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.
Cases of congenital syphilis have risen 10-fold in the US between 2012-2022. Lack of screening and adequate treatment for syphilis during pregnancy, often due to a lack of timely prenatal care, are the most cited reasons for transmission to the neonate.
This poster assesses syphilis screening and treatment during pregnancy among publicly and commercially insured pregnant patients in the US. It was presented at the 2024 ISPE Annual Meeting.
There is a significant void in our understanding of the specific medications utilized by pregnant women with COVID-19 in real-world outpatient settings. Existing evidence refers to small populations or inpatient prescriptions only.
This poster estimates medicines use prevalence by pregnancy trimester in non-hospitalized pregnant women with COVID-19 and compare it with pregnant women without COVID-19 and non-pregnant women with COVID-19. It was presented at the 2024 ISPE Annual Meeting.
As part of the FDA User Fee Reauthorization Act of 2022, FDA has been developing the pregnancy safety study framework to address gaps in knowledge about the appropriate use of different study types. The framework can leverage the predicted magnitude of product exposure during pregnancy and study goal (signal identification or evaluation) to help identify the most appropriate study type to assess safety.
This poster estimates the prevalence of key conditions in individuals with child-bearing potential (ICBP) to generate an informed estimation of potential product magnitude of exposure during pregnancy upon approval. It was presented at the 2024 ISPE Annual Meeting.
As part of the FDA User Fee Reauthorization Act of 2022, FDA committed to developing a pregnancy safety study framework to optimize the study types (single-arm descriptive, pregnancy registry, or database studies) to assess medicinal product exposure in pregnancy. The framework will leverage estimated magnitude of exposure
and study goal (signal identification or evaluation) to optimize the study types to assess safety.
This poster characterizes and describes the magnitude of exposure during pregnancies that ended in live births for medicinal products either (1) with an FDA-issued pregnancy safety postmarketing requirement or commitment, (2) listed on the FDA’s Office of Women’s Health Pregnancy Registry webpage, or (3) with a pregnancy observational study in ClinicalTrials.gov. It was presented at the 2024 ISPE Annual Meeting.
In this report, we identified pregnancies ending in live birth delivery in the Sentinel Distributed Database (SDD), and described medical products of interest (MOIs) utilization during pregnancy for select MOIs with pregnancy-related postmarketing requirements, requirement(s) and/or commitment(s), those involved in pregnancy registries, or those investigated in clinical trials with respect to their use during pregnancy.
We distributed this request to six Sentinel Data Partners on August 4, 2023. The study period includes data from January 1, 2008 to January 31, 2023.
This report lists of Current Procedural Terminology, Fourth Edition (CPT-4), Current Procedural Terminology, Third Edition (CPT-3), International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM), International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM), and International Classification of Diseases, Tenth Revision, Procedural Coding System (ICD-10-PCS) codes used to define non-cardiac congenital malformations in this request.
For additional information about the algorithm and how it was defined relative to the cohort and exposure(s) of interest in the analysis, refer to the analysis webpage here.
This analysis estimated the association between use of armodafinil or modafinil during the first trimester of pregnancy compared to use of active comparator medical products (amphetamines or methylphenidate) or to an unexposed comparison group and non-cardiac congenital malformations in a cohort of pregnant patients and their matched infants in the Sentinel Distributed Database (SDD). This is a follow up to a previous analysis that assessed the risk of cardiac congenital malformations following armodafinil or modafinil use during the first trimester of pregnancy.
The study period includes data from January 1, 2000 to December 31, 2022. We distributed this request to four Sentinel Data Partners on August 11, 2023.
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.
This report describes the utilization of ibrexafungerp during pregnancy among patients with live-birth deliveries and describes demographic and pregnancy characteristics among all pregnant patients as well as among pregnant patients with ibrexafungerp use during pregnancy.
The study period includes data from June 1, 2021 to November 30, 2022. We distributed this request to six Rapid Sentinel Data Partners on January 4, 2023.
This presentation describes a preliminary analysis of drug utilization during pregnancies that ended in live-birth delivery. The data is being used to inform development of the pregnancy safety study framework and assess the feasibility of using electronic healthcare claims data for pregnancy safety studies. It was presented at the Duke-Margolis Center for Health Policy two-day Public Workshop: Optimizing the Use of Postapproval Pregnancy Safety Studies.
In this report, we describe the utilization of various medical products during pregnancies ending in live-birth delivery where the mother is linked to a singleton infant in the Sentinel Common Data Model (SCDM) Mother‐Infant Linkage (MIL) table. Medical products of interest (MOIs) include those with pregnancy‐related postmarketing requirements (PMRs) and/or postmarketing commitments (PMCs), those involved in pregnancy registries, or those investigated in studies listed in ClinicalTrials.gov that fulfilled the following search criteria elements with respect to their use during pregnancy: 1) Pregnant, Pregnancy, Observational, 2) Limited to studies associated with a drug or biologic.
We distributed this request to four Sentinel Data Partners on March 24, 2023. The study period includes data from January 1, 2008 to June 30, 2022.
A companion analysis describes utilization of various medical products during pregnancies ending in live-birth delivery but does not utilize the Mother‐Infant Linkage (MIL) table.