Fentanyl Pregnancy and Breastfeeding Warnings
Fentanyl Pregnancy Warnings
Use of this drug is not recommended unless the benefit outweighs the risk to the developing fetus. Comments: -Prolonged use of opioids during pregnancy can result in physical dependence in the neonate; women should be advised of the risk of neonatal abstinence syndrome and ensure that appropriate treatment will be available. -There is insufficient data to support use of this during and labor and delivery; if this drug is administered, an antidote for the child should be readily available. AU TGA pregnancy category: C US FDA pregnancy category: C
Animal studies have failed to reveal evidence of teratogenicity; however, some reproductive toxicity has been reported. Maternal use of fentanyl may cause withdrawal symptoms and respiratory depression in the newborn infant. There are no controlled data in human pregnancy. In women treated acutely with IV 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 IV 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. AU TGA pregnancy category C: Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. Accompanying texts should be consulted for further details. US 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
This drug 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. Symptoms of opioid withdrawal may occur in infants at the cessation of nursing. One small study has reported the pharmacokinetic data of five lactating women who underwent induction of anesthesia with this drug. 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.
This drug should not be used unless there are no safer alternatives. Excreted into human milk: Yes Comments: -General manufacturer recommendations: 1) Lozenge: Breast-feeding is not recommended for at least 48 hours after the last dose. 2) IV or IM: Breast-feeding is not recommended for at least 24 hours after the last dose. 3) Transdermal patch: Breast-feeding is not recommended for at least 72 hours after the last dose. -This drug considered compatible with breastfeeding by the American Academy of Pediatrics. -This drug may cause sedation and respiratory depression in the breastfed child.
References for pregnancy information
- Koren G, Pastuszak A, Ito S "Drugs in pregnancy." N Engl J Med 338 (1998): 1128-37
- Rementeria JL, Nunag NN "Narcotic withdrawal in pregnancy: stillbirth incidence with a case report." Am J Obstet Gynecol 116 (1973): 1152-6
- "Product Information. Sublimaze (fentanyl)." Janssen Pharmaceutica, Titusville, NJ.
- Viscomi CM, Hood DD, Melone PJ, Eisenach JC "Fetal heart rate variability after epidural fentanyl during labor." Anesth Analg 71 (1990): 679-83
- Cerner Multum, Inc. "Australian Product Information." O 0
- "Product Information. Fentanyl Oralet (fentanyl)." Abbott Pharmaceutical, Abbott Park, IL.
- Zelson C, Lee SJ, Casalino M "Neonatal narcotic addiction: comparative effects of maternal intake of heroin and methadone." N Engl J Med 289 (1973): 1216-20
References for breastfeeding information
- Steer PL, Biddle CJ, Marley WS, Lantz RK, Sulik PL "Concentration of fentanyl in colostrum after an analgesic dose." Can J Anaesth 39 (1992): 231-5
- Leuschen MP, Wolf LJ, Rayburn WF "Fentanyl excretion in breast milk." Clin Pharm 9 (1990): 336-7
- Committee on Drugs, 1992 to 1993 "The transfer of drugs and other chemicals into human milk." Pediatrics 93 (1994): 137-50
- Nitsun M, Szokol JW, Saleh HJ, et al. "Pharmacokinetics of midazolam, propofol, and fentanyl transfer to human breast milk." Clin Pharmacol Ther 79 (2006): 549-557
- Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
- Cerner Multum, Inc. "Australian Product Information." O 0
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