Psychotropic Drug Use During Breastfeeding

Psychotropic Drug Use During Breastfeeding: A Review of the Evidence
Pediatrics 2009;124;e547-e556; originally published online Sep 7, 2009;
Filomena Fortinguerra, Antonio Clavenna and Maurizio Bonati
DOI: 10.1542/peds.2009-0326

OBJECTIVE: The objective of this study was to review the existing literature on the use of various classes of psychotropic medications during breastfeeding to provide information about infant exposure levels and reported adverse events in breastfed infants.
METHODS: A bibliographic search in the Medline (1967 through July 2008), Embase (1975 through July 2008), and PsycINFO (1967 through July 2008) databases was conducted for studies on breastfeeding and psychotropic medications for a total of 96 drugs. References of retrieved articles, reference books, and dedicated Web sites were also checked. The manufacturers were contacted for drugs without published information. Original articles and review articles that provide pharmacokinetic data on drug excretion in breast milk and infant safety data were considered, to estimate the “compatibility level” of each drug with breastfeeding.
RESULTS: A total of 183 original articles were eligible for analysis. Documentation was retrieved for 62 (65%) drugs. In all, 19 (31%) psychotropic drugs can be used during lactation according to an evidence based approach. For 28 drugs, the available data do not permit an evaluation of the drug’s safety profile during breastfeeding and, for an additional 15 drugs, the exposure dose or observed adverse effects make their use unsafe.
CONCLUSIONS: Although most drugs are considered safe during breastfeeding, compatibility with breastfeeding has not been established for all psychotropic drugs. There is a need for additional research and accumulation of experience to guarantee a more rational use of psychotropic drugs during breastfeeding. Pediatrics 2009;124:
e547–e556
AUTHORS: Filomena Fortinguerra, PharmD, Antonio Clavenna, MD, and Maurizio Bonati, MD
Laboratory for Mother and Child Health, Public Health Department, Mario Negri Institute for Pharmacological
Research, Milan, Italy


I love the way this article begins with this statement, “Breastfeeding is essential for the physical and psychological health of both mother and child, and its benefits are well documented.”

And then the comment that, “Despite the increased attention toward breastfeeding, however, information on breast milk drug excretion and knowledge of the adverse effects on the infant are often unavailable or still limited for many drugs that frequently are used by women of childbearing age, and misinformation abounds.” But the truth is it is not profitable for most pharmaceutical companies to research the small population of women breastfeeding to determine if a drug has an interaction with their baby’s breastmilk. It is easier to just determine that it is not okay for a mom to take most medications than to do the tests.

The article then makes this statement, “Worldwide, more than half of breastfeeding women take some type of drug and the concern about potential harm to the nursing infant from maternal medications is often cited as a reason to stop lactation,11 even if discontinuing breastfeeding is often the wrong decision. The Summary of Product Characteristics should not be considered a reliable source of breastfeeding information; it often indicates that a drug is not recommended during lactation, suggesting that it be avoided or that breastfeeding be interrupted. The warnings are not necessarily related to observed or reported adverse effects; they are often used as a defensive measure on the part of the manufacturer when the drug’s safety information is not available.”

What is astounding is how many women who could benefit from drugs are not getting them or not taking them or weaning their babies unnecessarily since no one is doing any real studies on drugs that could be helpful to them.

“It has been estimated that, each year, more than 500 000 pregnancies in the United States are complicated by psychiatric disorders such as depression, anxiety, and psychosis, which often develop, recur, and/or worsen during and after pregnancy. Furthermore, 13% of all psychiatric hospital admissions for women occur during the first postpartum year. Depression is the most frequent mental disorder in the perinatal period: 10% to 16% of pregnant women fulfill diagnostic criteria for major or minor depression, but up to 70% report symptoms of depression. Furthermore, 7% to 20% of women receive a diagnosis of postpartum depression in the first year after delivery. Untreated depression and anxiety can have a negative impact on pregnancy, and adverse short-term and long-term effects can have a negative impact on the developing infant and child.”

This article sited several studies to determine what is really known out there regarding drug interactions with breastfeeding infants from psychotropic drugs that their mothers were taking. They looked at several methods of determining how safe the drugs were- from dosage- to length of time the drugs were taken- to amount found in breastmilk to effect on babies in adverse ways. They looked at what may be compatible, what needed to be used very cautionary and what was contraindicated.

“A total of 19 (31%) psychotropic drugs can be used during lactation according to an evidence-based approach, whereas for 28 drugs, the available data do not allow an evaluation of their safety profile during breastfeeding.”

Antidepressants had been studied most. “In particular, among the antidepressants, sertraline, paroxetine, and fluvoxamine are the first-choice drugs for treatment of depression in breastfeeding mothers because they have the lowest degree of excretion into human breast milk.” “Antipsychotics are the class with the smallest number of studies concerning use during breastfeeding. The available data regarding the use of hypnotic and anxiolytic agents during breastfeeding are scant.”

I found it interesting that, “there have been no studies on infants’ long-term exposure to very low dosages of antidepressants.” It is as if the studies allows the mother to go on the drug but does not care once they determine it is okay what the long term effect on the infant could possibly be. Looking at long term effects seem the most important as that is what will cause the longer lasting issues.

The article stated, “The decision to prescribe psychotropic agents to breastfeeding mothers should depend on an individual risk/benefit analysis: the known benefits of breastfeeding and medication use for both mother and infant must be weighed against the risk of untreated maternal illness or the risk of infant exposure to medications through breast milk.”

But since so often physicians would rather just have the mom wean the baby and treat their patient without regard to the individual desires and needs of the nursing dyad, many moms wean unnecessarily. Or a mother who needs treatment will forgo the treatment at risk to herself and possibly her infant.

The conclusion of these authors was that more studies need to be done and the safety issue of many of these drugs is still unknown and quite controversial. So, this was their call to action report of sorts.

I attended a dinner that Dr Zachary Stowe, a renowned physician (Professor, Psychiatry & Behavioral Sciences Director, Women’s Mental Health Program Emory University School of Medicine in Atlanta, Georgia) presented information about psychotropic drugs and breastfeeding moms. He gave several ways to help a mom avoid depression, which included simple things like receiving postpartum help, going for walks outside in the sunshine and many others. But he stated that it is important in order to have a happy baby to have a happy mom. Getting moms the medication they need without unnecessarily weaning a baby is imperative. We know the benefits of breastfeeding on the baby and we need to stop throwing the proverbial baby out with the bath water. Research needs to be done more fervently and more physicians need to try to keep the baby and mother nursing dyad together. Mental illness needs to be treated like so many other diseases and illnesses- with avid research in order to be treated without putting the baby at risk- and that includes weaning the baby when we know the health benefits of nursing that are well documented.

Teresa Howard