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Multimodal Analysis of FDA Drug Safety Communications: Lessons from Zolpidem

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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.

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Acknowledgements

The authors thank Lee Zwanziger, Ph.D. and Amy Ramanadham, Pharm.D., M.S. from the FDA for their scientific support; and Katrina Garry and Rita Noel for their administrative support.

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Authors and Affiliations

  1. Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham Women’s Hospital, Harvard Medical School, 1620 Tremont St., Suite 3030, Boston, MA, 02120, USA

    Aaron S. Kesselheim, Michael S. Sinha, Sebastian Schneeweiss & Jerry Avorn

  2. Center for Bioethics and Humanities, University of Colorado, Denver, CO, USA

    Eric G. Campbell

  3. US Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring, MD, 20993, USA

    Paula Rausch, Brian M. Lappin, Esther H. Zhou & Gerald J. Dal Pan

Authors
  1. Aaron S. Kesselheim
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  2. Michael S. Sinha
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  3. Eric G. Campbell
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  4. Sebastian Schneeweiss
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  5. Paula Rausch
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  6. Brian M. Lappin
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  7. Esther H. Zhou
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  8. Jerry Avorn
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  9. Gerald J. Dal Pan
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Corresponding authors

Correspondence to Aaron S. Kesselheim or Gerald J. Dal Pan.

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Funding

This study was funded by the FDA Center for Drug Evaluation and Research (Contract No. HHSF22301001T). Aaron S. Kesselheim is also supported by Arnold Ventures and the Harvard-MIT Center for Regulatory Science.

Conflict of interest

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 have no conflicts of interest that are directly relevant to the content of this study.

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Kesselheim, A.S., Sinha, M.S., Campbell, E.G. et al. Multimodal Analysis of FDA Drug Safety Communications: Lessons from Zolpidem. Drug Saf 42, 1287–1295 (2019). https://doi.org/10.1007/s40264-019-00849-8

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  • DOI: https://doi.org/10.1007/s40264-019-00849-8

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