Stelara (Ustekinumab) & Serious Infection

Details

Basic Details

Status

Ongoing

Last Updated

Thursday, March 7, 2024

Original Posting Date

Friday, October 18, 2019

Health Outcome(s)

serious infection (Crohn’s disease)

serious infection (ulcerative colitis)

Purpose

Drug and Outcome Analysis

Meets requirements of FD&C Act Sec 505(o) prior to requiring a PMR

Yes

Result(s) (3)

Ustekinumab Dispensing Patterns: A Descriptive Analysis Serious Infection Following Ustekinumab Use in Patients with Crohn’s Disease or Ulcerative Colitis: A Descriptive Analysis Ustekinumab and Comparator Treatment Utilization and Pneumonia Outcomes in Patients with Crohn's Disease or Ulcerative Colitis: An Updated Descriptive Analysis

Regulatory Link(s) (1)

FDA Approval Package Materials