Pregnancy & Lactation : הריון/הנקה

4.6 Fertility, Pregnancy and lactation

Pregnancy
Insufficient data are available on midazolam to assess its safety during pregnancy. Animal studies do not indicate a teratogenic effect, but foetotoxicity was observed as with other benzodiazepines.

An increased risk of congenital malformation associated with the use of benzodiazepines during the first trimester of pregnancy has been suggested.

The administration of high doses of midazolam in the last trimester of pregnancy, during labour or when used as an induction agent of anaesthesia for caesarean section has been reported to produce maternal or foetal adverse effects (inhalation risk in mother, irregularities in the foetal heart rate, hypotonia, poor sucking, hypothermia and respiratory depression in the neonate).

Moreover, infants born from mothers who received benzodiazepines chronically during the latter stage of pregnancy may have developed physical dependence and may be at some risk of developing withdrawal symptoms in the postnatal period.

Consequently, midazolam may be used during pregnancy if clearly necessary but it is preferable to avoid using it for caesarean.

The risk for neonate should be taken into account in case of administration of midazolam for any surgery near the term.

Breast-feeding

Midazolam passes in low quantities into breast milk. Nursing mothers should be advised to discontinue breast-feeding for 24 hours following administration of midazolam.