Durogesic Patch Use In Pregnancy & Lactation

Pregnancy: There are no adequate data from the use of DUROGESIC in pregnant women. Studies in animals have shown some reproductive toxicity (see Pharmacology: Toxicology: Non-clinical information under Actions). The potential risk for humans is unknown, although fentanyl as an IV anesthetic has been found to cross the placenta in early human pregnancies. Neonatal withdrawal syndrome has been reported in newborn infants with chronic maternal use of DUROGESIC during pregnancy. DUROGESIC should not be used during pregnancy unless clearly necessary.
Use of DUROGESIC 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 DUROGESIC 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 breastfed infant. Therefore, DUROGESIC is not recommended for use in breast-feeding women.