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Drug Saf. 2019 Nov;42(11):1287-1295. doi: 10.1007/s40264-019-00849-8.

Multimodal Analysis of FDA Drug Safety Communications: Lessons from Zolpidem.

Author information

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. akesselheim@bwh.harvard.edu.
2
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.
3
Center for Bioethics and Humanities, University of Colorado, Denver, CO, USA.
4
US Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring, MD, 20993, USA.
5
US Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring, MD, 20993, USA. Gerald.DalPan@fda.hhs.gov.

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.

PMID:
31302895
DOI:
10.1007/s40264-019-00849-8

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