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9 Antipsychotics During Lactation
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aripiprazole (0.7–1.4%), olanzapine (1.0–1.8%), and nally risperidone (2.3–4.7%) suggesting minimal infant exposure through breast milk (Viguera etal. 2007b).
While these metrics provide valuable information, they should not be the sole basis for determining medication compatibility with breastfeeding. They function primarily as proxy measures and do not address the true clinical concern of whether the exposure correlates with any serious adverse effects in the infant (Verstegen etal. 2022; Hale’s Medications and Mothers’ Milk 2026). Other important factors, not captured in these metrics, that may make infants particularly vulnerable to seri­ous adverse reactions include prematurity, enhanced permeability of the blood-brain barrier, and compromised liver function (Payne 2021; Viguera et al. 2007b; Sadowski etal. 2013; Begg etal. 2002).
9.3.2 Medication Risk Category Classifications
Medication risk categorization systems such as the well-established Hale’s Lactation Risk Categories (Hale’s Medications and Mothers’ Milk 2026), provide a standard­ized framework for evaluating medication safety during breastfeeding based on pharmacokinetic parameters. Other recently published scoring systems consider additional non-pharmacokinetic parameters such as the number of exposed infants reported in the literature and prevalence of reported adverse events in calculating a safety score (Uguz 2021). These various category risk systems provide useful guid­ance and reduce complex information into a simplied rating score which is cer­tainly user-friendly for clinicians. However, they do not take into consideration other important individual variables which are essential for nuanced clinical deci­sion making—such as infant age and health condition, maternal illness severity, and risks of untreated condition—are not fully captured in these standardized frame­works. Furthermore, inconsistency between these different systems can create con­fusion, as the same medication may receive different risk categorizations depending on which framework is consulted. Given these constraints, clinicians should view these risk categories as merely one element within a more comprehensive decision­making framework rather than the sole determinant when advising breastfeeding mothers about medication use.

9.4 First-Generation Antipsychotics (FGAs)

First-generation antipsychotics (FGAs) are generally considered compatible with breastfeeding. Although most lactation safety data derive from case reports and observational studies published than controlled trials, the collective evidence dem­onstrate that these medications appear in minimal concentrations in breast milk and rarely cause adverse events in exposed infants (Klinger et al. 2013; Pacchiarotti etal. 2016; Larsen etal. 2015; Gentile 2008; McAllister-Williams etal. 2017).
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9.4.1 Haloperidol
Haloperidol is regarded as one of the safest antipsychotics to use during pregnancy (). While lactation safety data is more limited, Multiple reviews examining haloperi­dol secretion into breast milk and potential infant effects have concluded that halo­peridol is compatible with breastfeeding (). Evidence from observational studies—including several case reports and a prospective observational study—sug­gests no acute adverse effects in breastfed infants (Whalley etal. 1981; Mendhekar and Andrade 2011; Yoshida etal. 1998a). Only small amounts of haloperidol are excreted into breast milk ().
In one case report, a mother started on 10mg/day of haloperidol immediately after birth and discontinued therapy after 6weeks all while breastfeeding her infant (Whalley etal. 1981). The infant showed no signs of sedation and was feeding well. Follow-up assessments indicated normal development.
In another report, a mother took haloperidol (7.5–15mg/day) and trihexypheni­dyl during three pregnancies and throughout the postpartum periods (Mendhekar and Andrade 2011). She breastfed all three infants for 6–8months. All children met developmental milestones at the time of report (ages 16months to 8years).
In a small prospective study on the long-term effects of antipsychotics in breast­fed infants, a decline in developmental scores was found at 12–18months of age in 2 of 4 infants of mothers taking both haloperidol and chlorpromazine. The other 2 infants and all infants exposed to either drug alone developed normally (Yoshida etal. 1998a).
A breastfeeding mother with schizophrenia took risperidone (1.5mg) and later added haloperidol, which was increased from 0.8 to 1.5mg/day due to recurring symptoms. Three days after the increase, her infant experienced excessive sedation, poor feeding, and motor slowing, which resolved within 5 days after breastfeeding was discontinued, suggesting the drug combination was the cause (Uguz 2019).
9.4.2 Chlorpromazine
Multiple reviews of studies that examined the secretion of chlorpromazine into breast milk and potential adverse effects in infants have concluded that chlorproma­zine may be compatible with breastfeeding (Klinger etal. 2013; Pacchiarotti etal.
2016; Drugs and Lactation Database (LactMed®) 2006e). Excretion in breast milk
appears to be in small amounts (Yoshida etal. 1998a), with an estimated relative infant dose of 0.03–1.3% (Klinger etal. 2013; Odhejo etal. 2017). Older studies have noted drowsiness and placidity in infants (Yoshida et al. 1998b; Wiles etal. 1978).
In a study of four mother-infant pairs, chlorpromazine doses ranged from 50 to 600mg/day. While no acute negative effects were observed aside from possible drowsiness, developmental delays were noted in infants exposed to both chlorprom­azine and haloperidol (Yoshida etal. 1998b). In another study, two breastfed infants were observed: one exhibited drowsiness and lethargy, potentially linked to
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chlorpromazine, while the other showed no adverse effects. Breast milk chlorprom­azine concentrations were 92ng/mL in the affected infant’s mother and 7ng/mL in the unaffected infant’s mother (Wiles etal. 1978).
Seven infants were breastfed for 3–4months while their mothers took chlor­promazine (50–150mg daily at bedtime) (Kris and Carmichael 1957). Five of the infants were later evaluated at ages up to 4–5years, showing no noticeable issues with behavior, emotions, or mental health (Kris and Gross 1962). Thus, while levels in breast milk and adverse effects of exposure to chlorpromazine are low, close supervision with attention to drowsiness and development in the infant is recommended.
Other FGAs, such as triuoperazine and perphenazine, are compatible with breastfeeding (Klinger etal. 2013). Again, data are limited but suggest low levels of medication found in the breast milk and no acute adverse effects (Klinger etal. 2013).

9.5 Second-Generation Antipsychotics (SGAs)

Second-generation antipsychotics have increasingly become the preferred rst-line treatment in the treatment of mood, anxiety, and psychotics disorders compared to FGAs given a decreased risk of extrapyramidal side effects and their prolactin­sparing properties. Although evidence supporting the reproductive safety of these medications has expanded over the past two decades, data regarding their safety during lactation remains signicantly less robust and continues to evolve.
9.5.1 Olanzapine
Of the SGAs, olanzapine has been the most widely studied with respect to breast­feeding and is considered a reasonable choice for women who require a second­generation antipsychotic while nursing (Klinger etal. 2013; Pacchiarotti etal. 2016; Larsen et al. 2015; Uguz 2016). The bulk of the current evidence suggests that olanzapine is compatible with breastfeeding (Drugs and Lactation Database (LactMed®) 2006f, g). The reported relative infant dose of olanzapine ranges from
0.3% to 4% of the weight-adjusted maternal dose (Gardiner etal. 2003; Kirchheiner etal. 2000; Ambresin etal. 2004; Lutz etal. 2008; Croke etal. 2002).
Several observational studies provide evidence that olanzapine use during breast­feeding does not adversely affect infants. A review of 10 studies (total n=64 infants exposed to olanzapine) found that somnolence was observed in three infants (5%), slow weight gain in two (3%), and developmental delay in three (5%) (Klinger etal. 2013).
A prospective study found that adverse events were comparable for breastfeed­ing infants whose mothers were taking olanzapine (3/22 infants, 14%), non­breastfeeding infants of mothers taking olanzapine (1/15, 7%), and breastfeeding infants whose mothers were taking a drug known to be safe during lactation (4/51, 8%) (Gilad etal. 2011).
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A study examining the manufacturer’s safety registry, which included spontane­ously reported adverse events in mothers who used olanzapine during pregnancy and/or breastfeeding, found no adverse events were reported in 84/102 breastfed infants (82.3%). The most common adverse events associated with exposure were nonspecic, such as somnolence (4%), irritability (2%), tremor (2%), and insomnia (2%) (Brunner etal. 2013).
Several studies of serum assays of infants (total n=12) exposed to olanzapine via breast milk have not detected the drug (McAllister-Williams etal. 2017; Gilad etal. 2011). The mechanism may be due to low absorption and distribution of the drug in the large amounts of fat in children. However, one case report described an infant who had a serum concentration that was approximately 40 percent of the maternal level; subsequent infant serum concentrations were very low or undetect­able (Reis and Källén 2008).
9.5.2 Risperidone andPaliperidone
The evidence suggests that risperidone and its active metabolite, paliperidone, are com­patible with breastfeeding (Klinger etal. 2013; Pacchiarotti etal. 2016; Larsen etal.
2015; Uguz 2016; Risperidone 2006). The relative infant dose for risperidone ranges
from 2.3% to 9.1% of the weight-adjusted maternal dose (Klinger etal. 2013; Ilett etal.
2004). In three case report studies, infant serum assays (total n=4 infants) found that
risperidone and its active metabolite were only detected in one infant in which the metabolite was present at minimal concentrations (Ilett etal. 2004; Aichhorn etal. 2005; Weggelaar etal. 2011). Additionally, the reported M/P ratios were all below 0.5 (Ilett etal. 2004). In a separate study, concentration of the metabolite in breastmilk itself has also found to be low consistent with these ndings (Hill etal. 2000). Risperidone has been found to cause elevated prolactin serum levels (Bray and Karri 2022) However, high levels of prolactin alone may not affect a mother with established lactation’s ability to breastfeed (Risperidone 2006).
Two case studies (total n =3 infants) found no acute adverse effects occurred in breastfed infants (Ilett etal. 2004; Aichhorn etal. 2005). In mothers prescribed up to 6mg/day, no adverse effects have been reported in infants (Hill etal. 2000; Bray and Karri 2022). One study of two mothers on 4mg/day and 6mg/day while breastfeeding found no long-term developmental abnormalities of infants at 9months and 12months of age, respectively (Ratnayake and Libretto 2002) Another study of a mother on 1mg/ day found no physical or neurological abnormalities at 3months of age (Weggelaar etal. 2011).
In one recent study of a mother who started risperidone 1mg/daily on postpartum day 12 for psychiatric episodes, researchers concluded that her preterm infant’s two episodes of respiratory depression were likely caused by the drug (Pasi etal. 2023). A recent 26year follow-up of a woman who took 4–5mg/day of risperidone and 2mg/day of trihexyphenidyl while breastfeeding all ve of her children for 20–24months each, found that all children are or have done well academically and the oldest three com­pleted their education and were gainfully employed (Mendhekar and Andrade 2024).
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9.5.3 Quetiapine
Most studies suggest that quetiapine is compatible with breastfeeding (Klinger etal.
2013; Pacchiarotti etal. 2016; Larsen etal. 2015; Uguz 2016; Drugs and Lactation
Database (LactMed®) 2006a). Quetiapine demonstrates low excretion into breast milk (Drugs and Lactation Database (LactMed®) 2006a). Case series report that quetiapine was not secreted into breast milk at all at maternal daily doses <75mg, and for higher maternal doses, infant dose was calculated to be less than 0.01mg/kg (Misri etal. 2006; Aydin etal. 2015; Rampono etal. 2007). The reported relative infant dose ranges from 0.07% to 0.1%, which is extremely low (Klinger etal.
2013). Quetiapine has been found to have minimal effects on prolactin levels
(Maguire 2002).
One case report of a mother on 200mg/day of quetiapine for bipolar disorder reported no adverse effects in her breastfed infant (Uguz 2017). In another study, the infant of a mother taking 300mg/day during the last 3months of pregnancy and continuing post-partum was developing normally with no apparent adverse effects (Pastol etal. 2022). Several other studies report no adverse effects in breastfed infants of mothers taking quetiapine and other combinations of drugs including sodium valrpoate (Aydin et al. 2015), venlafaxine (Newport et al. 2009), and lamotrigine (Sharma and Sommerdyk 2016).
In the Misri etal. series of case reports, two infants of six were found to have mild developmental delays at age 12months, but the persistence of these ndings into later childhood remains unknown (Misri etal. 2006). In a prospective cohort study in India, two infants exposed to quetiapine in breastmilk had no short-term adverse events, however one who was also exposed in utero had motor and mental delays at 3months (Sinha etal. 2021).
9.5.4 Aripiprazole
Although denitive data regarding the use of aripiprazole during breastfeeding are limited to case reports, the available evidence is generally reassuring, showing mini­mal concentrations in breast milk with a relative infant dose estimated at 0.7–6.44% (Aripiprazole 2006; Nordeng etal. 2014; Lutz etal. 2010). Additionally, no signi­cant adverse effects have been observed in breastfed infants (Klinger etal. 2013; Pacchiarotti etal. 2016; Uguz 2016; Nordeng etal. 2014; Lutz etal. 2010; Cuomo etal. 2018; Watanabe etal. 2011).
The primary concern regarding aripiprazole during breastfeeding stems from multi­ple case reports linking it to inadequate milk production and premature lactation cessa­tion (Mantilla Reyes etal. 2020; Sahoo etal. 2023; Naughton etal. 2023; Yskes etal.
2018; Walker etal. 2019; Gentile 2014). Since aripiprazole functions as both a partial
dopamine agonist and antagonist, it can reduce serum prolactin levels in a dose-depen­dent manner, potentially leading to insufcient milk production by inhibiting prolactin release (Nordeng etal. 2014; Lutz etal. 2010). However, this effect is not consistently observed across all patients. Nevertheless, certain risk classication systems suggest
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that an alternate medication might be more appropriate (Uguz 2021; Aripiprazole 2006) or use with caution (Hale’s Medications and Mothers’ Milk 2026). In addition, available reports suggest no issues with infant growth and development in the short term (Nordeng etal. 2014; Lutz etal. 2010). A separate case report involving a mother using injectable aripiprazole while breastfeeding indicated normal developmental progression in her child through 3 years of age (Fernández-Abascal etal. 2021).
9.5.5 Clozapine
Clozapine stands out as the only antipsychotic generally contraindicated during breastfeeding due to the risk for agranulocytosis (Drugs and Lactation Database (LactMed®) 2006b). Although its RID is below 2%, its use would necessitate regu­lar monitoring of the infant with white blood cell counts and careful observation for sedation effects, creating practical barriers to its safe use during lactation (Klinger etal. 2013; Pacchiarotti etal. 2016; Larsen etal. 2015; Uguz 2016; Gentile 2008; McAllister-Williams etal. 2017; Payne 2021; Uguz 2021; Drugs and Lactation Database (LactMed®) 2006b).
If breastfeeding is undertaken by a mother who is taking clozapine, close moni­toring of the infant for hematologic effects (as is standard in adults taking clozap­ine) is highly recommended. Case reports suggest that clozapine tends to accumulate readily in breast milk in a dose-dependent manner (Barnas etal. 1994; Dev and Krupp 1995), however it does not appear to inuence maternal prolactin levels (Maguire 2002; Bergemann etal. 2005). The relative infant dose for clozapine is approximately 1.4% of the weight-adjusted maternal dose, but concerns about adverse effects remain signicant (Klinger etal. 2013).
A review of two observational studies (total n=5 infants exposed to clozapine) found that one baby suffered agranulocytosis, one baby manifested lethargy, and one had speech delay (Klinger et al. 2013). In a separate case study, an infant exposed during both pregnancy and breastfeeding through 1year of age had notice­able delay in speech acquisition though no other neurocognitive or motor decits were reported (Mendhekar 2007).
In a recent case report, a woman with schizophrenia breastfed during two pregnan­cies while taking clozapine (Uygur and Uygur 2019). No adverse effects were reported after the rst. During the second, under psychiatric care, she delivered while on clo­zapine 100mg daily, which was tapered as olanzapine was started and increased to 20mg daily. Due to ongoing hallucinations, clozapine was resumed at 50mg daily while breastfeeding continued. After a year of pediatric follow-up, no agranulocyto­sis, seizures, or neurodevelopmental issues were observed in the infant (Uygur and Uygur 2019).
Another case report described a woman with schizophrenia who took 75mg of clozapine daily during pregnancy and postpartum while breastfeeding (extent unspecied) (Uguz 2020). Her infant, monitored monthly with biweekly blood tests for 6 months, showed no hematologic or other adverse effects (Uguz 2020). However, these ndings are based on a very small sample size and limited recent data.
9 Antipsychotics During Lactation
The consensus in the medical literature recommends to avoid clozapine during breastfeeding (Klinger etal. 2013; Pacchiarotti etal. 2016; Larsen etal. 2015; Uguz
2016, 2021; Hale 2004; Gentile 2010; Drugs and Lactation Database (LactMed®) 2006b). Recently, lactation safety scoring systems developed have also categorized
the safety of clozapine as “very low” and therefore, not recommended with breast­feeding (Uguz 2021). However, if breastfeeding is undertaken, since clozapine has not been considered an absolute contraindication to breastfeeding, close monitoring of the infant is warranted (Uguz 2020).
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9.5.6 Amisulpride
Data on infant exposure to amisulpride via breastfeeding is lacking (Fortinguerra etal. 2009; Uguz 2016; Drugs and Lactation Database (LactMed®) 2006c) and excretion of amisulpride into breastmilk is higher than with other pharmacologi­cally similar drugs (Drugs and Lactation Database (LactMed®) 2006c). Two case reports show high transfer of amisulpride into breast milk with maternal dose of 200 mg/day and 400 mg/day, resulting in a relative infant dose of 6.7–10.7%, respectively (Ilett etal. 2010; Teoh etal. 2011).
These infants, however, experienced no side effects from amisulpride exposure and had normal development at follow-up. O’Halloran etal. (2016) assessed one mother-infant pair with amisulpride exposure in breast milk and found the concen­tration to be 12-fold higher than simultaneous serum concentration (O’Halloran et al. 2016). The infant plasma concentration was about 10.5% of the maternal plasma concentration. Given the lack of quality studies, amisulpride’s compatibility with breastfeeding remains largely unknown, and its use in breastfeeding should be evaluated on a case-by-case basis.
9.5.7 Ziprasidone
Data for ziprasidone during breastfeeding are very limited (Drugs and Lactation Database (LactMed®) 2006d). In one woman receiving a dose of 160mg/day postpar­tum, drug levels in milk were undetectable (Schlotterbeck etal. 2009). The milk-to­plasma ratio was estimated to be 0.06, with a relative infant dose estimated at 1.2% (Schlotterbeck etal. 2009). A separate case report found that infant exposure to ziprasi­done through breast milk resulted in no acute adverse effects, and the infant was healthy with normal growth and development at 6months of age (Werremeyer 2009).
9.5.8 Newer Second-Generation Antipsychotics
No substantial data are available on the use of asenapine (2006), brexpiprazole (2006), cariprazine (2006), iloperidone (2006), lumateperone (2006), or lurasidone (2006) during breastfeeding. However, insufcient data does not automatically imply that a medication is “unsafe” or incompatible with nursing.
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9.6 Comprehensive Risk-Benefit Assessment Framework

Clinical decision-making regarding antipsychotic use during breastfeeding requires careful consideration of multiple factors. An individualized assessment tailored to each mother-infant pair’s specic circumstances, including psychiatric history, medication response, and infant health status is recommended. Informed decision­making involves engaging mothers in the process with complete information about benets, as well as known and unknown risks. Throughout this process, the moth­er’s own preferences regarding breastfeeding should be considered as a critical component. An assessment framework is presented below:
9.6.1 Assessment ofMaternal Factors andInfant Factors
Maternal mental health must be prioritized, as untreated psychiatric illness poses greater risks to both mother and infant than medication exposure through breast milk (Miller etal. 2023). While breastfeeding offers important benets, delaying necessary psychiatric medications only to continue breastfeeding can have serious consequences including deteriorating mental health symptoms, prolonged periods without treatment, and negative effects on both maternal and infant well-being. Women who have remained stable on a psychotropic regimen during pregnancy should generally maintain their regimen postpartum, as changing medications solely for the purpose of breastfeeding is not recom­mended (Miller etal. 2023).
For patients who are initiating treatment with an antipsychotic during the postpartum period, medication selection should be guided by what has been effective in the past. If a medication is started de novo, the patient’s symptom­atology and severity of symptoms should guide medication selection. A family history of a good response to a particular medication may also help guide medi­cation choice.
The decision to breastfeed while taking medications is more complicated when a baby is premature or medically compromised (Nonacs etal. 2016; Llewellyn and Stowe 1998). The infant’s gestational age signicantly impacts medication metabo­lism, as premature infants have reduced metabolic capacity compared to full-term infants. Since most psychotropic medications are metabolized by the liver, there is lower capacity for hepatic drug metabolism (one-third to one-fth of adult capacity) during the rst few weeks of a full-term infant’s life (Verstegen etal. 2022; Begg etal. 2002; Kelsey 2016). This capacity increases dramatically over the rst few months, and by about 2–3months of age actually surpasses that of adults. In prema­ture infants or in infants with signs of compromised hepatic function (e.g., hyper­bilirubinemia), breastfeeding is typically deferred because these infants are less able to metabolize drugs and may be more susceptible to experience adverse events (Verstegen etal. 2022; Begg etal. 2002; Kelsey 2016).
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9.6.2 Review ofMedication Options
Although SGAs with most evidence for their safety in breastfeeding are generally preferred, when treatments with less evidence are medically necessary, breastfeed­ing should not be discontinued or discouraged. Rather, clinicians should work col­laboratively with patients by clearly discussing these uncertainties, honoring the patient’s informed decision, and continuing pregnancy medications if they have been effective (Miller etal. 2023). For example, olanzapine, quetiapine, and risperi­done have the most safety data during lactation and appear to be reasonable choices for breastfeeding women, while clozapine should generally be avoided. In addition, considering the medication’s potential impact on milk supply is important.
The “pumping and dumping” practice (temporarily expressing and discarding breast milk) was once advocated to reduce medication levels in breast milk. Currently, this approach is discouraged for women on psychotropic medications, including antipsychotics (Burkey and Holmes 2013). For medications at steady­state concentrations in maternal circulation, this strategy is ineffective since newly produced milk will contain comparable medication levels regardless of previous pumping (Burkey and Holmes 2013). Since this method does not accelerate medica­tion elimination from the mother’s system, it can create needless anxiety as mothers may obsess over synchronizing medication administration with their infant’s feed­ing routine. Instead, mothers should be reassured that the use of medications while breastfeeding rarely negatively impacts infants (Anderson etal. 2016).
9.6.3 Preserving Sleep andDeveloping Feeding Plan
Sleep disruption represents a critical concern for breastfeeding mothers with psy­chiatric conditions, particularly for those with bipolar disorder or psychotic disor­ders, where sleep deprivation can trigger relapse (Nonacs etal. 2016; Llewellyn and Stowe 1998).
Thus, when planning postpartum care, clinicians should assess the mother’s his­tory of sleep-related relapses, her sensitivity to sleep deprivation, availability of nighttime support, and feasibility of incorporating formula or expressed milk to share caregiving responsibilities. Exclusive breastfeeding, which requires mothers to perform all feedings or maintain regular pumping sessions, can create a challeng­ing cycle where sleep deprivation may worsen psychiatric symptoms, potentially compromising both maternal well-being and breastfeeding success. Partial breast­feeding with formula supplementation allows another caregiver to handle some or all-night feedings, enabling the mother to obtain longer periods of uninterrupted sleep. Using expressed breast milk allows partners or family members to assist with nighttime feedings. Some mothers and families may consider hiring a lactation nurse or doula to assist with nighttime feedings.
Many women often feel considerable societal pressure to breastfeed. For moth­ers with bipolar disorder or psychotic disorders, for whom sleep disruption is a particularly signicant trigger for relapse, prioritizing sleep protection is essential