Exploiting heterogeneous publicly available data sources for drug safety surveillance: computational framework and case studies

Expert Opin Drug Saf. 2017 Feb;16(2):113-124. doi: 10.1080/14740338.2017.1257604. Epub 2016 Dec 1.


Objective: Driven by the need of pharmacovigilance centres and companies to routinely collect and review all available data about adverse drug reactions (ADRs) and adverse events of interest, we introduce and validate a computational framework exploiting dominant as well as emerging publicly available data sources for drug safety surveillance.

Methods: Our approach relies on appropriate query formulation for data acquisition and subsequent filtering, transformation and joint visualization of the obtained data. We acquired data from the FDA Adverse Event Reporting System (FAERS), PubMed and Twitter. In order to assess the validity and the robustness of the approach, we elaborated on two important case studies, namely, clozapine-induced cardiomyopathy/myocarditis versus haloperidol-induced cardiomyopathy/myocarditis, and apixaban-induced cerebral hemorrhage.

Results: The analysis of the obtained data provided interesting insights (identification of potential patient and health-care professional experiences regarding ADRs in Twitter, information/arguments against an ADR existence across all sources), while illustrating the benefits (complementing data from multiple sources to strengthen/confirm evidence) and the underlying challenges (selecting search terms, data presentation) of exploiting heterogeneous information sources, thereby advocating the need for the proposed framework.

Conclusions: This work contributes in establishing a continuous learning system for drug safety surveillance by exploiting heterogeneous publicly available data sources via appropriate support tools.

Keywords: Adverse drug events; bibliographic databases; case studies; computational framework; emerging data sources for pharmacovigilance; heterogeneous public data; joint exploitation; social media; spontaneous reporting systems.

Publication types

  • Validation Study

MeSH terms

  • Adverse Drug Reaction Reporting Systems*
  • Antipsychotic Agents / adverse effects
  • Cardiotoxicity / etiology
  • Cerebral Hemorrhage / chemically induced
  • Clozapine / adverse effects
  • Drug-Related Side Effects and Adverse Reactions / epidemiology*
  • Factor Xa Inhibitors / adverse effects
  • Haloperidol / adverse effects
  • Humans
  • Information Storage and Retrieval*
  • Pharmacovigilance*
  • Pyrazoles / adverse effects
  • Pyridones / adverse effects


  • Antipsychotic Agents
  • Factor Xa Inhibitors
  • Pyrazoles
  • Pyridones
  • apixaban
  • Clozapine
  • Haloperidol