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Multimodal Analysis of FDA Drug Safety Communications: Lessons from Zolpidem

Author

Listed:
  • 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)

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.

Suggested Citation

  • Aaron S. Kesselheim & Michael S. Sinha & Eric G. Campbell & Sebastian Schneeweiss & Paula Rausch & Brian M. Lappin & Esther H. Zhou & Jerry Avorn & Gerald J. Dal Pan, 2019. "Multimodal Analysis of FDA Drug Safety Communications: Lessons from Zolpidem," Drug Safety, Springer, vol. 42(11), pages 1287-1295, November.
  • Handle: RePEc:spr:drugsa:v:42:y:2019:i:11:d:10.1007_s40264-019-00849-8
    DOI: 10.1007/s40264-019-00849-8
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    References listed on IDEAS

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    1. Lauren McCormack & R. Craig Lefebvre & Carla Bann & Olivia Taylor & Paula Rausch, 2016. "Consumer Understanding, Preferences, and Responses to Different Versions of Drug Safety Messages in the United States: A Randomized Controlled Trial," Drug Safety, Springer, vol. 39(2), pages 171-184, February.
    2. Aaron S. Kesselheim & Sarah A. McGraw & Sara Z. Dejene & Paula Rausch & Gerald J. Dal Pan & Brian M. Lappin & Esther H. Zhou & Jerry Avorn & Eric G. Campbell, 2017. "Patient and Physician Perceptions of Drug Safety Information for Sleep Aids: A Qualitative Study," Drug Safety, Springer, vol. 40(6), pages 531-542, June.
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    Cited by:

    1. Esther Vries & Petra Denig & Sieta T. Vries & Taco B. M. Monster & Jacqueline G. Hugtenburg & Peter G. M. Mol, 2020. "Drug Safety Issues Covered by Lay Media: A Cohort Study of Direct Healthcare Provider Communications Sent between 2001 and 2015 in The Netherlands," Drug Safety, Springer, vol. 43(7), pages 677-690, July.
    2. Rania Mouchantaf & Doris Auth & Yola Moride & June Raine & Soon Young Han & Meredith Y. Smith, 2021. "Risk Management for the 21st Century: Current Status and Future Needs," Drug Safety, Springer, vol. 44(4), pages 409-419, April.

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