Skip to main content
Log in

The Impact of Litigation-Associated Reports on Signal Identification in the US FDA’s Adverse Event Reporting System

  • Research Letter
  • Published:
Drug Safety Aims and scope Submit manuscript

This is a preview of subscription content, log in via an institution to check access.

Access this article

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Fig. 1

References

  1. Rogers JR, Sarpatwari A, Desai RJ, Bohn JM, Khan NF, Kesselheim AS, et al. Effect of lawyer-submitted reports on signals of disproportional reporting in the food and drug administration’s adverse event reporting system. Drug Saf. 2019;42(1):85–93.

    Article  PubMed  Google Scholar 

  2. US FDA Adverse Event Reporting System (FAERS) Public Dashboard. Available at: https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/ucm070093.htm. Accessed 4 Apr 2019.

  3. DuMouchel W. Bayesian data mining in large frequency tables, with an application to the FDA spontaneous reporting system. Am Stat. 1999;53:177–90.

    Google Scholar 

  4. Harinstein L, Kalra D, Kortepeter CM, Munoz MA, Wu E, Dal Pan GJ. Evaluation of postmarketing reports from industry-sponsored programs in drug safety surveillance. Drug Saf. 2019;42(5):649–55.

    Article  CAS  PubMed  Google Scholar 

  5. Klein K, Scholl JHG, De Bruin ML, van Puijenbroek EP, Leufkens HGM, Stolk P. When more is less: an exploratory study of the precautionary reporting bias and its impact on safety signal detection. Clin Pharmacol Ther. 2018;103(2):296–303.

    Article  PubMed  Google Scholar 

Download references

Author information

Authors and Affiliations

Authors

Corresponding author

Correspondence to Monica A. Muñoz.

Ethics declarations

Conflicts of Interest

Monica A. Muñoz and Gerald J. Dal Pan have no conflicts of interest to declare.

Funding

No funding was used for the preparation of this letter.

Disclaimer

The views expressed are those of the authors and do not necessarily represent the position of, nor imply endorsement from, the US FDA or the US Government.

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Muñoz, M.A., Dal Pan, G.J. The Impact of Litigation-Associated Reports on Signal Identification in the US FDA’s Adverse Event Reporting System. Drug Saf 42, 1199–1201 (2019). https://doi.org/10.1007/s40264-019-00834-1

Download citation

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s40264-019-00834-1

Navigation