PMID- 34982723
OWN - NLM
STAT- MEDLINE
DCOM- 20220429
LR  - 20220429
IS  - 2369-2960 (Electronic)
IS  - 2369-2960 (Linking)
VI  - 8
IP  - 1
DP  - 2022 Jan 4
TI  - Comparison of Online Patient Reviews and National Pharmacovigilance Data for 
      Tramadol-Related Adverse Events: Comparative Observational Study.
PG  - e33311
LID - 10.2196/33311 [doi]
LID - e33311
AB  - BACKGROUND: Tramadol is known to cause fewer adverse events (AEs) than other 
      opioids. However, recent research has raised concerns about various safety 
      issues. OBJECTIVE: We aimed to explore these new AEs related to tramadol using 
      social media and conventional pharmacovigilance data. METHODS: This study used 2 
      data sets, 1 from patients' drug reviews on WebMD (January 2007 to January 2021) 
      and 1 from the US Food and Drug Administration (FDA) Adverse Event Reporting 
      System (FAERS; January 2016 to December 2020). We analyzed 2062 and 29,350 
      patient reports from WebMD and FAERS, respectively. Patient posts on WebMD were 
      manually assigned the preferred terms of the Medical Dictionary for Regulatory 
      Activities. To analyze AEs from FAERS, a disproportionality analysis was 
      performed with 3 measures: proportional reporting ratio, reporting odds ratio, 
      and information component. RESULTS: From the 869 AEs reported, we identified 125 
      new signals related to tramadol use not listed on the drug label that satis fi ed 
      all 3 signal detection criteria. In addition, 20 serious AEs were selected from 
      new signals. Among new serious AEs, vascular disorders had the largest signal 
      detection criteria value. Based on the disproportionality analysis and patients' 
      symptom descriptions, tramadol-induced pain might also be an unexpected AE. 
      CONCLUSIONS: This study detected several novel signals related to tramadol use, 
      suggesting newly identified possible AEs. Additionally, this study indicates that 
      unexpected AEs can be detected using social media analysis alongside traditional 
      pharmacovigilance data.
CI  - (c)Susan Park, So Hyun Choi, Yun-Kyoung Song, Jin-Won Kwon. Originally published in 
      JMIR Public Health and Surveillance (https://publichealth.jmir.org), 04.01.2022.
FAU - Park, Susan
AU  - Park S
AUID- ORCID: 0000-0002-7082-8554
AD  - BK21 FOUR Community-Based Intelligent Novel Drug Discovery Education Unit, 
      College of Pharmacy, Research Institute of Pharmaceutical Sciences, Kyungpook 
      National University, Daegu, Republic of Korea.
FAU - Choi, So Hyun
AU  - Choi SH
AUID- ORCID: 0000-0002-1703-9580
AD  - Department of Statistics, Kyungpook National University, Daegu, Republic of 
      Korea.
FAU - Song, Yun-Kyoung
AU  - Song YK
AUID- ORCID: 0000-0003-3687-4052
AD  - College of Pharmacy, Daegu Catholic University, Gyeongsan-si, Gyeongbuk, Republic 
      of Korea.
FAU - Kwon, Jin-Won
AU  - Kwon JW
AUID- ORCID: 0000-0003-3467-7805
AD  - BK21 FOUR Community-Based Intelligent Novel Drug Discovery Education Unit, 
      College of Pharmacy, Research Institute of Pharmaceutical Sciences, Kyungpook 
      National University, Daegu, Republic of Korea.
LA  - eng
PT  - Journal Article
PT  - Observational Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20220104
PL  - Canada
TA  - JMIR Public Health Surveill
JT  - JMIR public health and surveillance
JID - 101669345
RN  - 39J1LGJ30J (Tramadol)
SB  - IM
MH  - Adverse Drug Reaction Reporting Systems
MH  - *Drug-Related Side Effects and Adverse Reactions/epidemiology
MH  - Humans
MH  - Pharmacovigilance
MH  - *Tramadol/adverse effects
MH  - United States/epidemiology
MH  - United States Food and Drug Administration
PMC - PMC8767477
OTO - NOTNLM
OT  - adverse effect
OT  - drug safety
OT  - pharmacovigilance
OT  - social media
OT  - tramadol
COIS- Conflicts of Interest: None declared.
EDAT- 2022/01/05 06:00
MHDA- 2022/04/30 06:00
PMCR- 2022/01/04
CRDT- 2022/01/04 17:15
PHST- 2021/09/01 00:00 [received]
PHST- 2021/11/27 00:00 [accepted]
PHST- 2021/11/08 00:00 [revised]
PHST- 2022/01/04 17:15 [entrez]
PHST- 2022/01/05 06:00 [pubmed]
PHST- 2022/04/30 06:00 [medline]
PHST- 2022/01/04 00:00 [pmc-release]
AID - v8i1e33311 [pii]
AID - 10.2196/33311 [doi]
PST - epublish
SO  - JMIR Public Health Surveill. 2022 Jan 4;8(1):e33311. doi: 10.2196/33311.