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Baclofen use while Breastfeeding

Drugs containing Baclofen: Lioresal, Gablofen, Kemstro, FBL Kit, Lioresal Intrathecal

Baclofen Levels and Effects while Breastfeeding

Summary of Use during Lactation

Limited information indicates that baclofen appears in low levels in milk and would not be expected to cause any adverse effects in breastfed infants, especially if the infant is older than 2 months. Monitor newborn infants for signs of sedation. Low intrathecal doses and topical application are unlikely to affect the nursing infant.

Drug Levels

Maternal Levels. A woman with spastic paraplegia was given a single oral 20 mg dose of baclofen 14 days postpartum. A peak milk level of about 0.13 mg/L occurred 4 hours after the dose. The half-life in milk was 5.6 hours. The authors estimated that the total amount recovered in breastmilk over 26 hours was 22 mcg.[1]

A woman with spinal cord injury was taking baclofen 20 mg four times at evenly spaced intervals between 0600 and 2200 daily during pregnancy and postpartum. Breast milk samples were collected at estimated trough (0530) and peak (2400) times on 3 consecutive days postpartum. Trough levels averaged 0.297 mg/L (range 0.28 to 0.32 mg/L). Peak levels averaged 0.343 mg/L (range 0.32 to 0.38 mg/L).[2] Using the average of the peaks and troughs, a fully breastfed infant would receive a daily dosage of 0.048 mg/kg, which would be 3.6% of the maternal weight adjusted dosage.

Infant Levels. Relevant published information was not found as of the revision date.

Effects in Breastfed Infants

An infant was born after exposure to baclofen in utero. The mother was taking baclofen 10 mg twice daily plus clonazepam 1 mg orally twice daily and sustained-release oxycodone 50 mg daily in divided doses. The infant was breast and bottle fed while the mother continued taking baclofen. Neonatal withdrawal symptoms necessitated phenobarbital administration. The infant also received baclofen 0.5 mg/kg daily in 4 divided doses that was weaned and decreased by day 9 of life. Neurologic examination was normal at discharge on day 16 and at 6-weeks of age.[3]

A woman with spinal cord injury was taking baclofen 20 mg four daily during pregnancy and postpartum. After birth, the infant received about 1/3 of the diet as breastmilk containing baclofen plus an initial baclofen dosage of 0.1 mg/kg/day for 4 days, followed by a daily decrease of 0.01 mg/kg/day until discontinuation of the baclofen on the 13th day of life. Daily assessment for neonatal abstinence syndrome (NAS) was performed using the modified Finnegan NAS scoring system. Of 82 modified Finnegan NAS scores obtained in the first 16 days of life, the mean score was 2. The maximum NAS score of 9 was observed on the 13th day of life. At no point were there three consecutive NAS scores of 8 or greater, indicating no need for further pharmacological intervention. The infant was discharged 3 days after the taper ended.[4]

Effects on Lactation and Breastmilk

Relevant published information was not found as of the revision date.

References

1. Eriksson G, Swahn CG. Concentration of baclofen in serum and breast milk from a lactating woman. Scand J Clin Lab Invest. 1981;41:185-7. PMID: 7313501

2. Lin HH, Barton N, Wiegand TJ. Baclofen distribution into breast milk-a potential for toxicity? J Med Toxicol. 2014;10:86. Abstract. DOI: doi:10.1007/s13181-013-0376-x

3. Moran LR, Almeida PG, Worden S et al. Intrauterine baclofen exposure: a multidisciplinary approach. Pediatrics. 2004;114:e267-9. PMID: 15286268

4. Lin HH, Barton N, Wiegand TJ. Prevention of neonatal abstinence syndrome in the setting of intrauterine baclofen exposure. J Med Toxicol. 2014;10:85-6. Abstract. DOI: doi:10.1007/s13181-013-0376-x

Baclofen Identification

Substance Name

Baclofen

CAS Registry Number

1134-47-0

Drug Class

GABA Agonists

Muscle Relaxants, Central

Administrative Information

LactMed Record Number

337

Last Revision Date

20160401

Disclaimer

Information presented in this database is not meant as a substitute for professional judgment. You should consult your healthcare provider for breastfeeding advice related to your particular situation. The U.S. government does not warrant or assume any liability or responsibility for the accuracy or completeness of the information on this Site.

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