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Methadone Pregnancy and Breastfeeding Warnings

Methadone is also known as: Dolophine, Methadone Diskets, Methadose, Methadose Sugar-Free

Methadone Pregnancy Warnings

This drug should be used during pregnancy only if the benefit clearly outweighs the risk to the fetus.

AU TGA pregnancy category: C
US FDA pregnancy category: C

-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.
-Due to pharmacokinetic differences during pregnancy, the methadone dose may need to be increased or dosing interval decreased in order to achieve therapeutic effectiveness.
-This drug should not be used during and immediately prior to labor, when short acting analgesics or other analgesic techniques are more appropriate.

Studies have shown the benefits of pharmacotherapy for opioid use disorder (OUD) during pregnancy outweigh the risks of untreated OUD. Treatment of OUD helps to block the cyclic withdrawal symptoms associated with misuse of opioids and provide a more stabilized intrauterine environment. Untreated opioid addiction is associated with adverse obstetrical outcomes such as low birth weight, preterm birth, and fetal death; untreated opioid addiction often results in continued or relapsing illicit opioid use. An expert review of published data by TERIS (Teratogen Information System) concludes that maternal use during pregnancy as part of a supervised, therapeutic regimen is unlikely to pose a substantial teratogenic risk. The relevance of these findings to the use of this drug in chronic pain patients is unclear.

Neonatal opioid withdrawal syndrome is an expected and treatable outcome of prolonged use during pregnancy. Several studies have reported decreased fetal growth in infants born to narcotic-addicted women treated with methadone during all or part of their pregnancy; however, this growth deficit does not appear to persist into later childhood. Mild but persistent deficits in performance on psychometric and behavioral tests have been demonstrated. There is conflicting data on whether the risk of sudden infant death syndrome is increased. There are no controlled studies of methadone use in pregnant women.

Chronic use of opioids may cause reduced fertility in females and males of reproductive potential; it is not known whether these effects on fertility are reversible. Reproductive function in human males may be decreased; reduced ejaculate volume, seminal vesicle and prostate secretions have been reported as well as reductions in serum testosterone levels, sperm motility, and abnormalities in sperm morphology.

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.

See references

Methadone Breastfeeding Warnings

Peak methadone levels occur about 4 to 5 hours after an oral dose. A breastfed infant would receive approximately 17.4 mcg/kg/day based on average milk consumption of 150 mL/kg/day; this is approximately 2% to 3% the oral maternal dose. Methadone concentrations from 50 to 570 mcg/L were observed in assays of breast milk from mothers maintained on oral methadone doses of 10 to 80 mg/day. Cases of sedation and respiratory depression in breastfed infants exposed to methadone have been received. There is no information on use of parenteral methadone in breastfeeding, or the safety of high dose methadone typically used for chronic pain management.

Pregnant mothers need to know when they should or should not breastfeed; a stable mother being treated for opioid use disorder is encouraged to breastfeed, although there are situations where breastfeeding is not recommended (e.g., the mother is HIV-positive, has tuberculosis, has cracked or bleeding nipples, is hepatitis C-positive, has returned to illicit drug use including cannabis). If breastfeeding is being considered, counseling should include:
-How to identify respiratory depression and sedation in their babies and when it may be necessary to seek immediate medical care; mothers should be aware that methadone will be transferred to breast milk.
-The possibility that the baby may experience methadone withdrawal if breast-feeding is discontinued suddenly; mothers should discuss discontinuation of breast-feeding with the baby's healthcare team.
-Use of other substances of abuse will expose the baby to additional risks; if other substances of abuse are being used, mothers should not breast-feed.

Use is considered acceptable; caution is recommended

Excreted into human milk: Yes

-Initiation of methadone postpartum, or increasing the maternal dosage to greater than 100 mg/day (therapeutically or by abuse) poses a risk of sedation and respiratory depression in the breastfed infant, especially if the infant was not exposed to methadone in utero.
-Women who received methadone maintenance during pregnancy and are stable should be encouraged to breastfeed unless there is another contraindication; nursing mothers will need ongoing support during this period.
-Breastfed infants should be monitored closely for signs of increased sleepiness and breathing difficulties; breastfeeding may decrease, but not eliminate neonatal withdrawal symptoms in infants exposed in utero.
-Breastfed infants of mothers using methadone should be weaned gradually to prevent development of withdrawal symptoms.

See references

References for pregnancy information

  1. Cerner Multum, Inc. "Australian Product Information." O 0
  2. Substance Abuse and Mental Health Services Administration "Clinical Guidance for Treating Pregnant and Parenting Women With Opioid Use Disorder and Their Infants . HHS Publication No. (SMA) 18-5054. Available from: URL:" (2018):
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  4. "Product Information. Diskets (methadone)." Cebert Pharmaceuticals Inc, Birmingham, AL.
  5. "Product Information. Dolophine (methadone)." Lilly, Eli and Company, Indianapolis, IN.

References for breastfeeding information

  1. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL:" ([cited 2013 -]):
  2. "Product Information. Diskets (methadone)." Cebert Pharmaceuticals Inc, Birmingham, AL.
  3. "Product Information. Dolophine (methadone)." Lilly, Eli and Company, Indianapolis, IN.
  4. Cerner Multum, Inc. "Australian Product Information." O 0
  5. Substance Abuse and Mental Health Services Administration "Clinical Guidance for Treating Pregnant and Parenting Women With Opioid Use Disorder and Their Infants . HHS Publication No. (SMA) 18-5054. Available from: URL:" (2018):

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.