アブストラクト | BACKGROUND: Reactivation of the hepatitis B virus (HBV) induced by drugs is a commonly overlooked but clinically significant complication, posing risks of treatment interruptions, hepatitis exacerbation, liver failure, and even mortality. METHODS: Disproportionality analyses were conducted on the Food and Drug Administration Adverse Event Reporting System (FAERS) database data spanning from January 2017 to December 2023 to detect drugs posing a risk of HBV reactivation (HBV-R). HBV-R cases were identified using the Medical Dictionary for Regulatory Activities (MedDRA), and drug generic names were ascertained from the DrugBank database. RESULTS: A total of 2596 adverse event reports (AERs) were found to be related to drug-induced HBV-R.According to the disproportionality analysis, the top five drugs with the highest ROR and PRR were daklinza, vocabria, doxorubicin, sovaldi, and ribavirin. The top 40 drugs causing drug-induced HBV-R can be roughly divided into three categories: anti-tumor drugs, immunosuppressive drugs, and antiviral drugs. Among them, 23 drugs do not explicitly mention the risk of HBV-R in their drug instructions. CONCLUSIONS: It was observed that some pharmaceuticals do not adequately address the risk of HBV-R in their drug documentation. These findings could assist healthcare providers in promptly recognizing drug-induced HBV-R. |
ジャーナル名 | Expert opinion on drug safety |
Pubmed追加日 | 2024/12/4 |
投稿者 | Zhang, Genshan; Yan, Hanpeng; Zhang, Haokun; Zhu, Lin; Fu, Jie |
組織名 | Department of Gastrointestinal Surgery, Tongji Hospital, Tongji Medical College,;Huazhong University of Science and Technology, Wuhan, China.;Department of Gastrointestinal Surgery, Wuhan Hospital of Traditional Chinese and;Western Medicine, Tongji Medical College, Huazhong University of Science and;Technology, Wuhan, China.;School of Public Health and Health Management, Gannan Medical University,;Ganzhou, PR China.;Department of Transfusion Medicine, Wuhan Hospital of Traditional Chinese and;Department of Nursing, Tongji Hospital, Tongji Medical College, Huazhong;University of Science and Technology, Wuhan, China. |
Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/39630586/ |