title: Evaluation of Facebook and Twitter Monitoring to Detect Safety Signals for Medical Products: An Analysis of Recent FDA Safety Alerts.
abstract: The rapid expansion of the Internet and computing power in recent years has opened up the possibility of using social media for pharmacovigilance. While this general concept has been proposed by many, central questions remain as to whether social media can provide earlier warnings for rare and serious events than traditional signal detection from spontaneous report data.
  
  
  
  Our objective was to examine whether specific product-adverse event pairs were reported via social media before being reported to the US FDA Adverse Event Reporting System (FAERS).
  
  
  
  A retrospective analysis of public Facebook and Twitter data was conducted for 10 recent FDA postmarketing safety signals at the drug-event pair level with six negative controls. Social media data corresponding to two years prior to signal detection of each product-event pair were compiled. Automated classifiers were used to identify each 'post with resemblance to an adverse event' (Proto-AE), among English language posts. A custom dictionary was used to translate Internet vernacular into Medical Dictionary for Regulatory Activities (MedDRA®) Preferred Terms. Drug safety physicians conducted a manual review to determine causality using World Health Organization-Uppsala Monitoring Centre (WHO-UMC) assessment criteria. Cases were also compared with those reported in FAERS.
  
  
  
  A total of 935,246 posts were harvested from Facebook and Twitter, from March 2009 through October 2014. The automated classifier identified 98,252 Proto-AEs. Of these, 13 posts were selected for causality assessment of product-event pairs. Clinical assessment revealed that posts had sufficient information to warrant further investigation for two possible product-event associations: dronedarone-vasculitis and Banana Boat Sunscreen--skin burns. No product-event associations were found among the negative controls. In one of the positive cases, the first report occurred in social media prior to signal detection from FAERS, whereas the other case occurred first in FAERS.
  
  
  
  An efficient semi-automated approach to social media monitoring may provide earlier insights into certain adverse events. More work is needed to elaborate additional uses for social media data in pharmacovigilance and to determine how they can be applied by regulatory agencies.
authors.affiliation: Epidemico, Inc., Boston, MA, USA.
authors.forename: Carrie E
authors.initials: CE
authors.lastname: Pierce
authors.affiliation: US Food and Drug Administration, Silver Spring, MD, USA.
authors.forename: Khaled
authors.initials: K
authors.lastname: Bouri
authors.affiliation: US Food and Drug Administration, Silver Spring, MD, USA.
authors.forename: Carol
authors.initials: C
authors.lastname: Pamer
authors.affiliation: US Food and Drug Administration, Silver Spring, MD, USA.
authors.forename: Scott
authors.initials: S
authors.lastname: Proestel
authors.affiliation: Epidemico, Inc., Boston, MA, USA.
authors.forename: Harold W
authors.initials: HW
authors.lastname: Rodriguez
authors.affiliation: Epidemico, Inc., Boston, MA, USA.
authors.forename: Hoa
authors.initials: H
authors.lastname: Van Le
authors.affiliation: Epidemico, Inc., Boston, MA, USA.|Northeastern University College of Computer and Information Science, Boston, MA, USA.
authors.forename: Clark C
authors.initials: CC
authors.lastname: Freifeld
authors.affiliation: Epidemico, Inc., Boston, MA, USA.
authors.forename: John S
authors.initials: JS
authors.lastname: Brownstein
authors.affiliation: US Food and Drug Administration, Silver Spring, MD, USA.
authors.forename: Mark
authors.initials: M
authors.lastname: Walderhaug
authors.affiliation: Uppsala Monitoring Centre, WHO Collaborating Centre for International Drug Monitoring, Uppsala, Sweden.
authors.forename: I Ralph
authors.initials: IR
authors.lastname: Edwards
authors.affiliation: Epidemico, Inc., Boston, MA, USA. nabarun@epidemico.com.
authors.forename: Nabarun
authors.identifier: 0000-0002-4098-605X
authors.initials: N
authors.lastname: Dasgupta
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology*; D006801:Humans; D060735:Pharmacovigilance; D012189:Retrospective Studies; D061108:Social Media; D014481:United States; D014486:United States Food and Drug Administration