Table 4.
Drug | Characteristics | FDA |
---|---|---|
Usually considered as safe, when needed | ||
Acetyl salicylate | Low doses during pregnancy needed for the treatment of diverse medical conditions have not been shown to cause foetal harm; may be protective against pre-eclampsia, favoring placentation (see text); discontinuation before delivery is recommended [161–163, 223, 224] | NC |
LMWH | Low molecular-weight heparin (LMWH) does not cross the placenta and is safe for the foetus, although bleeding at the utero-placental junction cannot be rued out. Individualized doses of LMWH are well tolerated and safe for prophylaxis and treatment of thromboembolic complications during pregnancy, and post-partum [355]. Twice-daily heparin should be discontinued prior to induction of labour or planned cesarean delivery and can be resumed after delivery [355, 356] | C |
ESAs | In vitro studies suggest that recombinant erythropoietin does not cross the human placenta; higher doses may be needed in dialysis patients [357, 358] | C |
Allopurinol | Adverse events were observed in animal studies. Allopurinol crosses the placenta [359]. An increased risk of malformations events has not been observed in humans (limited data) [360] | C |
Vitamin D | The role for vitamin D supplementation in pregnancy is controversial, but there is no evidence of a reduction in adverse pregnancy outcomes (e.g., preeclampsia, stillbirth, neonatal death) [361] or improvement in bone mineral content in children in studies in which supplementation was given independently from blood levels [362]. Cholecalciferol (vitamin D3) crosses the placenta but the transfer to the foetus from the mother is low. Maternal supplementation has not been shown to affect pregnancy outcomes [363]. Ergocalciferol Adverse events were observed in animal studies. The ergocalciferol (vitamin D2) metabolite, 25(OH) D, crosses the placenta; maternal serum concentrations correlate with foetal concentrations at birth. Calcitriol Teratogenic effects have been observed in animal studies. Adverse effects on foetal development were not observed in women (N = 9) with pseudovitamin D-dependent rickets. Paricalcitol Adverse events were observed in some animal reproduction studies Vitamin D deficiency in a pregnant woman may lead to deficiency in the neonate [364, 365]. Serum 25(OH) D concentrations should be measured in pregnant women at increased risk of deficiency [366]. Current guidelines recommend an intake of 1000–2000 units/day until more safety data is available [366, 367]. Vitamin D and calcium levels should be monitored and kept in the lower normal range |
C |
FDA Classification [340]: A, controlled human studies show no risk; B, no evidence of risk in studies; C, risk cannot be ruled out; D, positive evidence of risk; X, contraindicated in pregnancy; NC, not classified