Fendermal Use In Pregnancy & Lactation

Pregnancy: There are no adequate data from the use of fentanyl in pregnant women. Studies in animals have shown some reproductive toxicity (see Pharmacology: Toxicology: Preclinical safety data under Actions). The potential risk for humans is unknown, although fentanyl as an IV anaesthetic has been found to cross the placenta in human pregnancies. Neonatal withdrawal syndrome has been reported in newborn infants with chronic maternal use of fentanyl during pregnancy. Fentanyl should not be used during pregnancy unless clearly necessary.
Use of fentanyl patch during childbirth is not recommended because it should not be used in the management of acute or postoperative pain (see Contraindications). Moreover, because fentanyl passes through the placenta, the use of fentanyl patch during childbirth might result in respiratory depression in the newborn infant.
Breast-feeding: Fentanyl is excreted into human milk and may cause sedation/respiratory depression in a breastfed infant. Breastfeeding should therefore be discontinued during treatment with fentanyl patch and for at least 72 hours after removal of the patch.
Fertility: There are no clinical data on the effects of fentanyl on fertility. Some studies in rats have revealed reduced fertility and enhanced embryo mortality at maternally toxic doses (see Pharmacology: Toxicology: Preclinical safety data under Actions).