The American Academy of Pediatrics places emphasis on increasing breastfeeding in the United States. A common reason for the cessation of breastfeeding is the use of medication by the nursing mother and advice by her physician to stop nursing. Such advice may not be warranted. This statement is intended to supply the pediatrician, obstetrician, and family physician with data, if known, concerning the excretion of drugs into human milk. Most drugs likely to be prescribed to the nursing mother should have no effect on milk supply or on infant well-being. This information is important not only to protect nursing infants from untoward effects of maternal medication but also to allow effective pharmacologic treatment of breastfeeding mothers. Nicotine, psychotropic drugs, and silicone implants are 3 important topics reviewed in this statement.

Transfer of drugs and other chemicals into human milk

Objective : Given concerns about use of psychotropic medication during pregnancy, the authors reviewed the literature regarding the effects of prenatal exposure to psychotropic medications on fetal outcome. Method : A MEDLINE search of all articles written in English from 1966 to 1995 was performed to review information on the effects of psychotropic drug use during pregnancy on fetal outcome. Where sufficient data were available and when methodologically appropriate, meta-analyses were performed to assess risk of fetal exposure by psychotropic medication class. Results : Three primary effects are associated with medication use during pregnancy : 1) teratogenicity, 2) perinatal syndromes (neonatal toxicity), and 3) postnatal behavioral sequelae. For many drug classes there are substantial data regarding risk for teratogenicity. Tricyclic antidepressants do not seem to confer increased risk for organ dysgenesis. The available data indicate that first-trimester exposure to low-potency phenothiazines, lithium, certain anticonvulsants, and benzodiazepines may increase the relative risk for congenital anomalies. However, the absolute risk of congenital malformations following prenatal exposure to most psychotropics is low. Conclusions : Exposure to certain psychotropic drugs in utero may increase the risk for some specific congenital anomalies, but the rate of occurrence of these anomalies even with the increased risk remains low. Use of psychotropic medications during pregnancy is appropriate in many clinical situations and should include thoughtful weighing of risk of prenatal exposure versus risk of relapse following drug discontinuation. The authors present disorder-based guidelines for psychotropic drug use during pregnancy and for psychiatrically ill women who wish to conceive.

Pharmacologic management of psychiatric illness during pregnancy: Dilemmas and guidelines

To the Editor.— I read with interest the Committee on Drugs second report about transfer of drugs and other chemicals into human milk.1 Although the objective to categorize those drugs with reported harmful, or not, effects on children has been achieved with admirable brevity, the report fails to cite two useful areas of information. The WHO Task Force on Drugs in Human Milk reviewed the world literature and compiled a recently published book entitled Drugs and Human Lactation.2

Transfer of Drugs and Other Chemicals into Human Milk

OBJECTIVE: This study evaluated the effects of prenatal antidepressant exposure on perinatal outcomes, congenital malformations, and early growth and development. METHOD: Within a group-model health maintenance organization, all infants with apparent prenatal exposure to tricyclic or selective serotonin reuptake inhibitor (SSRI) antidepressants were frequency matched to an unexposed comparison group by year of birth, maternal age, and mother’s lifetime use of antidepressant drugs and mental health care. A structured blind review of mothers’ and infants’ medical records examined perinatal outcomes, congenital malformations, and developmental delay. RESULTS: Tricyclic antidepressant exposure was not associated with any significant difference in perinatal outcomes. Exposure to SSRIs was associated with a 0.9-week decrease in mean gestational age, a 175-g decrease in mean birth weight, and a 0.29 decrease in mean Apgar score at 5 minutes, but differences in birth weights and Apgar scores were not significant ...

https://ajp.psychiatryonline.org/doi/pdfplus/10.1176/appi.ajp.159.12.2055

Outcomes of Prenatal Antidepressant Exposure

Many mothers are inappropriately advised to discontinue breastfeeding or avoid taking essential medications because of fears of adverse effects on their infants. This cautious approach may be unnecessary in many cases, because only a small proportion of medications are contraindicated in breastfeeding mothers or associated with adverse effects on their infants. Information to inform physicians about the extent of excretion for a particular drug into human milk is needed but may not be available. Previous statements on this topic from the American Academy of Pediatrics provided physicians with data concerning the known excretion of specific medications into breast milk. More current and comprehensive information is now available on the Internet, as well as an application for mobile devices, at LactMed (http://toxnet.nlm.nih.gov). Therefore, with the exception of radioactive compounds requiring temporary cessation of breastfeeding, the reader will be referred to LactMed to obtain the most current data on an individual medication. This report discusses several topics of interest surrounding lactation, such as the use of psychotropic therapies, drugs to treat substance abuse, narcotics, galactagogues, and herbal products, as well as immunization of breastfeeding women. A discussion regarding the global implications of maternal medications and lactation in the developing world is beyond the scope of this report. The World Health Organization offers several programs and resources that address the importance of breastfeeding (see http://www.who.int/topics/breastfeeding/en/).

/pdf/the-transfer-of-drugs-and-therapeutics-into-human-breast-47la9mzf3r.pdf

The Transfer of Drugs and Therapeutics Into Human Breast Milk: An Update on Selected Topics

Clomipramine is a chlorinated tricyclic antidepressant commonly used in the treatment of depression (1). The drug is widely prescribed in Europe and Canada and has been recently approved for use in the USA. Its safety during pregnancy and breastfeeding, however, has not been fully established. Very few reports on its effect on the fetus and neonate have been published (2,3). We report a case of a mother treated with clomipramine during pregnancy, and the side effects observed in the infant. The correlation between plasma clomipramine concentrations in the baby's blood and clinical effects are described. Subsequently, we present the pregnancy outcome of five prospectively collected cases.

Yechezkel Shaag

Papers

Toxic Neonatal Effects Following Maternal Clomipramine Therapy