Multimodal Analysis of FDA Drug Safety Communications: Lessons from Zolpidem

Aaron S. Kesselheim (), Michael S. Sinha, Eric G. Campbell, Sebastian Schneeweiss, Paula Rausch, Brian M. Lappin, Esther H. Zhou, Jerry Avorn and Gerald J. Dal Pan ()
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Aaron S. Kesselheim: Brigham Women’s Hospital, Harvard Medical School
Michael S. Sinha: Brigham Women’s Hospital, Harvard Medical School
Eric G. Campbell: University of Colorado
Sebastian Schneeweiss: Brigham Women’s Hospital, Harvard Medical School
Paula Rausch: US Food and Drug Administration
Brian M. Lappin: US Food and Drug Administration
Esther H. Zhou: US Food and Drug Administration
Jerry Avorn: Brigham Women’s Hospital, Harvard Medical School
Gerald J. Dal Pan: US Food and Drug Administration

Drug Safety, 2019, vol. 42, issue 11, No 1, 1287-1295

Abstract: Abstract Because clinical trials conducted for US Food and Drug Administration (FDA) approval occur in carefully monitored settings and often have strict inclusion criteria for participation, new information about drug safety is commonly discovered once a medication is FDA approved and used by larger numbers of patients. The FDA issues Drug Safety Communications when new information arises about the safety of marketed drugs that may change decision making by healthcare providers and patients. Since their inception, over 250 Drug Safety Communications have been issued alerting consumers and prescribers in the USA about safety risks related to prescription and over-the-counter medications. Researchers at the Brigham and Women’s Hospital in Boston in conjunction with officials from the FDA undertook a multi-modal study of the content, dissemination, and uptake of FDA messaging, focusing on two 2013 Drug Safety Communications related to zolpidem (Ambien; Sanofi, Paris, France). Traditional and social media analyses note incomplete dissemination of key DSC messages. Surveys of patients and interviews of physicians and patients suggest important limitations in patient-provider communication that have hindered sharing of safety information with patients. Finally, pharmacoepidemiologic analyses of zolpidem dispensing patterns after the Drug Safety Communications were released suggest possible opportunities for enhancing uptake of new safety knowledge that may lead to changes in clinical practice, where appropriate.

Date: 2019
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DOI: 10.1007/s40264-019-00849-8

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