PMID- 33952819
OWN - NLM
STAT- MEDLINE
DCOM- 20211122
LR  - 20211122
IS  - 1347-5215 (Electronic)
IS  - 0918-6158 (Linking)
VI  - 44
IP  - 5
DP  - 2021
TI  - Disproportionality Analysis of Safety Signals for a Wide Variety of 
      Opioid-Related Adverse Events in Elderly Patients Using the Japanese Adverse Drug 
      Event Report (JADER) Database.
PG  - 627-634
LID - 10.1248/bpb.b20-00904 [doi]
AB  - Opioids are widely used for the treatment of moderate/severe pain in cancer and 
      noncancer patients. In this study, we searched for safety signals for a wide 
      variety of opioid-related adverse events (AEs) in elderly patients by 
      disproportionality analysis using the Japanese Adverse Drug Event Report (JADER) 
      database. Data from the JADER database from April 2004 to May 2018 were obtained 
      from the Pharmaceuticals and Medical Devices Agency website. Safety signal 
      detection of opioid-related AEs in elderly patients was defined using the 
      relative elderly reporting odds ratio (ROR). Among the analyzed AEs, 
      opioid-induced neurotoxicity (OIN) was assessed based on the time to onset using 
      the Weibull shape parameter. The following safety signals were detected in 
      elderly patients: respiratory depression, somnolence, hallucinations, akathisia 
      and OIN. Fentanyl, tramadol, oxycodone and morphine exhibited a large relative 
      elderly ROR for OIN. The median time to onset of OIN of transdermal fentanyl, 
      oral tramadol, oral oxycodone and oral morphine was 13.5, 6, 9, and 6 d, 
      respectively. These opioids were classified as early failure types using the 
      Weibull distribution. Our results showed that elderly patients who are 
      administered opioids should be closely monitored for AEs, such as respiratory 
      depression, OIN and akathisia.
FAU - Omoto, Takashi
AU  - Omoto T
AD  - Department of Pharmacy, Iwate Medical University Hospital.
FAU - Asaka, Junichi
AU  - Asaka J
AD  - Department of Pharmacy, Iwate Medical University Hospital.
AD  - Department of Clinical Pharmaceutics, School of Pharmacy, Iwate Medical 
      University.
FAU - Sakai, Takamasa
AU  - Sakai T
AD  - Drug Informatics, Faculty of Pharmacy, Meijo University.
FAU - Sato, Fumihiko
AU  - Sato F
AD  - Department of Pharmacy, Iwate Medical University Hospital.
FAU - Goto, Nobuyuki
AU  - Goto N
AD  - Department of Pharmacy, University of Fukui Hospital.
FAU - Kudo, Kenzo
AU  - Kudo K
AD  - Department of Pharmacy, Iwate Medical University Hospital.
AD  - Department of Clinical Pharmaceutics, School of Pharmacy, Iwate Medical 
      University.
LA  - eng
PT  - Journal Article
PL  - Japan
TA  - Biol Pharm Bull
JT  - Biological & pharmaceutical bulletin
JID - 9311984
RN  - 0 (Analgesics, Opioid)
SB  - IM
MH  - Adult
MH  - Adverse Drug Reaction Reporting Systems/*statistics & numerical data
MH  - Age Distribution
MH  - Age Factors
MH  - Aged
MH  - Aged, 80 and over
MH  - Analgesics, Opioid/*adverse effects
MH  - Causality
MH  - Drug-Related Side Effects and Adverse Reactions/*epidemiology/etiology
MH  - Female
MH  - Humans
MH  - Japan/epidemiology
MH  - Male
MH  - Middle Aged
MH  - *Pharmacovigilance
MH  - Young Adult
OTO - NOTNLM
OT  - Japanese Adverse Drug Event Report (JADER) database
OT  - disproportionality analysis
OT  - elderly patient
OT  - opioid
OT  - spontaneous reporting system
EDAT- 2021/05/07 06:00
MHDA- 2021/11/23 06:00
CRDT- 2021/05/06 05:58
PHST- 2021/05/06 05:58 [entrez]
PHST- 2021/05/07 06:00 [pubmed]
PHST- 2021/11/23 06:00 [medline]
AID - 10.1248/bpb.b20-00904 [doi]
PST - ppublish
SO  - Biol Pharm Bull. 2021;44(5):627-634. doi: 10.1248/bpb.b20-00904.