PMID- 32179761
OWN - NLM
STAT- MEDLINE
DCOM- 20201208
LR  - 20220603
IS  - 2045-2322 (Electronic)
IS  - 2045-2322 (Linking)
VI  - 10
IP  - 1
DP  - 2020 Mar 16
TI  - Safety Profile of Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors: A 
      Disproportionality Analysis of FDA Adverse Event Reporting System.
PG  - 4803
LID - 10.1038/s41598-020-61571-5 [doi]
LID - 4803
AB  - Adverse event reports submitted to the US Food and Drug Administration (FDA) were 
      analyzed to map the safety profile of epidermal growth factor receptor-tyrosine 
      kinase inhibitors (EGFR-TKIs). We conducted a disproportionality analysis of the 
      adverse events (AEs) of EGFR-TKIs (gefitinib, erlotinib, afatinib, osimertinib) 
      by data mining using the FDA adverse event reporting system (AERS) database, and 
      by calculating the reporting odds ratios (ROR) with 95% confidence intervals. The 
      FDA AERS database contained 27,123 EGFR-TKI-associated AERs within the reporting 
      period from January 1, 2004 to March 31, 2018. Thirty-three preferred terms (PTs) 
      were selected for analysis, and significant RORs were most commonly observed in 
      the skin, nail, gastrointestinal tract, hepatic, eyes, and lungs. Unexpected 
      adverse drug reactions were found in the "intestinal obstruction" and 
      "hypokalaemia" in gefitinib and erlotinib, "hyponatraemia" in gefitinib, 
      erlotinib and afatinib, "alopecia"in erlotinib, "hair growth abnormal" in 
      afatinib, but not in "nausea" and "vomiting" listed on drug labels. The results 
      of this study are consistent with clinical observation, suggesting the usefulness 
      of pharmacovigilance research should be corroborated with the real-world FAERS 
      data.
FAU - Huang, Jing
AU  - Huang J
AD  - Department of Respiratory and Critical Care Medicine, The First Affiliated 
      Hospital of Chongqing Medical University, Chongqing, 400016, China.
FAU - Meng, Long
AU  - Meng L
AD  - Department of Pharmacy, The First Affiliated Hospital of Chongqing Medical 
      University, Chongqing, 400016, China.
FAU - Yang, Bing
AU  - Yang B
AD  - Department of Nursing, Chongqing Medical University, Chongqing, 400016, China.
FAU - Sun, Shusen
AU  - Sun S
AD  - Department of Pharmacy Practice, College of Pharmacy and Health Sciences, Western 
      New England University, 1215 Wilbraham Road, Springfield, MA, 01119, USA.
AD  - Department of Pharmacy, Xiangya Hospital Central South University, Changsha, 
      410008, Hunan, China.
AD  - Institute for Rational and Safe Medication Practices, National Clinical Research 
      Center for Geriatric Disorders, Xiangya Hospital, Central South University, 
      Changsha, 410008, Hunan, China.
FAU - Luo, Zhigang
AU  - Luo Z
AD  - Department of Pharmacy, Shihezi People's Hospital, Shihezi, 832000, China.
FAU - Chen, Hong
AU  - Chen H
AD  - Department of Respiratory and Critical Care Medicine, The First Affiliated 
      Hospital of Chongqing Medical University, Chongqing, 400016, China. 
      hopechen2019@126.com.
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20200316
PL  - England
TA  - Sci Rep
JT  - Scientific reports
JID - 101563288
RN  - 0 (Acrylamides)
RN  - 0 (Aniline Compounds)
RN  - 0 (Protein Kinase Inhibitors)
RN  - 3C06JJ0Z2O (osimertinib)
RN  - 41UD74L59M (Afatinib)
RN  - DA87705X9K (Erlotinib Hydrochloride)
RN  - EC 2.7.10.1 (ErbB Receptors)
RN  - EC 2.7.10.1 (Protein-Tyrosine Kinases)
RN  - S65743JHBS (Gefitinib)
SB  - IM
MH  - Acrylamides/*adverse effects
MH  - *Adverse Drug Reaction Reporting Systems
MH  - Afatinib/*adverse effects
MH  - Aniline Compounds/*adverse effects
MH  - Data Mining
MH  - Databases, Factual
MH  - Drug-Related Side Effects and Adverse Reactions/*etiology
MH  - ErbB Receptors/*antagonists & inhibitors
MH  - Erlotinib Hydrochloride/*adverse effects
MH  - Gefitinib/*adverse effects
MH  - Humans
MH  - *Pharmacovigilance
MH  - Protein Kinase Inhibitors/*adverse effects
MH  - Protein-Tyrosine Kinases/*antagonists & inhibitors
MH  - Safety
MH  - United States
MH  - United States Food and Drug Administration
PMC - PMC7075865
COIS- The authors declare no competing interests.
EDAT- 2020/03/18 06:00
MHDA- 2020/12/15 06:00
PMCR- 2020/03/16
CRDT- 2020/03/18 06:00
PHST- 2019/05/13 00:00 [received]
PHST- 2020/02/27 00:00 [accepted]
PHST- 2020/03/18 06:00 [entrez]
PHST- 2020/03/18 06:00 [pubmed]
PHST- 2020/12/15 06:00 [medline]
PHST- 2020/03/16 00:00 [pmc-release]
AID - 10.1038/s41598-020-61571-5 [pii]
AID - 61571 [pii]
AID - 10.1038/s41598-020-61571-5 [doi]
PST - epublish
SO  - Sci Rep. 2020 Mar 16;10(1):4803. doi: 10.1038/s41598-020-61571-5.