A transgender woman may have become the first to be able to breastfeed his baby — with the help of a banned drug that some pediatricians warn has "significant toxicity."
The peer-reviewed journal Transgender Health published a case study last month highlighting a 30-year-old unnamed biologically male transgender woman who is believed to be first case of "induced lactation in a transgender woman" reported in medical literature.
The study states that while the transgender woman's partner was pregnant and not interested in breastfeeding, the transgender woman was more than willing to take on the role of providing the baby's primary food source.
According to the study, the transgender woman has not received any kind of "gender-affirming" surgery. But with the help of extensive hormone therapy, the study states that the transgender woman was able to breastfeed their child naturally for at least six months.
Tamar Reisman, the study's co-author and an endocrinologist at Mount Sinai Hospital in New York, told The Washington Post that doctors used protocals for "non-puerperal induced lactation," a process used to help women lactate.
Spironolactone was used to to suppress testosterone, while estradiol and progesterone were used to mimic the high levels of the hormones produced during pregnancy.
Domperidone, a vomiting medication to increase milk production and banned by the Food and Drug Administration, was also used, along with a breast pump.
The fact that domperidone has not been approved for sale by the FDA should be cause for concern, according to critics of the process. According to the FDA, there are "serious risks associated with domperidone." They risks include cardiac arrhythmias, cardiac arrest, and sudden death."
"These risks are related to the blood level of domperidone, and higher levels in the blood are associated with higher risks of these events," the FDA states. "Concurrent use of certain commonly used drugs, such as erythromycin, could raise blood levels of domperidone and further increase the risk of serious adverse cardiac outcomes."
The domperidone used in the study was acquired by the couple in Canada.
"Domperidone, the drug used to aid in production of breast milk in this genetic male, is not approved for any use in the United States because of significant toxicity and potential death," Queentin L. Van Meter, a specialist in pediatric endorcinology based in Georgia and vice president of the the national conservative adovcacy group American College of Pediatricians, said in a statement shared with The Christian Post.
"There are absolutely no studies in infants," he continued. "Any drug ingested by a lactating mother should be also proven to be safe for ingestion by the suckling infant. This is clearly not the case. "
According to the Canadian Breastfeeding Foundation, "the amount of domperidone that gets into the milk is very small."
"[F]rom the baby's point of view, there should be no issue in the mother taking it to increase milk supply for several months," the foundation's website explains. "Our experience with this drug is that short-term side effects are very few and almost always very mild. Worldwide experience with domperidone over at least two decades suggests that long-term side effects also are rare."
"Some of the mothers in our clinic, breastfeeding adopted babies, have been on the medication for 18 months without any apparent side effects," the website adds. "Patients using domperidone for stomach disorders may be on it for many years. I hope you won't need domperidone for very long, but if it's necessary and helpful, stay on it."
According to the new study by Reisman and her colleague Zil Goldstein, the transgender patient had the first follow-up appointment after one month of therapy and was able to "express droplets of milk." At three months after starting the therapy, the patient was able to produce eight ounces of breastmilk per day.
Three-and-a-half months after beginning the hormone regimen, the baby was born weighing six pounds and 13 ounces. After breastfeeding exclusively for six weeks, the study explains that the child's doctor reported the "child's growth, feeding, and bowel habits were developmentally appropriate."
At six weeks after the baby was born, the transgender woman began supplementing breast feedings with about four to eight ounces of baby formula every day because of insufficient milk volume.
"At the time of this article submission, the baby is approaching [six] months old. The patient continues to breastfeed as a supplement to formula feeding, and she continues to adhere to the medication regimen described earlier," the study states.
Jenny Thomas, a spokesperson for the American Academy of Pediatrics and a lactation consultant for Aurora Health Care in Wisconsin, told The Washington Post that inducing lactation is very common. Thomas didn't expect the addition of spironolactone to block testosterone would be much of an issue.
"We wouldn't expect spironolactone to get into the breast milk," Thomas said.
Although the process hasn't seemingly affected the health of the baby, health experts still have concerns about the long-term effects.
University of California at San Francisco professor and doctor Madeline Deutsch and a transgender woman with a six-month old son told The Washington Post that she is wary because of the lack of research on whether or not breast milk produced by transgender women has the same nutritional value.
Deutsch stated that it was "not something I would do."
"This is not transgender women taking control of their bodies," Deutsch said. "This is something that needs to be explored more."
Van Meter agrees. He told CP that the experimental breastfeeding featured in the study is an example of how the "wishes of the adult are being met at the expense of the health and safety of the infant."
"The American College of Pediatricians cannot condone the use of domperidone as was reported in this case," he stated.
American College of Pediatricians President Michelle Cretella, a prominent critic of using hormone therapy on children, told CP in an email that the breasfeeding ability for the trasngender woman does not "change his male DNA nor can it make male breast tissue into female breast tissue which are genetically different."
"It is therefore likely that whatever his breasts produced is qualitatively different from what any real woman's breast would produce," she explained. "This is still a man impersonating a woman and experimenting on an infant."