https://www.sentinelinitiative.org/news-events/fda-safety-communications-labeling-changes/fda-labeling-change-keppra-updated-include
FDA Labeling Change: KEPPRA Updated to Include Risk of Anaphylaxis and Angioedema
Regulatory Impact
04/24/2017
Regulatory Impact
04/24/2017
https://www.sentinelinitiative.org/news-events/publications-presentations/who-gets-treated-influenza-surveillance-study-us-food-and
Who Gets Treated for Influenza: A Surveillance Study From the US Food and Drug Administration’s Sentinel System
Publications and Presentations
08/05/2021
Publications and Presentations
08/05/2021
https://www.sentinelinitiative.org/news-events/publications-presentations/utilization-post-exposure-prophylaxis-prevent-lyme-disease
Utilization of Post-Exposure Prophylaxis to Prevent Lyme Disease in a Large US Healthcare Database
Publications and Presentations
09/29/2021
Publications and Presentations
09/29/2021
https://www.sentinelinitiative.org/studies/drugs/gimoti-metoclopramide
Gimoti (Metoclopramide) & Duration of Use
Assessments
10/12/2021
Assessments
10/12/2021
https://www.sentinelinitiative.org/news-events/publications-presentations/using-inpatient-electronic-medical-records-study-influenza
Using Inpatient Electronic Medical Records to Study Influenza for Pandemic Preparedness
Publications and Presentations
10/25/2021
Publications and Presentations
10/25/2021
https://www.sentinelinitiative.org/methods-data-tools/methods/augmenting-date-death-cause-death-ascertainment-sentinel
Augmenting Date of Death & Cause of Death Ascertainment in Sentinel
Methods, Data, & Tools
03/16/2022
Methods, Data, & Tools
03/16/2022
https://www.sentinelinitiative.org/studies/drugs/individual-drug-analyses/incidence-and-prevalence-confounding-variables-over-time
Incidence and Prevalence of Confounding Variables Over Time in the Sentinel Distributed Database (SDD): A Descriptive Analysis
Analyses
04/21/2022
Analyses
04/21/2022
https://www.sentinelinitiative.org/methods-data-tools/methods/inclusion-semi-structured-and-unstructured-electronic-health-record-ehr
Inclusion of Semi-Structured and Unstructured Electronic Health Record (EHR) Data in Confounding Adjustment and Outcome Ascertainment
Methods, Data, & Tools
12/09/2022
Methods, Data, & Tools
12/09/2022
https://www.sentinelinitiative.org/methods-data-tools/methods/development-and-evaluation-electronic-health-record-ehr-information
Development and Evaluation of Electronic Health Record (EHR) Information Extraction Pipeline and Tree-Based Scan Statistic (TBSS) Methods for EHR-Based Signal Detection (DA2)
Methods, Data, & Tools
01/27/2023
Methods, Data, & Tools
01/27/2023
https://www.sentinelinitiative.org/methods-data-tools/methods/strengthening-inferential-studies-us-fda-sentinel-initiative
Strengthening Inferential Studies in the U.S. FDA Sentinel Initiative: A Methodological Demonstration Project
Methods, Data, & Tools
11/17/2023
Methods, Data, & Tools
11/17/2023
https://www.sentinelinitiative.org/methods-data-tools/methods/systematic-process-assessing-fitness-purpose-health-outcomes-computable
A Systematic Process for Assessing Fitness-for-Purpose of Health Outcomes for Computable Phenotyping with Electronic Health Records Data
Methods, Data, & Tools
11/17/2023
Methods, Data, & Tools
11/17/2023
https://www.sentinelinitiative.org/methods-data-tools/methods/development-and-refinement-toolkit-large-scale-covariate-adjustment
Development and Refinement of a Toolkit for Large Scale Covariate Adjustment in the Electronic Health Record and Claims Data Partner Network
Methods, Data, & Tools
12/15/2023
Methods, Data, & Tools
12/15/2023
https://www.sentinelinitiative.org/methods-data-tools/methods/empirical-application-sentinel-ehr-and-claims-data-partner-network
Empirical Application of the Sentinel EHR and Claims Data Partner Network to Enhance ARIA Sufficient Inferential Requests and Atypical Descriptive Requests (Use Case Package 2)
Methods, Data, & Tools
02/13/2024
Methods, Data, & Tools
02/13/2024
https://www.sentinelinitiative.org/studies/characterization-influenza-complications-among-individuals-diagnosed-influenza-illness
Characterization of Influenza Complications Among Individuals Diagnosed with Influenza‐Like Illness, Pneumonia and Influenza, and Medically Attended Acute Respiratory Illness: A Descriptive Analysis
Analyses
06/04/2024
Analyses
06/04/2024
https://www.sentinelinitiative.org/studies/drugs/individual-drug-analyses/intentional-self-harm-following-glucagon-peptide-1-receptor
Intentional Self-Harm Following Glucagon-like Peptide-1 Receptor Agonists (GLP-1 RA) Use in Patients with Diabetes: An Inverse Probability of Treatment Weighting Analysis
Analyses
07/22/2024
Analyses
07/22/2024
https://www.sentinelinitiative.org/studies/drugs/individual-drug-analyses/intentional-self-harm-following-glucagon-peptide-1-0
Intentional Self-Harm Following Glucagon-like Peptide-1 Receptor Agonists (GLP-1 RA) Use in Patients with Obesity: A Descriptive Analysis
Analyses
07/22/2024
Analyses
07/22/2024
https://www.sentinelinitiative.org/studies/drugs/individual-drug-analyses/duration-follow-new-molecular-entities-approved-2021-first
Duration of Follow Up for New Molecular Entities Approved in 2021: First Descriptive Analysis
Analyses
07/30/2024
Analyses
07/30/2024
https://www.sentinelinitiative.org/news-events/publications-presentations/lyme-disease-prophylaxis-single-dose-doxycycline-united
Lyme Disease Prophylaxis by Single-Dose Doxycycline in the United States, 2010–2020
Publications and Presentations
10/29/2024
Publications and Presentations
10/29/2024
https://www.sentinelinitiative.org/studies/drugs/individual-drug-analyses/trends-single-dose-doxycycline-lyme-disease-prophylaxis
Trends in Single-Dose Doxycycline for Lyme Disease Prophylaxis in the United States: A Second Descriptive Analysis
Analyses
11/06/2024
Analyses
11/06/2024
https://www.sentinelinitiative.org/studies/drugs/individual-drug-analyses/trends-single-dose-doxycycline-lyme-disease-prophylaxis-0
Trends in Single-Dose Doxycycline for Lyme Disease Prophylaxis in the United States: A Descriptive Analysis
Analyses
11/06/2024
Analyses
11/06/2024
https://www.sentinelinitiative.org/studies/drugs/individual-drug-analyses/characterization-confounding-covariates-trinetx-descriptive
Characterization of Confounding Covariates in TriNetX: A Descriptive Analysis
Analyses
05/16/2025
Analyses
05/16/2025
https://www.sentinelinitiative.org/studies/drugs/individual-drug-analyses/trends-single-dose-doxycycline-lyme-disease-prophylaxis-1
Trends in Single-Dose Doxycycline for Lyme Disease Prophylaxis in the United States: A Third Descriptive Analysis
Analyses
06/18/2025
Analyses
06/18/2025
https://www.sentinelinitiative.org/studies/drugs/individual-drug-analyses/rates-diabetic-ketoacidosis-dka-chronic-kidney-disease-ckd
Rates of Diabetic Ketoacidosis (DKA) by Chronic Kidney Disease (CKD) Stage Among Patients with Type 1 Diabetes Mellitus (T1DM): A Propensity Score Matched Analysis
Analyses
08/05/2025
Analyses
08/05/2025
https://www.sentinelinitiative.org/studies/drugs/individual-drug-analyses/characterization-confounding-covariates-sentinel-distributed
Characterization of Confounding Covariates in the Sentinel Distributed Database (SDD): A Descriptive Analysis
Analyses
08/21/2025
Analyses
08/21/2025
https://www.sentinelinitiative.org/studies/drugs/individual-drug-analyses/proportion-incident-syndrome-inappropriate-antidiuretic
Proportion of Incident Syndrome of Inappropriate Antidiuretic Hormone Secretion Cases with Evidence of Pulmonary Opportunistic Infections Among New Users of BIC/FTC/TAF: A Descriptive Analysis
Analyses
08/22/2025
Analyses
08/22/2025
https://www.sentinelinitiative.org/news-events/publications-presentations/characterization-confounding-covariate-data-capture-us-food
Characterization of Confounding Covariate Data Capture in the U.S. Food and Drug Administration’s Sentinel Distributed Database
Publications and Presentations
08/25/2025
Publications and Presentations
08/25/2025
https://www.sentinelinitiative.org/news-events/publications-presentations/single-dose-doxycycline-lyme-disease-prophylaxis-children
Single-Dose Doxycycline for Lyme Disease Prophylaxis in Children in a Large United States Healthcare Database, 2016-2020
Publications and Presentations
08/26/2025
Publications and Presentations
08/26/2025
https://www.sentinelinitiative.org/methods-data-tools/methods/use-case-2-uc2-aim-5-plasmode-simulation-based-quantitative-bias
Use Case 2 (UC2) Aim 5: Plasmode Simulation Based Quantitative Bias Analysis (QBA) for Unmeasured Confounding
Methods, Data, & Tools
09/05/2025
Methods, Data, & Tools
09/05/2025
https://www.sentinelinitiative.org/studies/drugs/biktarvy-bictegraviremtricitabinetenofovir-alafenamide
Biktarvy (Bictegravir/Emtricitabine/Tenofovir Alafenamide) & Signal Identification
Studies
09/12/2025
Studies
09/12/2025
https://www.sentinelinitiative.org/studies/drugs/new-molecular-entities-nmes
New Molecular Entities (NMEs) & Utilization Characterization
Studies
12/04/2025
Studies
12/04/2025
https://www.sentinelinitiative.org/studies/drugs/individual-drug-analyses/outcome-monitoring-following-faricimab-use-self-controlled
Outcome Monitoring Following Faricimab Use: A Self-Controlled Risk Interval Signal Identification Analysis
Analyses
12/10/2025
Analyses
12/10/2025
https://www.sentinelinitiative.org/news-events/publications-presentations/strengthening-inferential-studies-fda-sentinel-initiative
Strengthening Inferential Studies in the FDA Sentinel Initiative: Results from a Methodological Demonstration Project
Publications and Presentations
12/15/2025
Publications and Presentations
12/15/2025
https://www.sentinelinitiative.org/news-events/publications-presentations/enhancing-cause-death-prediction-development-and-validation
Enhancing Cause of Death Prediction: Development and Validation of Machine Learning Models Using Multimodal Data Across Multiple Health-Care Sites
Publications and Presentations
01/08/2026
Publications and Presentations
01/08/2026
https://www.sentinelinitiative.org/news-events/fda-safety-communications-labeling-changes/fda-requests-removal-suicidal-behavior-and
FDA Requests Removal of Suicidal Behavior and Ideation Warning from Glucagon-Like Peptide-1 Receptor Agonist (GLP-1 RA) Medications
Regulatory Impact
01/13/2026
Regulatory Impact
01/13/2026
https://www.sentinelinitiative.org/studies/drugs/individual-drug-analyses/intentional-self-harm-following-glucagon-peptide-1-2
Intentional Self-Harm Following Glucagon-Like Peptide 1 Receptor Agonists (GLP-1RA) Use in Patients with Diabetes & Obesity: A Descriptive Analysis
Analyses
01/26/2026
Analyses
01/26/2026
https://www.sentinelinitiative.org/studies/drugs/individual-drug-analyses/intentional-self-harm-following-glucagon-peptide-1-glp-1
Intentional Self-Harm Following Glucagon-Like Peptide 1 (GLP-1) Receptor Agonists Use in Patients 18 Years and Older: A Descriptive Analysis
Analyses
01/29/2026
Analyses
01/29/2026
https://www.sentinelinitiative.org/studies/drugs/assessing-arias-ability-evaluate-safety-concern/blujepa-gepotidacin
Assessment of ARIA Sufficiency: Blujepa (gepotidacin)
Sufficiency Assessments
01/30/2026
Sufficiency Assessments
01/30/2026
https://www.sentinelinitiative.org/studies/drugs/assessing-arias-ability-evaluate-safety-concern/nuzolvence-zoliflodacin
Assessment of ARIA Sufficiency: Nuzolvence (zoliflodacin)
Sufficiency Assessments
01/30/2026
Sufficiency Assessments
01/30/2026
https://www.sentinelinitiative.org/methods-data-tools/health-outcomes-interest/intentional-self-harm-algorithm-defined-intentional-3
Intentional Self-Harm Algorithm Defined in "Intentional Self-Harm Following Glucagon-like Peptide-1 Receptor Agonists (GLP-1 RA) Use in Patients with Diabetes, By Age and Sex Subgroups: An Inverse Probability of Treatment Weighting Analysis"
Methods, Data, & Tools
02/02/2026
Methods, Data, & Tools
02/02/2026
https://www.sentinelinitiative.org/studies/drugs/individual-drug-analyses/intentional-self-harm-following-glucagon-peptide-1-1
Intentional Self-Harm Following Glucagon-like Peptide-1 Receptor Agonists (GLP-1 RA) Use in Patients with Diabetes, By Age and Sex Subgroups: An Inverse Probability of Treatment Weighting Analysis
Analyses
02/02/2026
Analyses
02/02/2026
https://www.sentinelinitiative.org/studies/drugs/individual-drug-analyses/duration-follow-new-molecular-entities-approved-2021-second
Duration of Follow Up for New Molecular Entities Approved in 2021: Second Descriptive Analysis
Analyses
02/03/2026
Analyses
02/03/2026
https://www.sentinelinitiative.org/news-events/publications-presentations/assessing-treatment-effects-observational-data-missing-0
Assessing Treatment Effects in Observational Data With Missing Confounders: A Comparative Study of Practical Doubly-Robust and Traditional Missing Data Methods
Publications and Presentations
02/06/2026
Publications and Presentations
02/06/2026
https://www.sentinelinitiative.org/news-events/publications-presentations/use-clinical-notes-assess-neuropsychiatric-events-after
Use of Clinical Notes to Assess Neuropsychiatric Events After Montelukast Initiation
Publications and Presentations
02/12/2026
Publications and Presentations
02/12/2026
https://www.sentinelinitiative.org/studies/drugs/vabysmo-faricimab
Vabysmo (Faricimab) & Signal Identification
Studies
02/13/2026
Studies
02/13/2026
https://www.sentinelinitiative.org/news-events/publications-presentations/evaluating-unmeasured-confounding-factors-claims-data-using
Evaluating Unmeasured Confounding Factors in Claims Data Using Linked Electronic Health Records: A Proof-of-Principle Analysis
Publications and Presentations
02/18/2026
Publications and Presentations
02/18/2026
https://www.sentinelinitiative.org/studies/drugs/assessing-arias-ability-evaluate-safety-concern/symbravo-meloxicam-and-rizatriptan
Assessment of ARIA Sufficiency: Symbravo (meloxicam and rizatriptan)
Sufficiency Assessments
02/19/2026
Sufficiency Assessments
02/19/2026
https://www.sentinelinitiative.org/methods-data-tools/health-outcomes-interest/renal-cell-carcinoma-algorithm-defined-renal-cell
Renal Cell Carcinoma Algorithm Defined in "Renal Cell Carcinoma Following At Least 180 Days of Canagliflozin Use in Patients with Type 2 Diabetes Mellitus: A Clone-Censor-Weighted Analysis with Inverse Probability of Treatment Weighting for Active Comparators"
Methods, Data, & Tools
02/27/2026
Methods, Data, & Tools
02/27/2026
https://www.sentinelinitiative.org/studies/drugs/individual-drug-analyses/renal-cell-carcinoma-following-least-180-days-canagliflozin
Renal Cell Carcinoma Following At Least 180 Days of Canagliflozin Use in Patients with Type 2 Diabetes Mellitus: A Clone-Censor-Weighted Analysis with Inverse Probability of Treatment Weighting for Active Comparators
Analyses
02/27/2026
Analyses
02/27/2026
https://www.sentinelinitiative.org/news-events/publications-presentations/statistical-methods-harmonize-electronic-health-record-data
Statistical Methods to Harmonize Electronic Health Record Data Across Healthcare Systems: Case Study and Lessons Learned
Publications and Presentations
03/02/2026
Publications and Presentations
03/02/2026
https://www.sentinelinitiative.org/news-events/publications-presentations/active-surveillance-medical-product-use-fda-s-sentinel-0
Active Surveillance of Medical Product Use in the FDA’s Sentinel System: A Focus on Pediatric Populations
Publications and Presentations
03/02/2026
Publications and Presentations
03/02/2026
https://www.sentinelinitiative.org/studies/drugs/assessing-arias-ability-evaluate-safety-concern/myqorzo-aficamten
Assessment of ARIA Sufficiency: Myqorzo (aficamten)
Sufficiency Assessments
03/03/2026
Sufficiency Assessments
03/03/2026
https://www.sentinelinitiative.org/studies/drugs/fluoride
Fluoride & Utilization
Studies
03/04/2026
Studies
03/04/2026
https://www.sentinelinitiative.org/studies/drugs/individual-drug-analyses/utilization-orally-ingestible-systemic-sodium-fluoride
Utilization of Orally Ingestible Systemic Sodium Fluoride: A Descriptive Analysis
Analyses
03/04/2026
Analyses
03/04/2026
https://www.sentinelinitiative.org/studies/drugs/beta-blockers
Beta Blockers & Hypoglycemia
Studies
03/10/2026
Studies
03/10/2026
https://www.sentinelinitiative.org/studies/drugs/mother-infant-linkage-table
Mother-Infant Linkage Table & Characterization
Studies
03/10/2026
Studies
03/10/2026
https://www.sentinelinitiative.org/news-events/publications-presentations/characterization-and-comparison-structured-and-unstructured
Characterization and Comparison of Structured and Unstructured Electronic Health Record Data Mapped to MedDRA for Post-Marketing Surveillance
Publications and Presentations
03/11/2026
Publications and Presentations
03/11/2026
https://www.sentinelinitiative.org/news-events/publications-presentations/systematic-process-assessing-fitness-purpose-health-outcomes
A Systematic Process for Assessing Fitness-for-Purpose of Health Outcomes for Computable Phenotyping With Electronic Health Record Data
Publications and Presentations
03/12/2026
Publications and Presentations
03/12/2026
https://www.sentinelinitiative.org/news-events/publications-presentations/association-glp-1-receptor-agonists-intentional-self-harm
Association of GLP-1 Receptor Agonists with Intentional Self-Harm in Patients with Type 2 Diabetes: A Sentinel Distributed Database Study
Publications and Presentations
03/18/2026
Publications and Presentations
03/18/2026
https://www.sentinelinitiative.org/studies/drugs/doxycycline
Doxycycline & Lyme Disease
Studies
03/19/2026
Studies
03/19/2026
https://www.sentinelinitiative.org/studies/characterization-influenza-complications-among-individuals-diagnosed-influenza-illness-0
Characterization of Influenza Complications Among Individuals Diagnosed with Influenza-Like Illness in Outpatient, Ambulatory, and Emergency Department Settings: A Descriptive Analysis
Analyses
03/19/2026
Analyses
03/19/2026
https://www.sentinelinitiative.org/news-events/publications-presentations/serious-infection-crohns-disease-patients-treated
Serious Infection in Crohn's Disease Patients Treated With Ustekinumab: US Food and Drug Administration Active Postmarket Risk Identification and Analysis in the Sentinel Initiative
Publications and Presentations
03/24/2026
Publications and Presentations
03/24/2026
https://www.sentinelinitiative.org/studies/drugs/glucagon-peptide-1-receptor-agonists
Glucagon-Like Peptide-1 Receptor Agonists & Intentional Self-Harm
Studies
03/26/2026
Studies
03/26/2026
https://www.sentinelinitiative.org/studies/drugs/confounding-covariates
Confounding Covariates & Characterization
Studies
03/31/2026
Studies
03/31/2026
https://www.sentinelinitiative.org/methods-data-tools/health-outcomes-interest/serious-infection-algorithm-defined-serious-infection-0
Serious Infection Algorithm Defined in "Serious Infection Following Ustekinumab Use in Patients with Ulcerative Colitis: An Inverse Probability of Treatment Weighting Analysis"
Methods, Data, & Tools
04/03/2026
Methods, Data, & Tools
04/03/2026
https://www.sentinelinitiative.org/studies/drugs/individual-drug-analyses/serious-infection-following-ustekinumab-use-patients
Serious Infection Following Ustekinumab Use in Patients with Ulcerative Colitis: An Inverse Probability of Treatment Weighting Analysis
Analyses
04/03/2026
Analyses
04/03/2026
https://www.sentinelinitiative.org/studies/drugs/individual-drug-analyses/outcome-monitoring-following-ozempic-use-patients-type-2-0
Outcome Monitoring Following Ozempic Use in Patients with Type 2 Diabetes: An Active Comparator Signal Identification Analysis
Analyses
04/06/2026
Analyses
04/06/2026
https://www.sentinelinitiative.org/studies/drugs/motegrity-prucalopride
Motegrity (Prucalopride) & Signal Identification
Studies
04/06/2026
Studies
04/06/2026
https://www.sentinelinitiative.org/studies/drugs/trulance-plecanatide
Trulance (Plecanatide) & Signal Identification
Studies
04/06/2026
Studies
04/06/2026
https://www.sentinelinitiative.org/studies/drugs/semaglutide-injectables
Semaglutide Injectables & Signal Identification
Studies
04/06/2026
Studies
04/06/2026
https://www.sentinelinitiative.org/studies/drugs/individual-drug-analyses/outcome-monitoring-following-prucalopride-and-plecanatide
Outcome Monitoring Following Prucalopride and Plecanatide Use: An Active Comparator Signal Identification Analysis with Alternating Exposure-Comparator Roles
Analyses
04/06/2026
Analyses
04/06/2026
https://www.sentinelinitiative.org/studies/drugs/individual-drug-analyses/risk-gastrointestinal-hypomotility-constipation-or-gi
Risk of Gastrointestinal Hypomotility, Constipation, or GI Dysmotility with Serious Complications and Intentional Self-Harm in Individuals with Migraine Following Use of CGRP Inhibitors: A Propensity Score Matched Analysis
Analyses
04/07/2026
Analyses
04/07/2026
https://www.sentinelinitiative.org/studies/drugs/calcitonin-gene-related-peptide-cgrp-inhibitors
Calcitonin Gene-Related Peptide (CGRP) Inhibitors & Gastrointestinal Hypomotility, Constipation or GI dysmotility with Serious Complications and Intentional Self-Harm
Studies
04/07/2026
Studies
04/07/2026