The US Food and Drug Administration (FDA) warned that gonadotropin-releasing hormone (GnRH), known as puberty blockers, can cause loss of vision, brain swelling, and has serious risks for children..Six young girls between the age of five and 12 developed pseudotumor cerebri, which displays symptoms similar to a brain tumour while using puberty blockers..FDA officials said the plausible explanation was puberty blockers caused pseudotumor cerebri..“Five were undergoing treatment for central precocious puberty and one for transgender care,” said the FDA officials report. .“The onset of pseudotumor cerebri symptoms ranged from three to 240 days after GnRH agonist initiation.”.The six girls’ symptoms included visual disturbances, headaches, vomiting, increased blood pressure, brain swelling, and abducens neuropathy, which is damage to the cranial nerve causing muscle weakness or paralysis..An FDA spokesperson told Formulary Watch it considered what happened to the six girls to be “clinically serious” warranting a warning label for pediatric patients. .“The agency considered the cases clinically serious and, based on these reviews, determined that pseudotumor cerebri should be added as a warning and precaution in product labelling for all GnRH agonist formulations approved for use in pediatric patients,” said the FDA spokesperson to Formulary Watch. .The FDA said the “potential serious risk” associated with GnRH puberty blockers required the warning. .“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, this potential serious risk associated with GnRH agonists justifies inclusion in product labelling,” said the FDA spokesperson..US Assistant Secretary of Health Rachel Levine said the US should not put limits on puberty blockers and hormones, as they are “gender-affirming care.”.“Gender affirming care is life-saving, medically necessary, age-appropriate, and a critical tool for healthcare providers,” said Levine..“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.”.Florida’s department of Health instructed doctors to not prescribe puberty blockers or hormone therapy to children 18 years and younger, citing a lack of conclusive evidence and the potential for long-term and irreversible effects, contradicting Levine’s claims..“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,’” said Florida’s department of Health memo to doctors..Florida Health Department spokesperson Jeremy Redfern said Levine’s data is “an appeal to authority that is in stark contrast to the best available evidence.”
The US Food and Drug Administration (FDA) warned that gonadotropin-releasing hormone (GnRH), known as puberty blockers, can cause loss of vision, brain swelling, and has serious risks for children..Six young girls between the age of five and 12 developed pseudotumor cerebri, which displays symptoms similar to a brain tumour while using puberty blockers..FDA officials said the plausible explanation was puberty blockers caused pseudotumor cerebri..“Five were undergoing treatment for central precocious puberty and one for transgender care,” said the FDA officials report. .“The onset of pseudotumor cerebri symptoms ranged from three to 240 days after GnRH agonist initiation.”.The six girls’ symptoms included visual disturbances, headaches, vomiting, increased blood pressure, brain swelling, and abducens neuropathy, which is damage to the cranial nerve causing muscle weakness or paralysis..An FDA spokesperson told Formulary Watch it considered what happened to the six girls to be “clinically serious” warranting a warning label for pediatric patients. .“The agency considered the cases clinically serious and, based on these reviews, determined that pseudotumor cerebri should be added as a warning and precaution in product labelling for all GnRH agonist formulations approved for use in pediatric patients,” said the FDA spokesperson to Formulary Watch. .The FDA said the “potential serious risk” associated with GnRH puberty blockers required the warning. .“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, this potential serious risk associated with GnRH agonists justifies inclusion in product labelling,” said the FDA spokesperson..US Assistant Secretary of Health Rachel Levine said the US should not put limits on puberty blockers and hormones, as they are “gender-affirming care.”.“Gender affirming care is life-saving, medically necessary, age-appropriate, and a critical tool for healthcare providers,” said Levine..“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.”.Florida’s department of Health instructed doctors to not prescribe puberty blockers or hormone therapy to children 18 years and younger, citing a lack of conclusive evidence and the potential for long-term and irreversible effects, contradicting Levine’s claims..“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,’” said Florida’s department of Health memo to doctors..Florida Health Department spokesperson Jeremy Redfern said Levine’s data is “an appeal to authority that is in stark contrast to the best available evidence.”
