Are Tumor Necrosis Factor Antagonists Safe in Pregnancy?

A retrospective look at the FDA database leads authors to conclude that these agents are unsafe in pregnancy; editorialists say it ain’t necessarily so.

Tumor necrosis factor (TNF) antagonists are labeled pregnancy category B, but their use has not been well studied in pregnant patients. These authors retrospectively evaluated reports of adverse events in the FDA database to study pregnancy outcomes in recipients of TNF antagonists.

The authors identified 61 congenital anomalies that occurred in 41 children born to mothers taking TNF antagonists. They propose that 24 of the 41 babies had VACTERL anomalies (vertebral abnormalities, anal atresia, cardiac defects, tracheoesophageal, renal, and limb abnormalities). They conclude that this incidence is higher than expected when measured against occurrences in historical controls.

The authors of an accompanying editorial clearly lay out the problem…

Reviewing Author

Jeffrey P. Callen, MD

Disclosures

Consultant / Advisory board XOMA; Eli Lilly; Celgene

Equity Various trust accounts

Editorial boards JAMA Dermatology; UpToDate

Leadership positions in professional societies Association of Professors of Dermatology (President-Elect)