patients older than 65 years was the highest(56.47%),most suspected ADEs reports were submitted by health-care professionals;The most commonly reported ADEs signals were COVID-19,diarrhea,nausea,rash,vomiting,and dizziness.CONCLUSION The study based on the FAERS database,showed some new adverse reactions outside the phase Ⅲclinical trial of Molnupiravir,such as dysphagia,black stool,heart failure,loss of consciousness,syncope and other signals.The doctors should be based on individual characteristics of patients and strengthen monitoring,ap-propriate prevention and intervention measures should be taken in time to reduce the occurrence of drug injury events.
万方数据
维普
