PMID- 36881059
OWN - NLM
STAT- MEDLINE
DCOM- 20230309
LR  - 20230322
IS  - 1791-7549 (Electronic)
IS  - 0258-851X (Print)
IS  - 0258-851X (Linking)
VI  - 37
IP  - 2
DP  - 2023 Mar-Apr
TI  - Assessment of Time-to-onset and Outcome of Lung Adverse Events With Pomalidomide 
      from a Pharmacovigilance Study.
PG  - 955-961
LID - 10.21873/invivo.13168 [doi]
AB  - BACKGROUND/AIM: Pomalidomide is an immunomodulatory drug that is used to treat 
      multiple myeloma. We examined the time-to-onset and outcome of lung adverse 
      events (LAEs) related to pomalidomide in Japanese patients based on information 
      obtained from the spontaneous reporting system of the Japanese Adverse Drug Event 
      Report database (JADER) of the Pharmaceuticals and Medical Devices Agency. 
      PATIENTS AND METHODS: We analyzed adverse events (AEs) reports recorded between 
      April 2004 and March 2021 from JADER. Data on LAEs were extracted, and the 
      relative risk of AEs was estimated using the reporting odds ratio and 95% 
      confidence interval. We analyzed 1,772,494 reports and identified 2,918 reports 
      of AEs caused by pomalidomide. Of these, 253 LAEs were reportedly associated with 
      pomalidomide. RESULTS: Signals were detected for five LAEs: pneumonia, 
      pneumocystis jirovecii pneumonia, bronchitis, pneumonia bacterial, and pneumonia 
      pneumococcal. Pneumonia was the most frequently mentioned condition (68.8%). The 
      median time-to-onset of pneumonia was 66 days, but some cases of pneumonia 
      occurred as late as 20 months after the start of administration. Fatal outcomes 
      were observed in two of the five AEs wherein signals were detected and were due 
      to pneumonia and bacterial pneumonia. CONCLUSION: Serious outcomes can occur 
      after pomalidomide administration. It has been suggested that these LAEs occur 
      relatively early after pomalidomide administration. Since some situations can 
      result in fatal consequences, patients should be monitored for the emergence of 
      these AEs over a prolonged period of time, especially for pneumonia.
CI  - Copyright (c) 2023, International Institute of Anticancer Research (Dr. George J. 
      Delinasios), All rights reserved.
FAU - Kawahara, Yuka
AU  - Kawahara Y
AD  - Department of Education and Research Center for Pharmacy Practice, Faculty of 
      Pharmaceutical Sciences, Doshisha Women's College of Liberal Arts, Kyotanabe, 
      Japan.
FAU - Murata, Saeko
AU  - Murata S
AD  - Department of Education and Research Center for Pharmacy Practice, Faculty of 
      Pharmaceutical Sciences, Doshisha Women's College of Liberal Arts, Kyotanabe, 
      Japan.
FAU - Shimizu, Tadashi
AU  - Shimizu T
AD  - School of Pharmacy, Hyogo University of Health Sciences, Kobe, Japan.
FAU - Uesawa, Yoshihiro
AU  - Uesawa Y
AD  - Department of Medical Molecular Informatics, Meiji Pharmaceutical University, 
      Tokyo, Japan.
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, Kyotanabe, 
      Japan; m-uchida@dwc.doshisha.ac.jp.
LA  - eng
PT  - Journal Article
PL  - Greece
TA  - In Vivo
JT  - In vivo (Athens, Greece)
JID - 8806809
RN  - D2UX06XLB5 (pomalidomide)
RN  - 4Z8R6ORS6L (Thalidomide)
SB  - IM
MH  - Humans
MH  - Pharmacovigilance
MH  - Thalidomide/adverse effects
MH  - *Multiple Myeloma
MH  - *Drug-Related Side Effects and Adverse Reactions/diagnosis/epidemiology/etiology
MH  - Lung
PMC - PMC10026632
OTO - NOTNLM
OT  - Japanese Adverse Drug Event Report database (JADER)
OT  - Pomalidomide
OT  - lung adverse events
COIS- The Authors have no relevant financial or non-financial interests to disclose in 
      relation to this study.
EDAT- 2023/03/08 06:00
MHDA- 2023/03/10 06:00
PMCR- 2023/03/03
CRDT- 2023/03/07 11:03
PHST- 2022/12/26 00:00 [received]
PHST- 2023/02/05 00:00 [revised]
PHST- 2023/02/07 00:00 [accepted]
PHST- 2023/03/08 06:00 [pubmed]
PHST- 2023/03/10 06:00 [medline]
PHST- 2023/03/07 11:03 [entrez]
PHST- 2023/03/03 00:00 [pmc-release]
AID - 37/2/955 [pii]
AID - 10.21873/invivo.13168 [doi]
PST - ppublish
SO  - In Vivo. 2023 Mar-Apr;37(2):955-961. doi: 10.21873/invivo.13168.