PMID- 27601271
OWN - NLM
STAT- MEDLINE
DCOM- 20170731
LR  - 20210109
IS  - 1099-1557 (Electronic)
IS  - 1053-8569 (Print)
IS  - 1053-8569 (Linking)
VI  - 25
IP  - 12
DP  - 2016 Dec
TI  - Can social media data lead to earlier detection of drug-related adverse events?
PG  - 1425-1433
LID - 10.1002/pds.4090 [doi]
AB  - PURPOSE: To compare the patient characteristics and the inter-temporal reporting 
      patterns of adverse events (AEs) for atorvastatin (Lipitor((R)) ) and sibutramine 
      (Meridia((R)) ) in social media (AskaPatient.com) versus the FDA Adverse Event 
      Reporting System (FAERS). METHODS: We identified clinically important AEs 
      associated with atorvastatin (muscle pain) and sibutramine (cardiovascular AEs), 
      compared their patterns in social media postings versus FAERS and used Granger 
      causality tests to assess whether social media postings were useful in 
      forecasting FAERS reports. RESULTS: We analyzed 998 and 270 social media postings 
      between 2001 and 2014, 69 003 and 7383 FAERS reports between 1997 and 2014 for 
      atorvastatin and sibutramine, respectively. Social media reporters were younger 
      (atorvastatin: 53.9 vs. 64.0 years, p < 0.001; sibutramine: 36.8 vs. 43.8 years, 
      p < 0.001). Social media reviews contained fewer serious AEs (atorvastatin, pain: 
      2.5% vs. 38.2%; sibutramine, cardiovascular issues: 7.9% vs. 63.0%; p < 0.001 for 
      both) and concentrated on fewer types of AEs (proportion comprising the top 20 
      AEs: atorvastatin, 88.7% vs. 55.4%; sibutramine, 86.3% vs. 65.4%) compared with 
      FAERS. While social media sibutramine reviews mentioning cardiac issues helped 
      predict those in FAERS 11 months later (p < 0.001), social media atorvastatin 
      reviews did not help predict FAERS reports. CONCLUSIONS: Social media AE 
      reporters were younger and focused on less-serious and fewer types of AEs than 
      FAERS reporters. The potential for social media to provide earlier indications of 
      AEs compared with FAERS is uncertain. Our findings highlight some of the promises 
      and limitations of online social media versus conventional pharmacovigilance 
      sources and the need for careful interpretation of the results. (c) 2016 The 
      Authors. Pharmacoepidemiology and Drug Safety published by John Wiley & Sons Ltd.
CI  - (c) 2016 The Authors. Pharmacoepidemiology and Drug Safety published by John Wiley 
      & Sons Ltd.
FAU - Duh, Mei Sheng
AU  - Duh MS
AD  - Analysis Group, Inc., Boston, MA, USA.
FAU - Cremieux, Pierre
AU  - Cremieux P
AD  - Analysis Group, Inc., Boston, MA, USA.
FAU - Audenrode, Marc Van
AU  - Audenrode MV
AD  - Groupe d'analyse, Ltee, Montreal, QC, Canada.
FAU - Vekeman, Francis
AU  - Vekeman F
AD  - Groupe d'analyse, Ltee, Montreal, QC, Canada.
FAU - Karner, Paul
AU  - Karner P
AD  - Analysis Group, Inc., Boston, MA, USA.
FAU - Zhang, Haimin
AU  - Zhang H
AD  - Groupe d'analyse, Ltee, Montreal, QC, Canada.
FAU - Greenberg, Paul
AU  - Greenberg P
AD  - Analysis Group, Inc., Boston, MA, USA.
LA  - eng
PT  - Journal Article
DEP - 20160907
PL  - England
TA  - Pharmacoepidemiol Drug Saf
JT  - Pharmacoepidemiology and drug safety
JID - 9208369
RN  - 0 (Cyclobutanes)
RN  - A0JWA85V8F (Atorvastatin)
RN  - WV5EC51866 (sibutramine)
SB  - IM
MH  - Adult
MH  - Adverse Drug Reaction Reporting Systems/*statistics & numerical data
MH  - Aged
MH  - Atorvastatin/*adverse effects
MH  - Cyclobutanes/*adverse effects
MH  - Drug-Related Side Effects and Adverse Reactions/epidemiology
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Pharmacovigilance
MH  - Social Media/*statistics & numerical data
MH  - Time Factors
MH  - United States
MH  - United States Food and Drug Administration
PMC - PMC5157765
OTO - NOTNLM
OT  - Granger causality
OT  - Internet
OT  - adverse event
OT  - pharmacoepidemiology
OT  - pharmacovigilance
OT  - social media
EDAT- 2016/09/08 06:00
MHDA- 2017/08/02 06:00
PMCR- 2016/12/15
CRDT- 2016/09/08 06:00
PHST- 2015/10/22 00:00 [received]
PHST- 2016/07/27 00:00 [revised]
PHST- 2016/08/08 00:00 [accepted]
PHST- 2016/09/08 06:00 [pubmed]
PHST- 2017/08/02 06:00 [medline]
PHST- 2016/09/08 06:00 [entrez]
PHST- 2016/12/15 00:00 [pmc-release]
AID - PDS4090 [pii]
AID - 10.1002/pds.4090 [doi]
PST - ppublish
SO  - Pharmacoepidemiol Drug Saf. 2016 Dec;25(12):1425-1433. doi: 10.1002/pds.4090. 
      Epub 2016 Sep 7.