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Interleukin-1/-6 Inhibitors & Interstitial Lung Disease and Pulmonary Arterial Hypertension

Basic Details
Status
Complete
Last Updated
Monday, December 3, 2018
Health Outcome(s)
interstitial lung disease
pulmonary arterial hypertension
Purpose
Drug and Outcome Analysis
Meets requirements of FD&C Act Sec 505(o) prior to requiring a PMR
No
Study Summary

Feasibility assessment of ARIA to conduct a postmarket safety study. FDA decided that no action is necessary at this time, based on available information.

Result(s) (1)
Pulmonary Arterial Hypertension and Interstitial Lung Disease Events Among Interleukin Inhibitor Users