Pay attention to the safety management of conditional marketing authorization drugs for coronavirus disease 2019
10.3760/cma.j.cn114015-20230109-20230001
- VernacularTitle:重视应急附条件获批治疗新型冠状病毒感染药物的安全管理
- Author:
Ajuan ZENG
1
;
Ying HAN
;
Huiguo DING
Author Information
1. 首都医科大学附属北京佑安医院肝病消化中心，北京 100069
- Publication Type:Journal Article
- Keywords:
COVID-19;
Antiviral agents;
Safety;
Drug interactions;
Nirmatrelvir;
Ritonavir;
Molnupiravir;
Azvudine
- From:
Adverse Drug Reactions Journal
2023;25(1):2-5
- CountryChina
- Language:Chinese
-
Abstract:
At present, 3 drugs specially for coronavirus disease 2019 have conditional marketing authorization (CMA) in China, including molnupiravir, nirmatrelvir/ritonavir, and azvudine. The data of clinical efficacy and safety of these drugs are relatively insufficient. Molnupiravir is not the main inhibitor or inducer of drug metabolizing enzyme or transporter and is less likely to have drug interactions, which may be more beneficial to patients with chronic diseases needing long-term drug treatments. Ritonavir in Paxlovid is a strong inhibitor to the key drug metabolism enzyme---CYP3A4, and may interact with a variety of drugs such as drugs for arrhythmia, diabetes, nervous system diseases, etc., resulting in increased drug safety risks in the treatment of underlying diseases. The reproductive and genetic toxicity recorded in the drug label of azvudine is worrying. Joint efforts of our government, hospital managers, clinicians and pharmacists are necessary to achieve the safety management of the 3 drugs, including improving the relevant CMA management regulations, strengthening the efficacy and safety monitoring of these drugs, conducting real world clinical research, and monitoring the variation and drug resistance of the virus.
