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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
Dihydropyrimidine Dehydrogenase (DPYD) Gene Variant Testing Rates and Fluoropyrimidine Use Following Pharmacogenetic Testing Among Incident Fluoropyrimidine Users: A Descriptive Analysis
Descriptive
Characterization of the Sentinel Prescribing and Dispensing Tables: A Descriptive Analysis
Descriptive
Outcome Monitoring Following Infliximab Biosimilar Product Use: An Active Comparator Signal Identification Analysis
Signal Identification
infliximab biosimilars
Mortality Following Long-Acting Injectable Antipsychotics Use: A Third Inverse Probability of Treatment Weighting Analysis
Retrospective Inferential
long-acting injectable antipsychotics
mortality
Mortality Following Long-Acting Injectable Antipsychotics Use: An Updated Inverse Probability of Treatment Weighting Analysis
Retrospective Inferential
long-acting injectable antipsychotics
mortality
Counts of and Characterization of Mortality Capture Among Long-Acting Injectable Antipsychotic (LAIA) Users: A Descriptive Analysis
Descriptive
long-acting injectable antipsychotics
mortality
Use of Combined Hormonal Contraceptives or Progestin-only Contraceptives During 6-month Postpartum Period and the Risk of Venous Thromboembolism: A Propensity Score Matched Analysis
Retrospective Inferential
combined hormonal contraceptives (CHCs),
progestin-only contraceptives (POCs)
venous thromboembolism
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