Estimation of Atenolol Transfer Into Milk and Infant Exposure During Its Use in Lactating Women

Lwin, Ei Mon Phyo; Gerber, Jacobus P.; Leggett, Catherine; Song, Yunmei; Ritchie, Usha; Turner, Sean; Hague, William; Upton, Richard N.; Garg, Sanjay

doi:10.1177/0890334418771308

Cited by 7 publications

(6 citation statements)

References 12 publications

(35 reference statements)

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“…The methods for the collection and analysis of human milk and plasma samples were consistent with those described in our previous research (Leggett et al, 2020; Lwin, Gerber, et al, 2018; Lwin, Leggett, et al, 2018). During the study period, the participant took modafinil 300 mg at 9 a.m. and 100 mg at 12:30 p.m. on Day 1, and 300 mg at 9:30 a.m. and 100 mg at 1 p.m. on Day 2.…”

Section: Managementmentioning

confidence: 82%

Infant Exposure to Armodafinil Through Human Milk Following Maternal Use of Modafinil

et al. 2022

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Introduction Narcolepsy, a condition adversely affecting psychological, social, and cognitive function, is more prevalent in females of childbearing age than the general population. Modafinil and armodafinil are central nervous system stimulants approved for treatment of narcolepsy. Infant exposure to these agents through human milk has not been investigated. Poor quality medication safety information during lactation is associated with early cessation of breastfeeding and suboptimal healthcare for the breastfeeding family. Main Issue In this case study, we measured the concentration of armodafinil (the most active form of modafinil) in human milk and infant plasma to quantify infant exposure. Management The participant was a 30-year-old primipara with narcolepsy, taking modafinil (300 mg morning, 100 mg noon) while breastfeeding her 6-week-old infant despite the paucity of safety information. Armodafinil concentrations were measured in eight serial human milk samples collected over a 26-hr period and in single maternal and infant plasma samples using ultra performance liquid chromatography - tandem mass spectrometry. The average concentration of armodafinil in human milk was 1.96 mg/L; the relative infant dose was 4.85%; the theoretical infant dose was 0.294 mg/kg/day. Maternal and infant plasma concentrations of armodafinil were 12.02 mg/L and 0.19 mg/L, respectively. The participant continued to exclusively breastfeed the infant, who had normal growth and development. Conclusion Based on these findings, relatively small amounts of armodafinil pass into human milk, with consequent limited infant exposure. Consideration can be given to the use of modafinil or armodafinil during breastfeeding, provided the infant is monitored. Further studies are needed to confirm these findings.

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Section: Managementmentioning

confidence: 82%

Infant Exposure to Armodafinil Through Human Milk Following Maternal Use of Modafinil

et al. 2022

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“…However, the degree of excretion of different beta-blockers into breast milk is dependent on their individual pharmacokinetic characteristics [ 7 ]. Beta-blockers such as labetalol and propranolol pass into breastmilk in low concentrations [ 8 , 9 ], while atenolol reaches a relatively higher breastmilk concentration [ 10 ]. The question arises as to whether beta-blocker exposure is safe for the neonate.…”

Section: Introductionmentioning

confidence: 99%

The Risk for Neonatal Hypoglycemia and Bradycardia after Beta-Blocker Use during Pregnancy or Lactation: A Systematic Review and Meta-Analysis

Bruin

Dalen

Franx

et al. 2022

IJERPH

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Beta-blockers are often used during pregnancy to treat cardiovascular diseases. The described neonatal side effects of maternal beta-blocker use are hypoglycemia and bradycardia, but the evidence base for these is yet to be evaluated comprehensively. Hence, this systematic review and meta-analysis was performed to evaluate the potential increased risk for hypoglycemia and bradycardia in neonates exposed to beta-blockers in utero or during lactation. A systematic search of English-language human studies was conducted until 21 April 2021. Both observational studies and randomized controlled trials investigating hypoglycemia and/or bradycardia in neonates following beta-blocker exposure during pregnancy and lactation were included. All articles were screened by two authors independently and eligible studies were included. Pair-wise and proportion-based meta-analysis was conducted and the certainty of evidence (CoE) was performed by standard methodologies. Of the 1.043 screened articles, 55 were included in this systematic review. Our meta-analysis showed a probable risk of hypoglycemia (CoE—Moderate) and possible risk of bradycardia (CoE—Low) in neonates upon fetal beta-blocker exposure. Therefore, we suggest the monitoring of glucose levels in exposed neonates until 24 h after birth. Due to the limited clinical implication, monitoring of the heart rate could be considered for 24 h. We call for future studies to substantiate our findings.

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“… 3 Beta-blockers such as labetalol and propranolol can pass into the breastmilk in low concentrations, 4 5 while beta-blockers such as atenolol and sotalol reach relatively high concentrations. 6 7 …”

Section: Introductionmentioning

confidence: 99%

“…In addition, some beta-blockers have been found in breast milk, although the degree of excretion into breast milk of different beta-blockers is dependent on their individual pharmacokinetic parameters 3. Beta-blockers such as labetalol and propranolol can pass into the breastmilk in low concentrations,4 5 while beta-blockers such as atenolol and sotalol reach relatively high concentrations 6 7…”

Section: Introductionmentioning

confidence: 99%

Risk for neonatal hypoglycaemia and bradycardia after beta-blocker use during pregnancy or lactation: a systematic review and meta-analysis protocol

et al. 2022

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IntroductionBeta-blockers are often used during pregnancy to treat diseases such as pre-existing hypertension, arrhythmias or pregnancy-related hypertension. Since beta-blockers are able to cross the placenta and can pass into breast milk, they could potentially harm the neonate. Known potential neonatal side effects of maternal beta-blocker use are hypoglycaemia and bradycardia. This systematic review and meta-analysis aims to investigate the risk for neonatal hypoglycaemia and bradycardia after exposure to beta-blockers in utero or through lactation.Methods and analysisWe will conduct a systematic review according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. A systematic electronic search will be conducted using EMBASE, Medline, Cochrane Central Register of Trials and Web of Science from initiation to April 2021. Our primary outcome will be the risk for hypoglycaemia or bradycardia in neonates exposed to beta-blockers in utero or through lactation in comparison with unexposed neonates. All articles will be screened by title and abstract twice by different independent review authors. Next, standardised methodological quality assessment will be conducted for each included article and finally a meta-analysis will be performed.Ethics and disseminationEthical approval is not required. The results of this study will help to assess the need for postnatal glucose and heart rate monitoring of the neonate after maternal beta-blocker exposure. Our findings will be communicated to the target audience through peer-reviewed publication.PROSPERO registration numberCRD42021264269.

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Estimation of Atenolol Transfer Into Milk and Infant Exposure During Its Use in Lactating Women

Abstract: Atenolol use during breastfeeding should be undertaken with some precaution. If clinically indicated, an alternate beta blocker may be preferred.

Cited by 7 publications

References 12 publications

Infant Exposure to Armodafinil Through Human Milk Following Maternal Use of Modafinil

Infant Exposure to Armodafinil Through Human Milk Following Maternal Use of Modafinil

The Risk for Neonatal Hypoglycemia and Bradycardia after Beta-Blocker Use during Pregnancy or Lactation: A Systematic Review and Meta-Analysis

Risk for neonatal hypoglycaemia and bradycardia after beta-blocker use during pregnancy or lactation: a systematic review and meta-analysis protocol

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