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A new review has been published highlighting different studies’ findings on the use of various alopecia therapies among breastfeeding mothers, with a detailed discussion provided on each medication’s transference to breast milk, blood serum levels in infants, potential adverse events among neonates, and other clinical considerations.¹

These data were all authored by a team of investigators, led by Carli D. Needle, an MD candidate at The Ronald O. Perelman Department of Dermatology at New York University’s Grossman School of Medicine. Needle et al noted that alopecia areata, androgenetic alopecia (AGA), and cicatricial alopecia can each lead to negative physical symptoms and notable psychological distress among patients and women in particular.²

“Given the limited research in this area and the importance of avoiding interruptions in alopecia treatment, this review aims to help guide clinicians in choosing safe and appropriate hair loss therapies for women during lactation,” Needle and coauthors wrote.¹

Design and Findings

The trial investigators carried out their literature searches using the Scopus, PubMed, and Web of Science databases. Searches were done only in English. Existing safety databases such as the Drugs and Lactation Database (LactMed) and the United States Food and Drug Administration (FDA) Drug Database were also used by the team, and any primary literature cited by these databases was further examined when accessible. Terms included the medication names and classes assessed by this review, as well as “lactation” and “breastfeeding.” Searches were done from November 2024 – December 2024.

The investigators noted the increasing systemic and topical medication use in alopecia treatment. The hair regrowth medication minoxidil is generally classified as low-risk during lactation, with oral being documented in breastfeeding mothers without complications. Nevertheless, because of possible transmission through skin contact or milk, cautious utilization of minoxidil is still being advised, especially in premature infants or neonates.

Needle and coauthors highlighted that Janus kinase inhibitors (JAKi), which reduce inflammation by targeting T-cell signaling pathways, are among some of the most effective. Approved JAKis for alopecia areata include baricitinib, deuruxolitinib, and ritlecitinib. As a result of their small molecular size, JAK inhibitors can pass into breast milk, contributing to concerns about infant exposure.

Tofacitinib appears in human breast milk within hours of ingestion, leading to current guidelines to avoid breastfeeding while implementing it. For other JAKis, such as baricitinib and ritlecitinib, lactation safety data are limited, though pharmacokinetic modeling suggests drug levels fall below clinical significance within several half-lives. Given uncertainty, those using such drugs are typically advised to pause breastfeeding during active JAKi use.

Needle and colleagues pointed to a variety of other research, noting different recommendations based on the drugs available for alopecia. Methotrexate, for example, only enters breast milk in small amounts but its active metabolite can linger in neonatal tissues as a result of immature infant kidney function. Even low levels of exposure is linked to potential developmental toxicity, so methotrexate is contraindicated during breastfeeding.

Other data highlighted by the investigative team included diphencyprone (DPCP), a topical option often used in alopecia areata that also acts as a contact allergen, triggering localized immune responses to encourage hair regrowth. Despite noted minimal systemic absorbtion, rare reports of DPCP entering circulation do exist. The lack of robust data, the team suggest, suggests a need for caution until further research is available.

The investigators further highlighted azathioprine that is now applied in autoimmune dermatologic conditions, noting that most experts recommend waiting a few hours after dosing before breastfeeding to allow peak concentrations of the medication to subside. They further pointed to cyclosporine, adding that variable transmission into breast milk has been observed with the drug and largely depends on the formulation. Generally, cyclosporine is considered compatible with breastfeeding, though infants should be monitored for potential adverse effects.

The Excimer laser, a narrow-band ultraviolet B (NB-UVB) therapy used to manage autoimmune scalp conditions, was noted as effective and generally safe, though folate supplementation was highlighted as necessary for consideration in postpartum mothers given this treatment. Needle et al pointed to data suggesting poor absorbtion of topical vitamin D analogues like calcipotriene during lactation, but noted that oral vitamin D is safe up to 10,000 IU daily, and supplementation in the mother may benefit infants given low levels of breast milk vitamin D.

For androgenetic alopecia, spironolactone is an anti-androgen agent that appears in breast milk only in trace amounts and has not been linked to infant harm. In a similar vein, topical clascoterone was shown to have lower systemic absorption, though safety during lactation was noted as not well established. Other findings in the review suggest that progestin-only pills, particularly drospirenone, have no adverse effects among breastfed infants when introduced after 6 weeks postpartum.

Other topical treatments like ketoconazole 2% shampoo, often implemented in scalp inflammation, were noted as safe resulting from their negligible levels of systemic absorption. Low-level laser therapy (LLLT), frequently utilized in hair regrowth procedures, is also regarded as safe during lactation due to its noninvasive nature and lack of drug interaction. Platelet-rich plasma (PRP) was shown by the investigators’ review to pose minimal risk for breastfed infants. Some natural or plant-based therapies, including saw palmetto and rosemary oil, had less data and were not recommended.

For scarring (cicatricial) alopecias, topical tacrolimus is considered to be safe due to limited systemic absorption, though available data suggests direct contact with the infant skin should be avoided. Hydroxychloroquine was noted by Needle et al as being excreted in small amounts into breast milk, though it has not been linked to harms among infants. The antibiotic doxycycline was shown by the team to generally be safe for short-term use during lactation.

They highlighted that mycophenolate mofetil is not considered safe during breastfeeding given the high transfer into milk and risks linked to its use such as infections or developmental delays. Pioglitazone, a metabolic agent, is also shown to have produced harmful effects in animal studies and should be avoided. The investigators did, however, highlight the safety of low-dose naltrexone, sometimes used off-label for inflammatory conditions, which has shown minimal transmission into milk.

Clindamycin and rifampicin, both antibiotics used for inflammatory scalp conditions, are compatible with breastfeeding. However, Needle and coauthors did note that infants should be monitored for any GI symptoms. Retinoids like isotretinoin and acitretin were noted as being contraindicated given their high risk of toxicity and birth defects. In contrast, topical retinoids were shown to be likely safe.

The review also highlighted tumor necrosis factor (TNF) inhibitors such as adalimumab, primarily utilized in resistant inflammatory alopecias, which data suggest do appear in breast milk at very low levels. The protein molecules are broken down in an infant’s gut and are not absorbed systemically, making them compatible with breastfeeding.

“Although breastfeeding confers well-established health benefits, some individuals may choose to prioritize treatment for alopecia over continued breastfeeding, especially when effective therapies are not fully validated as compatible with lactation,” they wrote.¹ “It is therefore crucial for providers to understand the risk of systemic absorption…in order to make informed decisions and safe recommendations to breastfeeding patients.”

References

1. CD Needle, AL Brinks, CA Kearney, et al. “Alopecia Treatments in Breastfeeding: Safety and Clinical Considerations,” International Journal of Dermatology (2025): 1–20, https://doi.org/10.1111/ijd.17940.

2. N Hunt and S McHale. “The Psychological Impact of Alopecia,” BMJ 331, no. 7522 (2005): 951–953, https://doi.org/10.1136/bmj.331.7522.951.

Early childhood vaccines containing aluminum are not linked to a higher risk for developing autoimmune, allergic, or neurodevelopmental disorders, according to a nationwide study of Danish children.

The study, which looked at more than 1.2 million children over 24 years, provides additional evidence supporting the safety of aluminum-adsorbed vaccines, said senior author Anders Peter Hviid, MSc, DMSc, of Statens Serum Institut in Copenhagen.

“Our results provide robust evidence to help parents make the right decisions about the health of their children and for clinicians and public health officials to communicate about the excellent safety of the childhood vaccines,” Hviid told Medscape Medical News. “It’s understandable that more and more parents are concerned about vaccine safety, given the mixed messages that they receive currently. We hope that our study can help settle the issue on this particular concern.”

Aluminum adjuvants have been used in non-live vaccines to boost immune response for nearly a century. While years of research have demonstrated the safety of these adjuvants, concerns about potential risk remain. Robert F. Kennedy Jr, secretary of the US Department of Health and Human Services, has blamed exposure to aluminum in vaccines for widespread allergies, and one of his close associates has petitioned regulators to halt distribution of certain vaccines until the makers of those shots provide more information about the amount of the metal in their products. 

Findings from animal studies have mostly driven concerns about aluminum in vaccines, Hviid and his colleagues wrote; however, a 2022 study looking at more than 326,000 US children did find a positive association between vaccine-associated aluminum and asthma. 

“I think it’s fair to say that in part our study was inspired by that report,” said Hviid, whose group published the findings July 14 in Annals of Internal Medicine. 

Linking Vaccination Records to Outcomes

Researchers included 1.24 million children born in Denmark from 1997 to 2018. Eligibility required survival to age 2 years without congenital or preexisting conditions, including congenital rubella syndrome, respiratory disease, primary immune deficiency, or heart or liver failure.

Researchers obtained vaccination information from Denmark’s National Health Service Register and, for each child, calculated the total aluminum exposure by age 2. Since 1997, the Danish childhood vaccination program has offered an aluminum-containing vaccine against diphtheria, tetanus, acellular pertussis, poliovirus, and Haemophilus influenzae type b (Pentavac) in three doses at 3, 5, and 12 months. Since 2007, the program also offers an aluminum-adsorbed pneumococcal conjugate vaccine, also given in three doses in the first year of life. 

Researchers then tracked patient outcomes from age 2 to age 5 (or until Dec 31, 2020), looking for diagnoses of 50 chronic autoimmune, atopic or allergic, and neurodevelopmental disorders — including juvenile arthritis, asthma, and autism spectrum disorders. 

The median cumulative aluminum exposure for the cohort was 3 mg, with a range from 0 mg to 4.5 mg. Only 15,237 children received no aluminum-containing vaccines during the study period. 

Excluding Risk ‘With Great Certainty’

The analysis found no relationship between cumulative exposure to aluminum in vaccines and any of the 50 selected conditions. For any autoimmune disorder, the adjusted hazard ratio (aHR) per 1 mg of aluminum exposure was 0.98 (95% CI, 0.94-1.02). The aHR was 0.99 (95% CI, 0.98-1.01) for any atopic or allergic outcome and 0.93 (95% CI, 0.90-0.97) for any neurodevelopmental outcome.

The most observed conditions during the study period were asthma (28,346 cases) and atopic dermatitis (22,978 cases). The researchers found no association between either condition and cumulative exposure to aluminum in vaccines. 

“For some of the key outcomes that people are most interested in, like asthma and autism spectrum disorders, the results are quite clear, and we can exclude meaningful increases in risk with great certainty,” Hviid said. 

Some of these associations even demonstrated a slightly decreased risk — for example, autism spectrum disorders; however, with confidence intervals close to one, “we don’t interpret this as relevant protective effects,” he said. 

Secondary analyses that extended follow-up to 8 years of age, removed all children with no exposure to aluminum-containing vaccines, and restricted the analysis to complete cases also found no association between these chronic conditions and exposure to vaccines containing aluminum.

“With all these adjustments, they still didn’t find any differential in the effect. I think all of that is very reassuring,” said James Campbell, MD, MS, a professor in the Department of Pediatrics at the University of Maryland School of Medicine in Baltimore. 

This paper “adds to the long history of studies” on the safety of aluminum-containing vaccines, said Campbell, who also is vice chair of the committee on infectious diseases for the American Academy of Pediatrics.

“Aluminum salts have been around for almost 100 years as an adjuvant; we have such a long history of using them, both in the United States and across the world,” Campbell told Medscape. “The aggregate of the data are that aluminum salt adjuvants are safe to be given to children.”

This research was funded by the Danish Government. The study authors reported no relevant financial relationships. Campbell reports serving as a site primary investigator for vaccine trials with institutional funding from Pfizer, Moderna, GSK, Sanofi, and Merck.