• Biologics. Etanercept, adalimumab, infliximab, and alefacept are all category B drugs in pregnancy. There are some hints that they, as well as tumor necrosis factor (TNF)-inhibitors, may be associated with some fetal anomalies in the VACTERL association cluster (vertebral defects, anal atresia, cardiac defects, tracheoesophageal fistula, renal anomalies, and limb abnormalities). A confirmation of the syndrome requires three signs to be present. Only two infants born to mothers taking a biologic have had three qualifying signs.
However, pregnancy outcome reports for the drugs have recorded malformations. Among the adalimumab cohorts totaling 256 pregnancies, there were 14 fetal anomalies (5.5%); of these, nine were VACTERL-related. In the etanercept cohorts totaling 204 pregnancies, there were 13 anomalies (6.4%); of these, six were VACTERL-related. In the infliximab cohorts totaling 112 pregnancies, there was only one anomaly, which was in the VACTERL cluster. Among the 407 pregnancies in the TNF-inhibitors, there were three anomalies, none of which were related to VACTERL.
Dr. Murase had no financial disclosures relevant to her talk.
The current system of using letter categories to denote risk of prescription drugs during pregnancy and breastfeeding is being replaced by the Food and Drug Administration, with the addition of subsections in drug labeling.