FDA: Puberty Blockers May Cause Brain Swelling, Blindness

[Leroy N. Soetoro]

https://thenewamerican.com/fda-puberty-blockers-may-cause-brain-swelling-
blindness/

The U.S. Food and Drug Administration (FDA) added a warning to the label
of gonadotropin-releasing hormone (GnRH) agonists, commonly known as
puberty blockers, indicating that young people who take them might develop
serious adverse reactions such as brain swelling and vision loss.

According to the FDA update posted on the American Academy of Pediatrics
(AAP) on July 1, the new warning includes recommendations to monitor
patients taking GnRH agonists for signs and symptoms of pseudotumor
cerebri. That is a condition that occurs when pressure inside the skull
increases “for no obvious reason,” according to the Mayo Clinic. Its
definition adds, “Symptoms mimic those of a brain tumor. The increased
intracranial pressure can cause swelling of the optic nerve and result in
vision loss.”

Other symptoms include headache, papilledema (swelling of the optic nerve
inside of the eye), blurred or loss of vision, diplopia (double vision),
pain behind the eye or pain with eye movement, tinnitus (perception of
sound when no corresponding external sound is present), dizziness, and
nausea.

The article says that according to the post-marketing data submitted by
the manufacturer of the puberty blocker in question, six cases of brain
swelling and the associated symptoms were reported in girls ages 5 to 12
years. “Five were undergoing treatment for central precocious puberty and
one for transgender care,” notes the agency.

To treat the affected girls, the doctors used such invasive procedures as
lumbar puncture (insertion of a needle into the spinal canal, most
commonly used to collect cerebrospinal fluid for diagnostic testing) and
ventricular peritoneal shunting (insertion of a medical device that
relieves pressure on the brain caused by fluid accumulation), as well as
therapy with acetazolamide (a diuretic and protein inhibitor medication).

By the time the FDA looked into what happened to these girls, symptoms had
resolved in three of them and were resolving in one. One was still
suffering. What happened to the last one is “unknown.” “Treatment” with
puberty blockers was discontinued in just three girls. The FDA said it had
no knowledge of the remaining three patients getting off the GnRH agonist.

The FDA determined that the link between the severe condition and the
medication is vague:

The incidence rate of pseudotumor cerebri associated with GnRH agonist use
in pediatric patients could not be reliably established due to the small
number of cases and data limitations.

Yet the change of labeling appears to be made even earlier, in May, as
reported by Formulary Watch, and applies to such medications as Fensolvi
Kit, Lupron Depot-Ped Kit, Supprelin LA, Synarel, and Triptodur Kit.

GnRH is prescribed to stop the production of female hormones such as
estrogen and progesterone, and is used to treat advanced prostate cancer,
endometriosis, uterine fibroids, cancer, precocious puberty, and
infertility.

The new warning reads:

Pseudotumor cerebri (idiopathic intracranial hypertension) has been
reported in pediatric patients receiving GnRH agonists, including
leuprolide acetate. Monitor patients for signs and symptoms of pseudotumor
cerebri, including headache, papilledema, blurred vision, diplopia, loss
of vision, pain behind the eye or pain with eye movement, tinnitus,
dizziness, and nausea.

Speaking with the outlet, the FDA spokesperson clarified that the cases
were serious enough for the agency to warn parents and caregivers about
them.

“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 representative stated, adding that youths diagnosed with
central precocious puberty (CPP), or premature puberty, may be at a higher
risk of developing pseudotumor cerebri compared with children without CPP.

The Family Research Council’s director of the Center for Family Studies,
Dr. Jennifer Bauwens, told The Washington Stand that because “Our bodies
were not made for these drugs,” giving them to children “isn’t going to
have a good outcome.”

The latest development around puberty blockers went unnoticed by the
mainstream media, yet it raises a serious question about the official
position of the Biden administration, which views them as “lifesaving
drugs.”

Speaking in June, Assistant Secretary for Health “Rachel” Levine, the
highest ranking “trans” person in the government, said that “gender-
reaffirming” medical “care” is a “life-saving, medically necessary,” and
“age-appropriate critical tool” to keep children “happy and healthy.”


At the end of April, Levine said that medical professionals have reached a
consensus on the value of gender-affirming care for “transgender”
children.

“There is no argument among medical professionals — pediatricians,
pediatric endocrinologists, adolescent medicine physicians, adolescent
psychiatrists, psychologists, etc. — about the value and the importance of
gender-affirming care,” Levine, a medical doctor trained in pediatrics and
adolescent medicine, told NPR.

In May, Health and Human Services (HHS) Secretary Xavier Becerra went so
far as to state that he was all for “transgender” children and their
physicians deciding to use off-label, experimental puberty blockers.

As reported by The New American, Becerra testified before the U.S. Senate
that if any medication was unsafe, the FDA would “raise the alarm” about
it.

And as we reported in late March, the HHS launched a new website that
offers “resources for transgender and LGBTQI+ youth, their parents, and
providers,” the goal of which is to “affirm an LGBTQI+ child.” According
to the site, when children and adolescents believe that their “gender
identity” does not match their biology, they should be offered not only
support from mental-health “councils” to “reaffirm” the perceived
“identity,” but could also be prescribed medications blocking their
biological hormones and life-altering surgeries on their faces, breasts,
and genitals.

The HHS resource is only a tiny part of the Biden administration’s much
broader pro-trans agenda, which includes policies ranging from
“reinforcing federal protections for transgender children” to improving
transgender travel experiences.



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