As Biden Admin Pushes Gender Changes for Kids, FDA Warns of Brain Swelling from Puberty Blockers
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While the Biden administration is doing everything it legally can to push gender change procedures for children, the Food and Drug Administration (FDA) is warning of serious side effects caused by puberty blockers.
The FDA announced a warning earlier this month about puberty blockers known as gonadotropin-releasing hormone agonists (GnRH) that if injected into children could cause swelling of the brain, headache, blurred or loss of vision, tinnitus, dizziness, and nausea.
The FDA said six cases were identified in young girls aged 5 to 12 years that had a plausible association between the puberty blockers use and pseudotumor cerebri, which the Mayo Clinic identifies as pressure inside the skull increasing for no obvious reason. The condition is also identified as idiopathic intracranial hypertension in which symptoms mimic a brain tumor.
Five of the girls were undergoing treatment for central precocious puberty and one for transgender care, the FDA said. The onset of symptoms ranged from three to 240 days after the girls began taking the puberty blockers.
Almost two months before the FDA's warning was issued, an FDA spokesperson told Formulary Watch that the agency considered the cases clinically serious and, based on their reviews, determined that pseudotumor cerebri (idiopathic intracranial hypertension) should be added as "a warning for all GnRH agonist product labeling 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, this potential serious risk associated with GnRH agonists justifies inclusion in product labeling," the spokesperson said.
This information from the FDA contradicts President Biden's Assistant Secretary of Health Rachel Levine's assertion 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," Levine said in a DNC Pride Month Grassroots Town Hall last month.
Levine, who is transgender, has been a practicing physician for more than two decades.
Biden official Rachel Levine: Sex reassignment surgery and puberty blockers for KIDS is “lifesaving, medically necessary, age appropriate, and a critical tool” pic.twitter.com/OwSOA3cjj8— RNC Research (@RNCResearch) June 27, 2022
Currently, four states – Alabama, Arkansas, Arizona and Texas – have passed laws barring gender-altering procedures including the use of puberty blockers, hormone treatments, or surgical procedures for children and adolescents experiencing gender dysphoria. But three of those state's laws (Alabama, Arkansas, and Texas) have been temporarily blocked by judges. Arizona's law does not go into effect until March 31, 2023.
As CBN News reported last April, Florida's Department of Health (DOH) rebuked the guidance issued by the Biden administration on gender dysphoria treatment for children and adolescents, releasing its own guidelines instead.
The Sunshine State said that puberty blockers and cross-sex hormones should not be used to treat gender confusion in children
"A paper published in the International Review of Psychiatry states that 80% of those seeking clinical care will lose their desire to identify with the non-birth sex," the memo continued. "One review concludes that 'hormonal treatments for transgender adolescents can achieve their intended physical effects, but evidence regarding their psychosocial and cognitive impact is generally lacking," the Florida DOH wrote in its memo.
"The federal government's medical establishment releasing guidance failing at the most basic level of academic rigor shows that this was never about health care," Florida Surgeon General Joseph Ladapo said in a press release. "It was about injecting political ideology into the health of our children. Children experiencing gender dysphoria should be supported by family and seek counseling, not pushed into an irreversible decision before they reach 18."
Biden's Trans Focus Reinterprets Title IX, More Than 20 States Attorneys General Take Administration to Court
Meanwhile, the Biden administration has a new interpretation of Title IX. As CBN News reported, any student must be allowed into any space they identify with or schools will risk the loss of federal funding.
The Biden administration wants all schools that receive federal help to provide open access to bathrooms, locker rooms, and sports, based on students' self-perceived gender identity. But that desire is hitting some legal roadblocks.
Some states are pushing back on the new proposed rules for schools regarding students who identify as transgender. On Tuesday, more than 20 attorneys general sued the administration over its policy that could undermine school meal programs.
They argue the Biden administration wrongly expanded the 2020 Supreme Court Bostock decision. That ruling stated that under federal employment law, sex discrimination includes gender identity and sexual orientation. Later, the Biden administration expanded Bostock's reach to include Title IX and education.
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