Puberty blockers, known as gonadotropin-releasing hormone (GnRH) substances, received a warning from U.S. Food and Drug Administration (FDA) officials earlier this month, saying the drug could cause brain swelling, loss of vision, and serious risks for children injecting the hormone.
Officials said a plausible association between using puberty blockers and pseudotumor cerebri, which displays symptoms similar to a brain tumor, was identified in six young girls between the ages of 5 and 12.
“Five were undergoing treatment for central precocious puberty and one for transgender care,” FDA officials report. “The onset of pseudotumor cerebri symptoms ranged from three to 240 days after GnRH agonist initiation.”
Such symptoms in the patients included visual disturbances, headaches, and vomiting. Other effects GnRH agonists caused were an increase in blood pressure, brain swelling, and abducens neuropathy.
A spokesperson from the FDA told Formulary Watch the cases were considered clinically serious and determined that a warning should be added to all GnRH agonist products approved for pediatric patients.
“Although the mechanism by which GnRH agonists may lead to development of pseudotumor cerebri has not been elucidated, and patients with CPP may have a higher baseline risk of developing pseudotumor cerebri compared with children without CPP,” the spokesperson said. “This potential serious risk associated with GnRH agonists justifies inclusion in product labeling.”
Puberty blockers and hormones have come under fire again after President Joe Biden’s U.S. Assistant Secretary of Health Rachel Levine asserted that the U.S. should not limit youth access to so-called “gender-affirming care.”
“Gender affirming care is life-saving, medically necessary, age-appropriate, and a critical tool for health care providers,” Levine said. “As a pediatrician, when it comes to making sure kids are healthy and happy, I know how important care that affirms someone’s true identity can be.”
However, Florida’s Department of Health has argued the opposite of Levine’s claims, saying that due to the lack of conclusive evidence, and the potential for long-term and irreversible effects, doctors should not prescribe children 18 years old and younger puberty blockers or hormone therapy.
“Based on the currently available evidence ‘encouraging mastectomy, ovariectomy, uterine extirpation, penile disablement, tracheal shave, the prescription of hormones which are out of line with the genetic make-up of the child, or puberty blockers, are all clinical practices which run an unacceptably high risk of doing harm,'” Florida’s Department of Health wrote in a memo.
Yet Levine claims every major medical association agrees with the comments about “gender-affirming” care saving lives, according to Fox News.
Jeremy Redfern, a Florida Health Department spokesperson, denounced Levine’s so-called data.
“It’s an appeal to authority that is in stark contrast to the best available evidence,” Redfern said.
He said while the state’s Health Department is following the evidence, the federal government is following the eminence.