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Fentanyl Pregnancy and Breastfeeding Warnings

Fentanyl is also known as: Abstral, Actiq, Duragesic, Duragesic-100, Duragesic-12, Duragesic-25, Duragesic-50, Duragesic-75, Fentanyl Transdermal System, Fentora, Ionsys, Lazanda, Onsolis, Sublimaze, Subsys

Fentanyl Pregnancy Warnings

FDA pregnancy category: C Use of fentanyl is not recommended unless the benefit outweighs the risk to the developing fetus.

Animal studies have revealed evidence of decreased fertility, embryotoxicity, fetotoxicity, and embryolethality. There are no controlled data in human pregnancy. Fentanyl should only be used in pregnancy when benefit outweighs risk. In women treated acutely with intravenous or epidural fentanyl during labor, symptoms of neonatal respiratory or neurological depression were no more frequent than would be expected in infants of untreated mothers. Transient neonatal muscular rigidity has been reported in infants whose mothers were treated with intravenous fentanyl. Chronic maternal treatment with fentanyl during pregnancy has been associated with transient respiratory depression, behavioral changes, or seizures in newborn infants characteristic of neonatal abstinence syndrome. FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

Fentanyl Breastfeeding Warnings

Fentanyl is excreted into human milk and achieves levels in colostrum which are greater than maternal serum levels. No adverse effects have been reported in nursing infants. The manufacturer has stated that symptoms of opioid withdrawal may occur in infants at the cessation of nursing by women using fentanyl and recommends that fentanyl not be used by nursing women. One small study has reported the pharmacokinetic data of five lactating women who underwent induction of anesthesia with fentanyl. In 24 hours of milk collection, an average of 0.033% (0.006% to 0.073%) of the maternal fentanyl was collected in the milk representing an average of 0.039% of the elimination clearance of the drug. The author of the study concluded that the amount of fentanyl excreted into the milk within 24 hours of induction of anesthesia provided insufficient justification to interrupt breast-feeding.

Use of fentanyl is not recommended. Excreted into human milk: Yes Excreted into animal milk: Data not available The manufacturer states that fentanyl is not recommended for use in nursing infants; however, fentanyl is considered to be generally compatible with breast-feeding by the American Academy of Pediatrics.

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