Hepatitis B infection reported with cancer chemotherapy: analyzing the US FDA Adverse Event Reporting System
Abstract We conducted data mining using the US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) database on spontaneously reported adverse events to evaluate the association between anticancer drug therapy and hepatitis B infection. Reports of hepatitis B infection were retr...
Saved in:
| Main Authors: | , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Wiley
2018-06-01
|
| Series: | Cancer Medicine |
| Subjects: | |
| Online Access: | https://doi.org/10.1002/cam4.1429 |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1849710102407282688 |
|---|---|
| author | Akimasa Sanagawa Yuji Hotta Tomoya Kataoka Yasuhiro Maeda Masahiro Kondo Yoshihiro Kawade Yoshihiro Ogawa Ryohei Nishikawa Masahiro Tohkin Kazunori Kimura |
| author_facet | Akimasa Sanagawa Yuji Hotta Tomoya Kataoka Yasuhiro Maeda Masahiro Kondo Yoshihiro Kawade Yoshihiro Ogawa Ryohei Nishikawa Masahiro Tohkin Kazunori Kimura |
| author_sort | Akimasa Sanagawa |
| collection | DOAJ |
| description | Abstract We conducted data mining using the US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) database on spontaneously reported adverse events to evaluate the association between anticancer drug therapy and hepatitis B infection. Reports of hepatitis B infection were retrieved from the FAERS database. The reporting odds ratio (ROR) was used to estimate the association between hepatitis B infection and various anticancer agents and drug combinations. We detected statistically significant risk signals of hepatitis B for 33 of 64 anticancer agents by ROR (26 cytotoxicity drugs and seven molecular‐targeted drugs). We focused on molecular‐targeted drugs and assessed the risk of hepatitis B from specific anticancer drug combinations. The frequency of hepatitis B infection was significantly high for drugs such as rituximab, bortezomib, imatinib, and everolimus. The addition of cyclophosphamide, doxorubicin, and fludarabine to drug combinations additively enhanced the frequency of hepatitis B infection. There were no reports on hepatitis B infection associated with trastuzumab or azacitidine monotherapy. However, trastuzumab‐containing regimens (e.g., combinations with docetaxel or paclitaxel) were correlated with the incidence of hepatitis B infection, similar to azacitidine monotherapy. Our findings suggest that the concomitant use of anticancer drugs, such as trastuzumab, taxane, and azacitidine, may contribute to the risk of hepatitis B infection. The unique signals detected from the public database might provide clues to eliminate the threat of HBV in oncology. |
| format | Article |
| id | doaj-art-db93cafd62364a07a0c13e5ec3db8212 |
| institution | DOAJ |
| issn | 2045-7634 |
| language | English |
| publishDate | 2018-06-01 |
| publisher | Wiley |
| record_format | Article |
| series | Cancer Medicine |
| spelling | doaj-art-db93cafd62364a07a0c13e5ec3db82122025-08-20T03:15:03ZengWileyCancer Medicine2045-76342018-06-01762269227910.1002/cam4.1429Hepatitis B infection reported with cancer chemotherapy: analyzing the US FDA Adverse Event Reporting SystemAkimasa Sanagawa0Yuji Hotta1Tomoya Kataoka2Yasuhiro Maeda3Masahiro Kondo4Yoshihiro Kawade5Yoshihiro Ogawa6Ryohei Nishikawa7Masahiro Tohkin8Kazunori Kimura9Department of Pharmacy Nagoya City University Hospital Nagoya JapanDepartment of Hospital Pharmacy Graduate School of Pharmaceutical Sciences Nagoya City University Nagoya JapanDepartment of Clinical Pharmaceutics Graduate School of Medical Sciences Nagoya City University Nagoya JapanDepartment of Hospital Pharmacy Graduate School of Pharmaceutical Sciences Nagoya City University Nagoya JapanDepartment of Pharmacy Nagoya City University Hospital Nagoya JapanDepartment of Hospital Pharmacy Graduate School of Pharmaceutical Sciences Nagoya City University Nagoya JapanDepartment of Regulatory Science Graduate School of Pharmaceutical Sciences Nagoya City University Nagoya JapanDepartment of Regulatory Science Graduate School of Pharmaceutical Sciences Nagoya City University Nagoya JapanDepartment of Regulatory Science Graduate School of Pharmaceutical Sciences Nagoya City University Nagoya JapanDepartment of Pharmacy Nagoya City University Hospital Nagoya JapanAbstract We conducted data mining using the US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) database on spontaneously reported adverse events to evaluate the association between anticancer drug therapy and hepatitis B infection. Reports of hepatitis B infection were retrieved from the FAERS database. The reporting odds ratio (ROR) was used to estimate the association between hepatitis B infection and various anticancer agents and drug combinations. We detected statistically significant risk signals of hepatitis B for 33 of 64 anticancer agents by ROR (26 cytotoxicity drugs and seven molecular‐targeted drugs). We focused on molecular‐targeted drugs and assessed the risk of hepatitis B from specific anticancer drug combinations. The frequency of hepatitis B infection was significantly high for drugs such as rituximab, bortezomib, imatinib, and everolimus. The addition of cyclophosphamide, doxorubicin, and fludarabine to drug combinations additively enhanced the frequency of hepatitis B infection. There were no reports on hepatitis B infection associated with trastuzumab or azacitidine monotherapy. However, trastuzumab‐containing regimens (e.g., combinations with docetaxel or paclitaxel) were correlated with the incidence of hepatitis B infection, similar to azacitidine monotherapy. Our findings suggest that the concomitant use of anticancer drugs, such as trastuzumab, taxane, and azacitidine, may contribute to the risk of hepatitis B infection. The unique signals detected from the public database might provide clues to eliminate the threat of HBV in oncology.https://doi.org/10.1002/cam4.1429Cancer chemotherapydata miningFDA Adverse Event Reporting Systemhepatitis B virussignal detection |
| spellingShingle | Akimasa Sanagawa Yuji Hotta Tomoya Kataoka Yasuhiro Maeda Masahiro Kondo Yoshihiro Kawade Yoshihiro Ogawa Ryohei Nishikawa Masahiro Tohkin Kazunori Kimura Hepatitis B infection reported with cancer chemotherapy: analyzing the US FDA Adverse Event Reporting System Cancer Medicine Cancer chemotherapy data mining FDA Adverse Event Reporting System hepatitis B virus signal detection |
| title | Hepatitis B infection reported with cancer chemotherapy: analyzing the US FDA Adverse Event Reporting System |
| title_full | Hepatitis B infection reported with cancer chemotherapy: analyzing the US FDA Adverse Event Reporting System |
| title_fullStr | Hepatitis B infection reported with cancer chemotherapy: analyzing the US FDA Adverse Event Reporting System |
| title_full_unstemmed | Hepatitis B infection reported with cancer chemotherapy: analyzing the US FDA Adverse Event Reporting System |
| title_short | Hepatitis B infection reported with cancer chemotherapy: analyzing the US FDA Adverse Event Reporting System |
| title_sort | hepatitis b infection reported with cancer chemotherapy analyzing the us fda adverse event reporting system |
| topic | Cancer chemotherapy data mining FDA Adverse Event Reporting System hepatitis B virus signal detection |
| url | https://doi.org/10.1002/cam4.1429 |
| work_keys_str_mv | AT akimasasanagawa hepatitisbinfectionreportedwithcancerchemotherapyanalyzingtheusfdaadverseeventreportingsystem AT yujihotta hepatitisbinfectionreportedwithcancerchemotherapyanalyzingtheusfdaadverseeventreportingsystem AT tomoyakataoka hepatitisbinfectionreportedwithcancerchemotherapyanalyzingtheusfdaadverseeventreportingsystem AT yasuhiromaeda hepatitisbinfectionreportedwithcancerchemotherapyanalyzingtheusfdaadverseeventreportingsystem AT masahirokondo hepatitisbinfectionreportedwithcancerchemotherapyanalyzingtheusfdaadverseeventreportingsystem AT yoshihirokawade hepatitisbinfectionreportedwithcancerchemotherapyanalyzingtheusfdaadverseeventreportingsystem AT yoshihiroogawa hepatitisbinfectionreportedwithcancerchemotherapyanalyzingtheusfdaadverseeventreportingsystem AT ryoheinishikawa hepatitisbinfectionreportedwithcancerchemotherapyanalyzingtheusfdaadverseeventreportingsystem AT masahirotohkin hepatitisbinfectionreportedwithcancerchemotherapyanalyzingtheusfdaadverseeventreportingsystem AT kazunorikimura hepatitisbinfectionreportedwithcancerchemotherapyanalyzingtheusfdaadverseeventreportingsystem |