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.
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 individuals 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.
In this report, we describe the utilization of various medical products during pregnancies ending in live-birth delivery in the Sentinel Distributed Database (SDD). 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 five Sentinel Data Partners on January 12, 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 where the mother is linked to a singleton infant in the Sentinel Common Data Model (SCDM) Mother‐Infant Linkage (MIL) table.
In this report, we examined bevacizumab and other cancer medication use during pregnancy in the Sentinel Distributed Database (SDD). The study period includes data from January 1, 2001 to September 30, 2015. We distributed this request to 14 Sentinel Data Partners on July 21, 2016.
This analysis describes the clinical characteristics of pregnancies with linked live birth deliveries among individuals with evidence of multiple sclerosis (MS) who were exposed to fingolimod, dimethyl fumarate, beta interferons, or received no MS treatment in the first trimester of pregnancy. This analysis also describes the occurrence of cardiac malformations, urinary malformations, other (non-cardiac, non-urinary) malformations, and any congenital malformations. These outcomes were evaluated based on evidence available in the mothers’ or linked infants’ records in the Sentinel Distributed Database (SDD), from the Sentinel Common Data Model Mother-Infant Linkage (MIL) Table. We distributed this request to five Sentinel Data Partners on January 24, 2023. The study period includes data from January 1, 2011 to June 30, 2022.
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.
A companion analysis describes clinical characteristics of pregnancies with live birth deliveries among individuals with evidence of MS who were exposed to fingolimod, dimethyl fumarate, beta interferons, or received no MS treatment in the first trimester of pregnancy. In that analysis, we describe the occurrence of cardiac malformations, urinary malformations, other (non-cardiac, non-urinary) malformations, and any congenital malformations. These outcomes were evaluated based on evidence available in the mothers’ records in the SDD. We did not utilize the MIL table in that analysis.
This analysis describes clinical characteristics of pregnancies with live birth deliveries among individuals who were exposed to fingolimod, dimethyl fumarate, beta interferons, or received no treatment for multiple sclerosis (MS) in the first trimester of pregnancy. In this analysis, we describe the occurrence of cardiac malformations, urinary malformations, other (non-cardiac, non-urinary) malformations, or and any congenital malformations. These outcomes were evaluated based on evidence available in the mothers’ records in the Sentinel Distributed Database (SDD). We did not utilize the Mother-Infant Linkage (MIL) table in this analysis. We distributed this request to 12 Sentinel Data Partners on January 9, 2023. The study period includes data from January 1, 2011 to August 1, 2022.
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.
A companion analysis describes the clinical characteristics of pregnancies with linked live birth deliveries among individuals with evidence of MS who were exposed to fingolimod, dimethyl fumarate, beta interferons, or received no MS treatment in the first trimester of pregnancy. That analysis also describes the occurrence of cardiac malformations, urinary malformations, other (non-cardiac, non-urinary) malformations, and any congenital malformations evaluated based on evidence available in the mothers’ or linked infants’ records in the SDD, from the Sentinel Common Data Model MIL Table.
The US Food and Drug Administration established the Sentinel System to monitor the safety of medical products. A component of this system includes parameterizable analytic tools to identify mother-infant pairs and evaluate infant outcomes to enable the routine monitoring of the utilization and safety of drugs used in pregnancy. We assessed the feasibility of using the data and tools in the Sentinel System by assessing a known association between topiramate use during pregnancy and oral clefts in the infant. We identified mother-infant pairs using the mother-infant linkage table from six Data Partners contributing to the Sentinel Distributed Database from January 1, 2000, to September 30, 2015. We compared mother-infant pairs with first-trimester exposure to topiramate to mother-infant pairs that were topiramate-unexposed or lamotrigine-exposed and used a validated algorithm to identify oral clefts in the infant. We estimated adjusted risk ratios through propensity score stratification.
Traditional surveillance of adverse infant outcomes following maternal medication exposures relies on pregnancy exposure registries, which are often underpowered. We characterize the statistical power of TreeScan™, a data mining tool, to identify potential signals in the setting of perinatal medication exposures and infant outcomes. We used empirical data to inform background incidence of major congenital malformations and other birth conditions. Statistical power was calculated using two probability models compatible with TreeScan, Bernoulli, and Poisson, while varying the sample size, magnitude of the risk increase, and incidence of a specified outcome. We also simulated larger exposure to referent matching ratios when using the Bernoulli model in the setting of fixed N:1 propensity score matching. Finally, we assessed the impact of outcome misclassification on power.