Background: The impact of COVID-19 vaccination on breastfeeding is unknown. The primary aim of this study was to determine whether vaccine-related side effects following COVID-19 vaccination were associated with an adverse impact on breastfeeding. Secondarily, we sought to determine perceived symptoms in breastfed children and maternal opinion about COVID-19 vaccination. Materials and Methods: We conducted a cross-sectional survey of breastfeeding mothers who underwent COVID-19 vaccination >2 days before the survey. Subjects were recruited through social media and websites. Data included sociodemographic information, vaccine history, maternal and child symptoms, and impact on lactation/breastfeeding. Bivariate statistics (chi-square, Wilcoxon rank sum, and t tests) and multivariable logistic regression models examined the association of vaccine side effects with lactation, symptoms in breastfed children, and maternal opinion on vaccination. Results: Analysis included 4,455 breastfeeding mothers. Maternal postvaccination symptoms were more common after the second dose (p < 0.001). Overall, 77 (1.7%) respondents reported a negative impact on breastfeeding postvaccination, and these mothers were more likely to have experienced fatigue, headache, muscle pain, injection site pain, chills, fever, or allergic reactions. After adjusting for confounding variables, higher odds of an adverse impact on lactation were associated with lower breastfeeding intensity, dose of vaccine, and child symptoms. Even among mothers who reported an adverse impact on breastfeeding, maternal opinion about vaccination and confidence in their decision to receive the COVID-19 vaccine were high. Conclusions: COVID-19 vaccination among breastfeeding mothers resulted in minimal disruption of lactation or adverse impact on the breastfed child. These findings may be considered in vaccination decision-making.

Postpartum mothers and their healthcare providers often face the challenge of limited data regarding the safety of drug therapies during lactation. Pregnancy can lead to sustained weight gain, and obesity can negatively impact both physical and psychological well-being. The introduction of GLP-1 agonists to augment weight loss has become a topic of interest for many postpartum mothers. Our study aims to investigate the transmission of semaglutide into human milk in the first steps to ensure the safety and health of both lactating mothers and their breastfed infants. Semaglutide quantification was performed using high-resolution liquid chromatography-mass spectrometry. InfantRisk Center Human Milk biorepository released milk samples from eight women collected at 0, 12 and 24 h post-semaglutide administration. Semaglutide was extracted using protein precipitation in methanol, followed by chromatographic separation. Linear calibration curves for the method ranged between 2.5–30 ng/mL, with a limit of detection of 1.7 ng/mL and a limit of quantification of 5.7 ng/mL (LLOQ). Semaglutide was not detected in any of the collected human milk samples. A worst-case scenario of the relative infant dose (RID) was calculated using the LLOQ as the drug concentration in milk when considering semaglutide’s bioavailability and long-acting dose profile. The maximum RID projected was 1.26%, far below the standard 10% safety threshold. While questions about long-term infant outcomes, the safety of maternal nutrient intake, and the nutrient content of breast milk remain, our findings suggest that semaglutide concentrations in human milk are unlikely to pose clinical concerns for breastfed infants. These results support healthcare providers in making informed decisions regarding postpartum therapeutic interventions.

Background: Peripartum cardiomyopathy (PPCM) is a common cause of heart failure (HF) in the peripartum. Some medications are considered safe while breastfeeding. However, sacubitril/valsartan (Entresto), while efficacious, is not recommended in breastfeeding women due to concerns about adverse infant development, and no published data suggest otherwise.Objectives: This study aimed to assess the transfer of sacubitril/valsartan into human milk and evaluate the infant’s risk of drug exposure.Methods: The InfantRisk Human Milk Biorepository released samples and corresponding health information from five breastfeeding maternal–infant dyads exposed to sacubitril/valsartan. Sacubitril, valsartan, and LBQ657 (sacubitril active metabolite) concentrations were determined using liquid chromatography-mass spectrometry (LC/MS/MS) from timed samples 0, 1, 2, 4, 6, 8, 10, and 12 h following medication administration at steady state conditions.Results: Valsartan levels were below the detection limit of 0.19 ng/mL in all milk samples. Sacubitril was measurable in all milk samples of the five participants, peaking 1 h after drug administration at a mean concentration of 1.52 ng/mL for a total infant dose of 0.00049 mg/kg/12 h and a relative infant dose (RID) calculated at 0.01%. The maximum concentration of its active metabolite LBQ657 in the milk samples was observed 4 h after medication administration and declined over the remaining 12-h dosing interval, for an average concentration of 9.5 ng/mL. The total infant dose was 0.00071 mg/kg/12 h, and the RID was 0.22%. Two mothers reported continuing to breastfeed while taking sacubitril/valsartan; both mothers stated observing no negative effects in their breastfed infants.Conclusion: The transfer of sacubitril/valsartan into human milk is minimal. These concentrations are unlikely to pose a significant risk to breastfeeding infants, with a combined calculated RID of <0.25%, which is far lower than the industry safety standards (RID <10%).

Background: Domperidone is a dopamine-2 antagonist used off-label to increase breast milk production. Dosages commonly promoted for lactation are often far above those of studied on-label indications and might pose additional risks, especially upon discontinuation of the drug. Patients: Three U.S. patients are presented who used domperidone for lactation and experienced varying degrees of psychiatric withdrawal symptoms lasting months during dosage tapering and after cessation. Conclusion: Domperidone as a galactagogue may pose a significant psychiatric risk upon discontinuation. This presentation is commonly confused with, but clinically distinct from, postpartum depression. Lactating mothers who present with psychiatric symptoms should be explicitly probed about domperidone use, even in areas where domperidone is not authorized for use. Maternal hesitancy to disclose domperidone use may lead to suboptimal outcomes for the patient and delay management of withdrawal manifestations. The best course of treatment remains unknown, but a slow hyperbolic taper to gently discontinue domperidone may minimize withdrawal symptoms in these patients. Individuals exploring domperidone use should be informed of potential risks upon withdrawal, including psychiatric manifestations, requisite taper, and potential impacts of using unstudied high doses.

Background: Statins are historically contraindicated during breastfeeding due to theoretical concerns of disruptions in infant development from drug exposure and nutritional changes in milk. Breastfeeding mothers requiring statins often discontinue statins or postpone treatment until breastfeeding cessation, contributing to delays in treatment up to 14 years. This study aims to determine the transfer of atorvastatin and its active metabolites into human milk and evaluate the infant’s risk of drug exposure. Materials and Methods: Milk samples and health information were released from the InfantRisk Human Milk Biorepository for three women taking 20 mg, 40 mg, and 80 mg of atorvastatin daily at steady state conditions. The concentration of atorvastatin (AT) and its active metabolites, ortho-hydroxy AT (2OH AT) and para-hydroxy AT (4OH AT), was quantified in timed milk samples using liquid chromatography–mass spectrometry. Results: The highest absolute infant dose of AT was 0.00027 mg/kg/day, and the highest weight-adjusted relative infant dose of the combined analytes was 0.09%, far below established thresholds for infant safety. Milk cholesterol levels were within previously established norms in the range of 10 mg/dL. The mothers reported no adverse outcomes in the two exposed infants. Conclusions: The transfer of atorvastatin and its metabolites was exceedingly low. While the impact on milk composition in states of hyperlipidemia (whether treated or untreated) is not well understood, it is unlikely that the drug in the milk would be present in clinically significant levels to adversely affect a breastfed infant.

Background: Use of cannabis during pregnancy and breastfeeding is increasing. Mental health concerns are reported as common reasons for maternal cannabis use, but little is known about the use of psychiatric medications in this population. Objectives: This study aimed to describe psychiatric medication use among pregnant and breastfeeding mothers who used cannabis for mental health concerns. Design: Anonymous, online cross-sectional survey. Methods: Data were collected from May 2018 to August 2019 among pregnant and breastfeeding mothers who used cannabis. This study included mothers who reported cannabis use for mental health concerns (n = 1363). The survey assessed the timing of cannabis use (during pregnancy and/or lactation); use of cannabis to address depression, posttraumatic stress disorder, or anxiety; use of psychiatric medications; psychiatric distress (Patient Health Questionnaire-4); and demographic information. Differences between groups were examined using t-test and chi-square test in SPSS. Results: The mean age was 29.7 years; most were married (62%); 74% were White non-Hispanic, 9% Hispanic, and 17% Black, Indigenous or other People of Color. Mental health symptoms prompting cannabis use included anxiety (96%), depression (75%), and posttraumatic stress disorder (36%). Only 24% of respondents (n = 322) reported concomitant use of psychiatric medications, primarily selective serotonin reuptake inhibitors (72%, n = 232) and benzodiazepines (21%, n = 68). The composite Patient Health Questionnaire-4 showed most respondents had no (61%) or mild (27%) psychological distress; 14% screened positive for depression; and 17% screened positive for anxiety. Respondents who used psychiatric medications more often screened positive mental health concerns. Conclusion: Most mothers who used cannabis for mental health concerns were not taking psychiatric medications. This may be due to a mismatch between perceived mental health and screening results, un- or under-treated mental illness, or preference for cannabis over psychiatric medications. Improved management of perinatal mental health and effective patient education about risks of cannabis versus medication use are needed.