Study on safety risk signals of molnupiravir based on FAERS data
AIM To mine the risk signals of adverse events related to the new antiviral drug molnupiravir based on post-marketing pharmacovigilance data,and to provide reference for drug safety.METHODS The reports of adverse drug events(ADE)related to molnupiravir in the FDA Adverse Event Reporting System(FAERS)from Q1 to Q3 2022 were collected and further analyzed by the system organ classification(SOC)and preferred term(PT)of the International Medical Terminology Dictionary(MedDRA).The reporting odds ratio(ROR)method and the British Medicines and Healthcare Products Regulatory Agency's comprehensive standard method were then used to explore the safety risk signals of molnupiravir.RESULTS A total of 1 968 reports with molnupiravir as a suspected drug were screened from the FAERS database,of which 1 743 reports contained adverse events.The age of the report subjects was mainly distributed in individuals aged ≥ 60 years old(58.29％),and most of the reporters were medical professionals(82.62％).A total of 66 positive risk signals at the PT level were identified,involving 17 SOCs.The top 6 PTs in the reports were all known in the instruction of molnupiravir,including diarrhea,rash,nausea,vomiting,dizziness,and urticaria.Signals such as bullous dermatitis in skin and subcutaneous tissue diseases,bleeding in gastrointestinal diseases,and syncope and loss of consciousness in various neurological diseases,were not indicated in the instruction of molnupiravir,and their correlation with molnupiravir cannot be completely ruled out by current evidence.No concerned risk signals,such as mutagenicity and affecting cartilage and bone growth were discovered.CONCLUSION Molnupiravir is relatively safe,and most of the top-ranking risk signals identified are known adverse reactions or pneumonia related symptoms described in the instructions.It is recommended to pay attention to risks such as bullous dermatitis,gastrointestinal bleeding,syncope,and loss of consciousness when using molnupiravir clinically.
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