PMID- 36114412 OWN - NLM STAT- MEDLINE DCOM- 20220920 LR - 20221116 IS - 2045-2322 (Electronic) IS - 2045-2322 (Linking) VI - 12 IP - 1 DP - 2022 Sep 16 TI - Evaluation of lung toxicity with bevacizumab using the spontaneous reporting database. PG - 15619 LID - 10.1038/s41598-022-19887-x [doi] LID - 15619 AB - This study was undertaken to determine the risk of bevacizumab-induced lung toxicity, time to onset, and post hoc outcomes using the Japanese Adverse Drug Event Report database. We analysed data for the period between April 2004 and March 2021. Data on lung toxicities were extracted, and relative risk of adverse events (AEs) was estimated using the reporting odds ratio. We analysed 5,273,115 reports and identified 20,399 reports of AEs caused by bevacizumab. Of these, 1679 lung toxicities were reportedly associated with bevacizumab. Signals were detected for nine lung toxicities. A histogram of times to onset showed occurrence from 35 to 238 days, but some cases occurred even more than one year after the start of administration. Approximately 20% of AEs were thromboembolic events. Among these, pulmonary embolism was the most frequently reported and fatal cases were also reported. The AEs showing the highest fatality rates were pulmonary haemorrhage, pulmonary infarction, and pulmonary thrombosis. In conclusion, we focused on lung toxicities caused by bevacizumab as post-marketing AEs. Some cases could potentially result in serious outcomes, patients should be monitored for signs of onset of AEs not only at the start of administration, but also over a longer period of time. CI - (c) 2022. The Author(s). FAU - Kanbayashi, Yuko AU - Kanbayashi Y AD - Department of Education and Research Center for Clinical Pharmacy, Faculty of Pharmacy, Osaka Medical and Pharmaceutical University, 4-20-1 Nasahara, Takatsuki, Osaka, 569-1094, Japan. yuko.kambayashi@ompu.ac.jp. FAU - Uchida, Mayako AU - Uchida M AD - Department of Education and Research Center for Pharmacy Practice, Faculty of Pharmaceutical Sciences, Doshisha Women's College of Liberal Arts, 97-1, Kodominamihokotate, Kyotanabe-shi, Kyoto, Japan. FAU - Kashiwagi, Misui AU - Kashiwagi M AD - Department of Education and Research Center for Pharmacy Practice, Faculty of Pharmaceutical Sciences, Doshisha Women's College of Liberal Arts, 97-1, Kodominamihokotate, Kyotanabe-shi, Kyoto, Japan. FAU - Akiba, Hitomi AU - Akiba H AD - Department of Education and Research Center for Pharmacy Practice, Faculty of Pharmaceutical Sciences, Doshisha Women's College of Liberal Arts, 97-1, Kodominamihokotate, Kyotanabe-shi, Kyoto, Japan. FAU - Shimizu, Tadashi AU - Shimizu T AD - School of Pharmacy, Hyogo Medical University, 1-3-6 Minatojima, Kobe, Hyogo, Japan. LA - eng PT - Journal Article DEP - 20220916 PL - England TA - Sci Rep JT - Scientific reports JID - 101563288 RN - 2S9ZZM9Q9V (Bevacizumab) SB - IM MH - *Adverse Drug Reaction Reporting Systems MH - Bevacizumab/adverse effects MH - Databases, Factual MH - *Drug-Related Side Effects and Adverse Reactions/epidemiology MH - Humans MH - Lung PMC - PMC9481601 COIS- The authors declare no competing interests. EDAT- 2022/09/17 06:00 MHDA- 2022/09/21 06:00 PMCR- 2022/09/16 CRDT- 2022/09/16 23:36 PHST- 2022/04/03 00:00 [received] PHST- 2022/09/06 00:00 [accepted] PHST- 2022/09/16 23:36 [entrez] PHST- 2022/09/17 06:00 [pubmed] PHST- 2022/09/21 06:00 [medline] PHST- 2022/09/16 00:00 [pmc-release] AID - 10.1038/s41598-022-19887-x [pii] AID - 19887 [pii] AID - 10.1038/s41598-022-19887-x [doi] PST - epublish SO - Sci Rep. 2022 Sep 16;12(1):15619. doi: 10.1038/s41598-022-19887-x.