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Individual Drug Analyses

This page contains a complete list of all FDA analyses conducted in the Sentinel System from the start of Mini-Sentinel in 2009 to the present. 

The table below is organized at the individual analysis level (e.g., Level 1, Level 2, Query Builder, protocol-based assessment, etc.). It is designed to support searches for a specific analysis. 

Alternatively, the Drug Studies table groups together related analyses that FDA conducted to address a safety concern, or set of related safety concerns. The Drug Studies page also provides important background information and describes the regulatory impact.

Note: The appearance of a drug in a Sentinel study does not mean that FDA has concluded that a causal relationship exists between the drug and the health outcome of interest. Patients and healthcare providers should refer to FDA.gov for further information about drug safety.

FDA Sentinel Analyses from ARIA and Other Sentinel Data Sources

Title Medical Product Outcomes Date
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
Retrospective Inferential
calcitonin gene-related peptide (CGRP) Inhibitors
gastrointestinal (GI) hypomotility, constipation, or GI dysmotility with serious complications
intentional self-harm
Outcome Monitoring Following Prucalopride and Plecanatide Use: An Active Comparator Signal Identification Analysis with Alternating Exposure-Comparator Roles
plecanatide,
prucalopride
signal identification
Outcome Monitoring Following Ozempic Use in Patients with Type 2 Diabetes: An Active Comparator Signal Identification Analysis
Signal Identification
semaglutide injectables
Serious Infection Following Ustekinumab Use in Patients with Ulcerative Colitis: An Inverse Probability of Treatment Weighting Analysis
Retrospective Inferential
serious infection
Utilization of Orally Ingestible Systemic Sodium Fluoride: A Descriptive Analysis
Descriptive
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
Retrospective Inferential
renal cell carcinoma
Duration of Follow Up for New Molecular Entities Approved in 2021: Second Descriptive Analysis
Descriptive
new molecular entities (NMEs)
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
Retrospective Inferential
glucagon-like peptide-1 (GLP-1) receptor agonists
intentional self-harm
Intentional Self-Harm Following Glucagon-Like Peptide 1 (GLP-1) Receptor Agonists Use in Patients 18 Years and Older: A Descriptive Analysis
Descriptive
glucagon-like peptide-1 (GLP-1) receptor agonists
intentional self-harm
Intentional Self-Harm Following Glucagon-Like Peptide 1 Receptor Agonists (GLP-1RA) Use in Patients with Diabetes & Obesity: A Descriptive Analysis
Descriptive
glucagon-like peptide-1 (GLP-1) receptor agonists
intentional self-harm