Table 6.
Category D drug |
No significant increase of congenital anomalies |
Incidence of major malformations – 4% to 12% |
Ebstein's anomaly risk 20 to 40 times the risk in general population |
Ebstein's anomaly – 0.05% to 0.1% |
Premature delivery |
Floppy infant syndrome |
Transient neurodevelopmental deficits |
NDI |
Thyroid dysfunctions |
Polyhydramnios (rare) |
Infant serum one quarter the concentration of lithium in maternal serum |
Not many reports of detrimental effects in newborns |
Reports of lethargy, hypothermia, hypotonia and T-wave modifications |
AAP recommendation – breast-feeding with caution |
Serum lithium and CBC monitoring of infant |