TNF-Alpha Inhibitors & Use in Pregnancy

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

    As part of FDA’s routine review of postmarketing studies, FDA conducted a drug utilization analysis of TNF alpha inhibitors in pregnant women in the Sentinel System. The study found that among pregnant women with a chronic inflammatory condition (ankylosing spondylitis, juvenile idiopathic arthritis, psoriatic arthritis, psoriasis, rheumatoid arthritis), there was a preference to use etanercept compared to other TNF alpha inhibitors. For most TNF alpha inhibitors, use during pregnancy decreased after the first trimester. This assessment was one source of evidence considered for the Pregnancy and Lactation Labeling Rule (PLLR) Conversion Safety Labeling Change for Enbrel (etanercept).