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Uloric (Febuxostat) & Duration of Use and User Characteristics

Basic Details
Status
Complete
Last Updated
Thursday, November 12, 2020
Original Posting Date
Health Outcome(s)
duration of use
user characteristics
Purpose
Drug Utilization
Meets requirements of FD&C Act Sec 505(o) prior to requiring a PMR
No
Study Summary

FDA conducted a study to further investigate a post-market clinical trial that identified an elevated risk of cardiovascular events. Sentinel was used to describe the real-world utilization of urate lowering therapies to help inform the committee’s determination that a population exists for whom the benefit-risk is favorable.

Result(s) (2)
Characteristics of Gout Patients and Use of Urate-Lowering Therapies Counts of Individuals with Gout Using Urate-Lowering Therapy (ULT) and Switching between ULT Products: A Descriptive Analysis
Regulatory Link(s) (1)
Joint Meeting: Arthritis Advisory Committee (AAC) and Drug Safety and Risk Management (DSaRM) Advisory Committee Materials
Related Publication(s) and/or Presentation(s) (1)
Presentation: Characteristics of Febuxostat and Allopurinol Initiators and Utilization Patterns in Real-World Settings