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

Fentanyl has been assigned to pregnancy category C by the FDA. 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.

Fentanyl Breastfeeding Warnings

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.

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. Fentanyl is considered to be compatible with breast-feeding by the American Academy of Pediatrics.

See Also...

• Fentanyl use while Breastfeeding (in more detail)
• Fentanyl Consumer Information
• Pregnancy Support Group
• FDA Pregnancy Categories
• Medicine use during Pregnancy
• Medicine use while Breastfeeding
• Safe Medications during Breastfeeding

Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Wolters Kluwer Health and Drugs.com is accurate, up-to-date, and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This drug information does not endorse drugs, diagnose patients, or recommend therapy. This drug information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug of drug combination is safe, effective, or appropriate for any given patient. Multum Information Services, Inc. does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. Copyright 2000-2008 Multum Information Services, Inc. The information in contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse, or pharmacist.