Fentora Use In Pregnancy & Lactation

Pregnancy: There are no adequate data from the use of fentanyl in pregnant women. Studies in animals have shown reproductive toxicity (see Pharmacology: Toxicology: Preclinical safety data under Actions). The potential risk for humans is unknown. Fentora should not be used in pregnancy unless clearly necessary.
Following long-term treatment, fentanyl may cause withdrawal in the new-born infant.
It is advised not to use fentanyl during labour and delivery (including caesarean section) because fentanyl passes through the placenta and may cause respiratory depression in the foetus. If Fentora is administered, an antidote for the child should be readily available.
Breast-feeding: Fentanyl passes into breast milk and may cause sedation and respiratory depression in the breast-fed child. Fentanyl should not be used by breastfeeding women and breastfeeding should not be restarted until at least 48 hours after the last administration of fentanyl.
Fertility: There are no human data on fertility available. In animal studies, male fertility was impaired (see Pharmacology: Toxicology: Preclinical safety data under Actions).