Drug-induced hepatitis B virus reactivation: insights from FAERS database analysis.

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.