Can I take methadone while pregnant or breastfeeding?

8.1 Pregnancy Risk Summary The majority of available data from clinical trials, observational studies, case series, and case reports on methadone use in pregnancy do not indicate an increased risk of major malformations specifically due to methadone. Pregnant women involved in methadone maintenance programs have been reported to have improved prenatal care leading to reduced incidence of obstetric and fetal complications and neonatal morbidity and mortality when compared to women using illicit drugs. Several factors, including maternal use of illicit drugs, nutrition, infection and psychosocial circumstances, complicate the interpretation of investigations of the children of women who take methadone during pregnancy. Information is limited regarding dose and duration of methadone use during pregnancy, and most maternal exposure in these studies appears to occur after the first trimester of pregnancy (see Data). Neonatal opioid withdrawal syndrome (NOWS) is an expected and treatable outcome of use of opioids for an extended period of time during pregnancy [see Warnings and Precautions (5.7) ].

Prescribing label, section “8.1 Pregnancy” (opening excerpt): Methadone Hydrochloride (oral), American Health Packaging. Read the full section on DailyMed. Quoted verbatim; US labels are written for US prescribers and patients.

Maternal use of oral opioids during breastfeeding can cause infant drowsiness, which may progress to rare but severe central nervous system depression. Newborn infants seem to be particularly sensitive to the effects of even small dosages of narcotic analgesics. If the mother of a newborn requires methadone, it is not a reason to discontinue breastfeeding; however, once the mother's milk comes in, it is best to provide pain control with a nonnarcotic analgesic and limit maternal intake of oral methadone to 2 to 3 days. Most infants receive an estimated dose of methadone ranging from 1 to 3% of the mother's weight-adjusted methadone dosage with a few receiving 5 to 6%, which is less than the dosage used for treating neonatal abstinence. Initiation of methadone postpartum or increasing the maternal dosage to greater than 100 mg daily therapeutically or by abuse while breastfeeding poses a risk of sedation and respiratory depression in the breastfed infant, especially if the infant was not exposed to methadone in utero. Several deaths of breastfed infants exposed to methadone in milk have been reported. If the baby shows signs of increased sleepiness (more than usual), breathing difficulties, or limpness, a physician should be contacted immediately. Other agents are preferred over methadone for pain control during breastfeeding. Withdrawal symptoms can occur in breastfed infants when maternal administration of an opioid analgesic is stopped, or when breastfeeding is stopped.

Women who received methadone maintenance during pregnancy and are stable should be encouraged to breastfeed their infants postpartum, unless there is another contraindication, such as use of street drugs.[1-12] Women receiving antenatal buprenorphine or buprenorphine-naloxone are more likely to initiate breastfeeding postpartum than those receiving methadone.[13] Breastfeeding may decrease, but not eliminate, neonatal withdrawal symptoms in infants who were exposed in utero. Some studies have found shorter hospital stays, durations of neonatal abstinence therapy and shorter durations of therapy among breastfed infants, although the dosage of opiates used for neonatal abstinence may not be reduced.[8,9,11,14-21] The long-term outcome of infants breastfed during maternal methadone therapy for opiate abuse has not been well studied.[22] Abrupt weaning of breastfed infants of women on methadone maintenance might result in precipitation of or an increase in infant withdrawal symptoms, and gradual weaning is advised. The breastfeeding rate among mothers taking methadone for opiate dependency has been lower than in mothers not using methadone in some studies, but this finding appears to vary by institution, indicating that other factors may be important.

“Summary of Use during Lactation”, LactMed record “Methadone” (LM367), quoted verbatim. Everything LactMed reports about Methadone while breastfeeding.

8.2 Lactation Risk Summary Based on two small clinical studies, methadone was present in low levels in human milk, but the exposed infants in these studies did not show adverse reactions. Based on an average milk consumption of 150 mL/kg/day, an infant would consume approximately 17.4 mcg/kg/day which is approximately 2 to 3% of the oral maternal dose. There have been rare case reports of sedation and respiratory depression in infants exposed to methadone through breast milk (see Data). Monitor infants exposed to methadone hydrochloride through breastmilk for excess sedation and respiratory depression. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for methadone and any potential adverse effects on the breastfed child from the drug or from the underlying maternal condition. Data In a study of ten breastfeeding women maintained on oral methadone doses of 10 to 80 mg/day, methadone concentrations from 50 to 570 mcg/L in milk were reported, which, in the majority of samples, were lower than maternal serum drug concentrations at steady state.

Prescribing label, section “8.2 Lactation” (opening excerpt): Methadone Hydrochloride (oral), American Health Packaging. Read the full section on DailyMed. Quoted verbatim; US labels are written for US prescribers and patients.