Enrollment and Retention in 34 United States Pregnancy Registries Contrasted with the Manufacturer’s Capture of Spontaneous Reports for Exposed Pregnancies

Steven T. Bird (), Kate Gelperin, Lockwood Taylor, Leyla Sahin, Hoda Hammad, Susan E. Andrade, Mohamed A. Mohamoud, Sengwee Toh and Christian Hampp
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Steven T. Bird: Center for Drug Evaluation and Research, Food and Drug Administration
Kate Gelperin: Center for Drug Evaluation and Research, Food and Drug Administration
Lockwood Taylor: Center for Drug Evaluation and Research, Food and Drug Administration
Leyla Sahin: Center for Drug Evaluation and Research, Food and Drug Administration
Hoda Hammad: Division of Biostatistics and Epidemiology
Susan E. Andrade: University of Massachusetts Medical School
Mohamed A. Mohamoud: Center for Drug Evaluation and Research, Food and Drug Administration
Sengwee Toh: Harvard Medical School and Harvard Pilgrim Health Care Institute
Christian Hampp: Center for Drug Evaluation and Research, Food and Drug Administration

Drug Safety, 2018, vol. 41, issue 1, No 6, 87-94

Abstract: Abstract Introduction Pregnancy registries and spontaneous reports are essential pharmacovigilance tools to evaluate drug safety during pregnancy. Objectives The aim of this study was to evaluate postmarket capture of exposed pregnancies. Methods Pregnancy registries for drugs and biologics were identified in a systematic review. Through a standardized questionnaire, manufacturers provided information on (1) pregnancy registry enrollment and retention, and (2) worldwide receipt of spontaneous reports for exposed pregnancies. A validated algorithm for live-birth pregnancies allowed calculation of exposure rates per 100,000 live births using claims data. Results Among 34 products with a pregnancy registry, median (interquartile range) registry enrollment was 36 pregnancies (5–258) and median spontaneous report capture was 450 pregnancies (89–1192). Products used in >20/100,000 live births had a median registry enrollment of 490 pregnancies and median capture of 1061 spontaneously reported exposed pregnancies. Lower median registry enrollment and spontaneous report capture was observed for products used in 0.5–20/100,000 live births (36 from registries, 541 spontaneous reports) and

Date: 2018
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DOI: 10.1007/s40264-017-0591-5

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