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).
Regulatory Link(s) (1)FDA Labeling Change: Etanercept (Enbrel) and Use in Pregnancy