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Methadone Pregnancy and Breastfeeding Warnings

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

Methadone Pregnancy Warnings

Methadone has been assigned to pregnancy category C by the FDA. No increase in congenital defects has been observed with methadone treatment although withdrawal symptoms occur in 60% to 90% of infants born to mothers on chronic methadone therapy. There are no controlled data in human pregnancy. Methadone should only be given during pregnancy when benefit outweighs risk.

Offspring of methadone users are at increased risk for mortality, sudden infant death syndrome, jaundice, and thrombocytosis. Reproductive function in human males may be decreased by methadone treatment. Reductions in ejaculate volume and both seminal vesicle and prostate secretions have been reported in methadone-treated individuals. In addition, abnormalities in sperm morphology and reductions in both serum testosterone levels and sperm motility have been reported. Animal studies have provided additional data indicating that methadone treatment of males can alter reproductive function. Animal studies have reported a significant regression of sex accessory organs and testes. Additional animal data have been published indicating that methadone treatment (once a day for three consecutive days) increased embryolethality and neonatal mortality. Examination of uterine contents of methadone-naive female animals bred to methadone-treated male animals indicated that methadone treatment produced an increase in the rate of preimplantation deaths in all post-meiotic states. One study has suggested that gradual maternal dose reductions in methadone prior to delivery may be associated with decreased severity of neonatal withdrawal. Another study has reported that school age children exposed in utero to methadone may have lower IQ scores, greater anxiety, greater aggression and more behavioral problems than non-exposed children.

Methadone Breastfeeding Warnings

One study on mother/child pairs receiving medium to high oral dosing reported that the relative infant dose for R- plus S-methadone together was 2.8% (1.7% to 3.9%). Pregnant mothers using methadone should be counseled about the benefits and risks of breast-feeding while using methadone. Counseling should include the following information: 1) The baby receives a small amount of methadone through breast-milk. 2) The baby may experience methadone withdrawal if breast-feeding is discontinued suddenly. Patients discontinuing breast-feeding should develop a plan to wean with the baby's healthcare team. 3) Use of other substances of abuse during breast-feeding will expose the baby to additional risks. Patients who use other substances of abuse should not breast-feed. When starting methadone for the first time or increasing the dose, breast-feeding patients should watch their babies closely for changes in behavior or breathing patterns.

Methadone is excreted into and accumulates in human milk. Excreted methadone may prevent withdrawal symptoms in addicted infants. Methadone is considered compatible with breast-feeding by the American Academy of Pediatrics.

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