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FDA Warns: Puberty Blockers May Cause Brain Swelling and Vision Loss in Children

FDA, El American

Available: Español

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THE FOOD AND DRUG ADMINISTRATION (FDA) has warned about the potential harm that so-called “puberty blockers,” drugs administered to prepubertal patients undergoing surgical sex change or to minors experiencing early puberty, can cause in the brains of minors.

These drugs, known as gonadotropin-releasing hormone (GnRH) agonists, can cause idiopathic intracranial hypertension, a brain pseudotumor that develops when the pressure inside the skull spontaneously increases, which can lead to brain swelling, severe headaches, nausea, double vision, and even permanent vision loss.

According to a report from the American Academy of Pediatrics (AAP), the FDA identified six cases of idiopathic intracranial hypertension in girls aged 5 to 12 years taking hormone blockers and established an association between the drug and the condition is “plausible.”

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An FDA spokesperson said that biopharmaceutical AbbVie, which markets one of the best-known puberty blockers (Lupron), identified several publications describing the development of brain pseudotumor in children with central precocious puberty who had been treated with GnRH agonist drugs.

“The agency considered the cases clinically serious and, based on these reviews, determined that pseudotumor cerebri (idiopathic intracranial hypertension) should be added as a warning and precaution in product labeling for all GnRH agonist formulations approved for use in pediatric patients,” the FDA spokesperson told Formulary Watch.

The spokesperson clarified that, although the mechanism that generates the consequences in the brain has not been elucidated, patients with central precocious puberty may be at increased risk. However, the “serious risk” of developing a pseudotumor cerebri is sufficient justification for adding a warning label to the product.

FDA vs. the Assistant Secretary for Health

The FDA’s finding appears to contradict Rachel Levine, the Biden administration’s Assistant Secretary for Health, who recently said that “gender-affirming care,” including the use of puberty blockers, can be “life-saving” and is “medically necessary” for children.

Levine, a transgender woman, believes that anyone seeking to prevent the medical and surgical intervention of children in terms of sexual identity is “opponent of LGBTQ equality.”

The Assistant Secretary for Health also referred to the steps the state of Florida, under the Ron DeSantis administration, has taken to prevent the indoctrination and sexualization of children in schools and argued that children are victims of political attacks.

According to Florida Department of Health spokesman Jeremy T. Redfern, Levine’s claims are a “poorly attempted character assassination” against other physicians or against parents who oppose subjecting their children to such treatments.

“The Surgeon General is opposed to experimental and irreversible medical treatments on children and teenagers that suffer from gender dysphoria,” Redfern told Fox News Digital. “The idea that this makes anyone at the Department of Health an ‘opponent of LGBTQ equality’ is nothing more than a poorly attempted character assassination.”

Tomás Lugo, journalist and writer. Born in Venezuela and graduated in Social Communication. Has written for international media outlets. Currently living in Colombia // Tomás Lugo, periodista y articulista. Nacido en Venezuela y graduado en Comunicación Social. Ha escrito para medios internacionales. Actualmente reside en Colombia.

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