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Research Letter
September 3, 2019

Association Between Data Sources and US Food and Drug Administration Drug Safety Communications

Author Affiliations
  • 1Department of Diagnostic Imaging, Sheba Medical Center, Ramat Gan, Israel
  • 2Sackler School of Medicine, Tel-Aviv University, Tel Aviv, Israel
  • 3Statistics Consulting Unit, Rabin Medical Center, Beilinson Campus, Petah Tikva, Israel
  • 4Medicine A, Beilinson Hospital, Rabin Medical Center, Petah Tikva, Israel
  • 5Oncology Department, Hospital de la Santa Creu i Sant Pau, Institut d’Investigació Biomèdica Sant Pau, and Universitat Autònoma de Barcelona, Barcelona, Spain
  • 6Princess Margaret Cancer Centre, Division of Medical Oncology, University of Toronto, Toronto, Ontario, Canada
JAMA Intern Med. Published online September 3, 2019. doi:10.1001/jamainternmed.2019.3066

Drug safety communications (DSCs) are the primary tool for the US Food and Drug Administration (FDA) to communicate important new postmarketing safety information to patients and health care professionals.1 Drug safety communications are issued by the FDA for more than one-quarter of new drug and biologic approvals.2 There are known inconsistencies in issuing DSCs across national regulators.3 Less is known about the information source that typically serves as the basis of the initial safety signals that lead to DSCs, such as spontaneous reports aggregated through the FDA’s Adverse Event Reporting System (FAERS),4 results from randomized clinical trials (RCTs), or observational studies. Our objective was to describe the sources of the initial safety signals that lead to DSCs and examine their associations with drug characteristics and subsequent label changes.

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