Neonatology pp 677-691 | Cite as

Safety of Medications During Pregnancy and Breastfeeding: Infants of Drug-Addicted Mothers

  • Karel AllegaertEmail author
  • Tim van Mieghem
  • John N. van den Anker
Reference work entry


Any decision on maternal pharmacotherapy should be balanced, comparing maternal and fetal/neonatal outcome to withholding any treatment. This is because there is a relevant body of evidence that uncontrolled maternal conditions also affect fetal outcome. The same holds true for breastfeeding.

Drugs are not thoroughly evaluated for use during pregnancy or breastfeeding. Knowledge on safety of drugs exposure during fetal and neonatal (breastfeeding) life is limited. Pregnancy category classifications for drugs are currently used, but have their limitations. Pregnancy exposure registries to build knowledge have been implemented in the recently revised version of the FDA labelling guidelines (Pregnancy and Lactation Labeling Final Rule).

Suggestive indicators of “likely safe during breastfeeding” are (i) drugs commonly administered to infants, (ii) drugs that are not absorbed following oral administration, (iii) not excreted into human milk, and finally (iv) drug considered safe during pregnancy, since fetal exposure is generally longer and more extensive. Aspects of opioids, benzodiazepines, and anti-epileptics use during fetal life or via breastfeeding have been discussed to illustrate the concepts of pregnancy-related clinical pharmacology, followed by a focused discussion on neonatal abstinence syndromes. We hereby aim to provide the practicing clinician with some guidance and sources of information.


Antiepileptic drugs Benzodiazepines Breastfeeding Drug labeling LactMed Maternal–fetal pharmacotherapy Motherisk program Neonatal abstinence syndrome (NAS) Neonatal withdrawal syndromes Selective serotonin reuptake inhibitors (SSRIs) 



Karel Allegaert is supported by the Fund for Scientific Research, Flanders (fundamental clinical investigatorship 1800214 N), and the research activities are further facilitated by the agency for innovation by Science and Technology in Flanders (IWT) through the SAFEPEDRUG project (IWT/SBO 130033). John van den Anker is supported by NIH (K24DA027992, R01HD048689, U54HD071601) and the European Commission (TINN [223614], TINN2 [260908]. NEUROSIS [223060]).


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Copyright information

© Springer International Publishing AG, part of Springer Nature 2018

Authors and Affiliations

  • Karel Allegaert
    • 1
    • 2
    • 6
    Email author
  • Tim van Mieghem
    • 2
    • 3
  • John N. van den Anker
    • 4
    • 5
    • 6
  1. 1.Neonatal Intensive Care UnitUniversity Hospitals LeuvenLeuvenBelgium
  2. 2.Department of Development and RegenerationKU LeuvenLeuvenBelgium
  3. 3.Obstetrics and GynecologyUniversity Hospitals LeuvenLeuvenBelgium
  4. 4.Division of Pediatric Clinical PharmacologyChildren’s National Health SystemWashingtonUSA
  5. 5.Departments of Pediatrics, Integrative Systems Biology, Pharmacology and PhysiologyGeorge Washington University, School of Medicine and Health SciencesWashingtonUSA
  6. 6.Intensive Care and Department of Pediatric SurgeryErasmus MC – Sophia Children’s HospitalRotterdamThe Netherlands

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