Pregnancy & Lactation : הריון/הנקה

4.6      Fertility, pregnancy and lactation
Fertility
Corticosteroids have been shown to impair fertility in animal studies (see section 5.3).

Pregnancy
Methylprednisolone
The ability of corticosteroids to cross the placenta varies between individual drugs, however, methylprednisolone does cross the placenta. One retrospective study found an increased incidence of low birth weights in infants born of mothers receiving corticosteroids. In humans, the risk of low birth weight appears to be dose related and may be minimized by administering lower corticosteroid doses.

Administration of corticosteroids to pregnant animals can cause abnormalities of foetal development including cleft palate, intra-uterine growth retardation and affects on brain growth and development. There is no evidence that corticosteroids result in an increased incidence of congenital abnormalities, such as cleft palate in man, however, when administered for long periods or repeatedly during pregnancy, corticosteroids may increase the risk of intra-uterine growth retardation. Hypoadrenalism may, in theory, occur in the neonate following prenatal exposure to corticosteroids but usually resolves spontaneously following birth and is rarely clinically important. Although neonatal adrenal insufficiency appears to be rare in infants who were exposed in utero to corticosteroids, those exposed to substantial doses of corticosteroids must be carefully observed and evaluated for signs of adrenal insufficiency. As with all drugs, corticosteroids should only be prescribed when the benefits to the mother and child outweigh the risks. When corticosteroids are essential, however, patients with normal pregnancies may be treated as though they were in the non- gravid state. However, corticosteroids do not appear to cause congenital anomalies when given to pregnant women.

Cataracts have been observed in infants born to mothers treated with long-term corticosteroids during pregnancy.

Lidocaine
The use of local anaesthetics such as lidocaine during labour and delivery may be associated with adverse effects on mother and foetus.

Lidocaine readily crosses the placenta.

Methylprednisolone acetate with lidocaine
Since adequate human reproductive studies have not been done with methylprednisolone acetate with lidocaine, this medicinal product should be used during pregnancy only after a careful assessment of the benefit-risk ratio to the mother and fetus.


Depo-Medrol with Lidocaine contains benzyl alcohol as a preservative. Benzyl alcohol can cross the placenta (see section 4.4).

Breast-feeding
Methylprednisolone

Corticosteroids are distributed in small amounts in breast milk and may suppress growth and interfere with endogenous glucocorticoid production in nursing infants. However, doses of up to 40 mg daily of methylprednisolone are unlikely to cause systemic effects in the infant.
Infants of mothers taking higher doses than this may have a degree of adrenal suppression.

Lidocaine
Lidocaine is excreted in human breast milk.
Methylprednisolone acetate with lidocaine
This medicinal product should be used during breast feeding only after a careful assessment of the benefit-risk ratio to the mother and infant.
Depo-Medrol with Lidocaine contains benzyl alcohol as a preservative (see section 4.4).