Developing and refining methods to assess medical product utilization, safety, and effectiveness during pregnancy is a focus of FDA’s Sentinel System. The Sentinel Common Data Model (SCDM) includes a Mother-Infant Linkage (MIL) table that enables routine evaluation of the effects of medical product exposures during pregnancy on infant outcomes. Descriptions of efforts led by the Center for Drug Evaluation and Research are shown below. Please visit the links to learn more about each area of activity.
In this request we replicated the Hernandez-Diaz, et al. (1) study assessing risk of oral clefts with topiramate use during the first trimester of pregnancy. The replication was conducted to assess the performance of a newly developed inferential pregnancy tool for use in the Sentinel Distributed Database (SDD). The study period included data from January 1, 2000 to September 30, 2015. We distributed this request to six Sentinel Data Partners on June 19, 2020. These six Data Partners are a subset of the SDD and only include those that populate the Mother-Infant Linkage Table.
Report 1 does not require any duration of medical or drug coverage for mothers and infants after delivery.
Report 2 requires that mothers and infants have 90 days of medical and drug coverage after delivery.
The analytic package associated with this analysis can be found externally in Sentinel's Git Repository located here. The Git Repository serves as Sentinel's version control tracking system for analytic packages and technical documentation.
(1) Hernández-Díaz, S., et al. Topiramate use early in pregnancy and the risk of oral clefts: A pregnancy cohort study. Neurology. 2018; 90(4):e342-e351.
This analysis characterized the frequency of IV iron utilization by week relative to live birth and stillbirth deliveries. Information from this analysis contributed to a class-wide labeling update for parenteral iron products to add new safety information to the Use in Specific Populations, Pregnancy section of the label. This update describes the risk of severe adverse reactions to pregnant women and their fetus.
Dolutegravir (DTG) is an integrase strand transfer inhibitor indicated for the treatment of human immunodeficiency virus (HIV) type-1 infection. This study aims to describe the prevalence of exposure to DTG-containing regimens among women of child-bearing age living with HIV and among pregnant women in the Sentinel System. Using the Sentinel Distributed Database (SDD), the prevalence of DTG use was examined (using National Drug Codes) among women of childbearing age (15 to 49 years old) with an HIV diagnosis and among women aged 15 to 49 years old with live birth deliveries from August 2013 through March 2018.
The following presentation was presented at the 35th International Conference on Pharmacoepidemiology and Therapeutic Risk Management in 2019.
The purpose of this report was to compare the frequency of diagnoses for diabetes mellitus with pregnancy using International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) versus International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) codes. ICD-10-CM code definitions were determined by mapping from ICD-9-CM code definitions using the Centers for Medicare and Medicaid Services (CMS) General Equivalence Mappings (GEMs). Simple forward mapping (SFM) and forward-backward mapping (FBM) were used to map ICD-9-CM to ICD-10-CM codes. (1)
(1) Fung, K. W., et al. (2016). "Preparing for the ICD-10-CM Transition: Automated Methods for Translating ICD Codes in Clinical Phenotype Definitions." EGEMS (Wash DC) 4(1): 1211.