Drug Safety

, Volume 38, Issue 6, pp 565–575 | Cite as

Methodological Approaches to Evaluate the Impact of FDA Drug Safety Communications

  • Aaron S. Kesselheim
  • Eric G. Campbell
  • Sebastian Schneeweiss
  • Paula Rausch
  • Brian M. Lappin
  • Esther H. Zhou
  • John D. Seeger
  • John S. Brownstein
  • Steven Woloshin
  • Lisa M. Schwartz
  • Timothy Toomey
  • Gerald J. Dal Pan
  • Jerry Avorn
Study Design



When the US FDA approves a new prescription drug there is still a great deal remaining to be learned about the safe and proper use of that product. When new information addressing these topics emerges post-approval, the FDA may issue a Drug Safety Communication (DSC) to alert patients and physicians. The effectiveness of the communication—how drug safety messaging conveyed in FDA DSCs changes patient or prescriber behavior—may depend on multiple factors, including the way physicians and patients learn about the information, their understanding of the issues conveyed, and their perception of the importance of the information. In 2013, the FDA issued two DSCs addressing critical new warnings related to products containing the sedative/hypnotic zolpidem.


In this article, we describe a core set of research initiatives that can be used to study how zolpidem-related DSCs affected subsequent physician and patient decision making.


These research initiatives include analyzing drug utilization patterns and related health outcomes; comparing zolpidem-containing products against a comparator with similar indications [eszopiclone (Lunesta)] not covered by the 2013 DSCs; and surveying patients and qualitatively evaluating the dissemination of information regarding these drugs in traditional and social-media channels.


Using an integrated, multidisciplinary approach, we can obtain information that can be used to optimize regulatory communications by seeking to understand the impact of the information contained in FDA risk communications.


Zolpidem Risk Communication News Story Eszopiclone Safety Message 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.



The authors would like to thank the following persons: Lee Zwanziger, PhD, Office of Planning, Office of the Commissioner; Amy Ramanadham, PharmD, MS, Office of the Center Director, Center for Drug Evaluation and Research (CDER); and Solomon Iyasu, MD, MPH, Office of Surveillance and Epidemiology (OSE), CDER, for their scientific support. In addition, the authors would also like to thank Katrina Garry, Denise Jones, and Rita Noel, OSE Contracts Management Team, and Larry Russell, MS, OSE Regulatory Support Staff, for their administrative support.

Conflicts of interest

Sebastian Schneeweiss is a consultant to WHISCON LLC, a consulting company specializing in the conduct of drug safety database studies. He is also a consultant to, and owns some equities in, Aetion, Inc., a software company specializing in the analyses of healthcare databases. Paula Rausch, Brian M. Lappin, Esther H. Zhou, and Gerald J. Dal Pan are employed by the FDA, which commissioned this study. John D. Seeger is a consultant to both WHISCON LLC and Optum. John S. Brownstein owns shares in, and is employed as consultant to, Epidemico, Inc., a technology company that develops social-media mining tools for drug safety. Steven Woloshin and Lisa M. Schwartz were paid under a subcontract for work on this project and are co-founders of Informulary, Inc., a company that provides data regarding the benefit, harms, and uncertainties of prescription drugs. Aaron S. Kesselheim, Eric G. Campbell, Timothy Toomey, and Jerry Avorn have no conflicts of interest that are directly relevant to the content of this study.

Compliance with ethical standards

This study was funded by the Center for Drug Evaluation and Research at the FDA (Contract Number HHSF22301001T). Dr. Kesselheim is also supported by a Greenwall Faculty Scholarship in Bioethics.


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Copyright information

© Springer International Publishing Switzerland 2015

Authors and Affiliations

  • Aaron S. Kesselheim
    • 1
  • Eric G. Campbell
    • 2
  • Sebastian Schneeweiss
    • 1
  • Paula Rausch
    • 3
  • Brian M. Lappin
    • 4
  • Esther H. Zhou
    • 5
  • John D. Seeger
    • 1
  • John S. Brownstein
    • 6
  • Steven Woloshin
    • 7
  • Lisa M. Schwartz
    • 7
  • Timothy Toomey
    • 1
  • Gerald J. Dal Pan
    • 8
  • Jerry Avorn
    • 1
  1. 1.Program on Regulation, Therapeutics, and Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of MedicineBrigham and Women’s Hospital and Harvard Medical SchoolBostonUSA
  2. 2.Mongan Institute for Health Policy ResearchMassachusetts General Hospital and Harvard Medical SchoolBostonUSA
  3. 3.Office of Communications, Center for Drug Evaluation and ResearchFood and Drug AdministrationSilver SpringUSA
  4. 4.Office of Planning, Office of the CommissionerFood and Drug AdministrationSilver SpringUSA
  5. 5.Office of Surveillance and Epidemiology, Center for Drug Evaluation and ResearchFood and Drug AdministrationSilver SpringUSA
  6. 6.Children’s Hospital Epidemiology GroupBoston Children’s Hospital and Harvard Medical SchoolBostonUSA
  7. 7.Center for Medicine and the MediaDartmouth Institute for Health Policy and Clinical PracticeLebanonUSA
  8. 8.Office of Surveillance and Epidemiology, Center for Drug Evaluation and ResearchFood and Drug AdministrationSilver SpringUSA

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