TNF-Alpha Inhibitors & Exposure in Pregnancy

Basic Details
Status
Complete
Last Updated
Thursday, December 21, 2017
Health Outcome(s)
exposure in pregnancy
Purpose
Drug Use
Meets requirements of FD&C Act Sec 505(o) prior to requiring a PMR
No
Regulatory Determination / Use

Drug Safety Label Change, Pregnancy and Lactation

Result(s) (1)
Anti-Tumor Necrosis Factor (TNF) Utilization Among Pregnant Women
Regulatory Link(s) (1)
FDA Drug Safety Labeling Changes Page Enbrel (etanercept)
Related Publication(s) and/or Presentation(s) (2)
Publication: Use of Tumor Necrosis Factor-alpha Inhibitors During Pregnancy Among Women Who Delivered Liveborn Infants Presentation: Tumor Necrosis Factor-alpha Inhibitor (TNFi) Utilization among Women with Live Birth
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