FDA Adds Warning Label to Puberty Blockers

In July the U.S. Food and Drug Administration added a warning label to puberty blockers after six biological girls developed symptoms of tumor-like masses in the brain. One of the girls reportedly was receiving the puberty blockers for purposes of gender transition.

The new label warns of headache, papilledema, blurred or loss of vision, diplopia, pain behind the eye or pain with eye movement, tinnitus, dizziness, and nausea associated with tumor-like masses in the brain.

The FDA has approved puberty blockers to treat precocious puberty, among other things, but has never approved them for sex-change procedures.

Doctors who give puberty blockers to children for purposes of gender transition are doing so off label. That is part of the reason why many medical experts say giving puberty blockers to children for gender transition is “experimental” at best.

Last year the Arkansas Legislature passed the Save Adolescents From Experimentation (SAFE) Act.

The SAFE Act is an excellent law that protects children from sex-reassignment procedures, puberty blockers, and cross-sex hormones.

Unfortunately, the ACLU and others filed a lawsuit against the SAFE Act last summer, before the law officially took effect.

Several business interests and the Biden-Harris Administration also have joined the fight against Arkansas’ SAFE Act.

U.S. District Judge James Moody temporarily blocked the state from enforcing the law while the lawsuit progresses. 

Arkansas’ Attorney General asked the Eighth Circuit to lift his order so that the state can start enforcing the law right away. In June a three-judge panel heard arguments in that case.

The FDA’s warning label underscores the risks associated with giving puberty blockers to children. Arkansas’ SAFE Act protects children. We believe federal courts ultimately will recognize that fact and uphold this good law as constitutional.

Court Arguments Over Arkansas’ SAFE Act Scheduled for Next Week

A three-judge panel for the Eighth Circuit Court of Appeals will hear arguments next week over whether or not the State of Arkansas should be free to enforce the SAFE Act while a lawsuit over the act’s constitutionally progresses in court.

The Arkansas Legislature overwhelmingly passed the Save Adolescents From Experimentation (SAFE) Act last year.

The SAFE Act is an excellent law that protects children from sex-reassignment procedures, puberty blockers, and cross-sex hormones.

Researchers do not know the long term effects that puberty blockers and cross-sex hormones can have on kids.

That is part of the reason many experts agree that giving puberty blockers and cross-sex hormones to children is experimental, at best.

That is also why a major hospital in Sweden announced last year that it would no longer administer puberty blockers and cross-sex hormones to children.

Unfortunately, the ACLU and others filed a lawsuit against the SAFE Act last summer, before the law officially took effect.

Several business interests and the Biden-Harris Administration also have joined the fight against Arkansas’ SAFE Act.

Last July, U.S. District Judge James Moody temporarily blocked the state from enforcing the law while the lawsuit progresses. 

Arkansas’ Attorney General asked the Eighth Circuit to lift his order so that the state can start enforcing the law right away.

On Wednesday, June 15, a three-judge panel will hear arguments in that case.

According the Eighth Circuit Court of Appeals, Judges James B. Loken, Jane Kelly, and Katherine M. Menendez will hear the arguments.

President George H. W. Bush appointed Judge Loken to the Eighth Circuit, and he has served there since 1990.

Judge Kelly is one of President Obama’s appointees, and has been on the court since 2013.

Judge Menendez was appointed to the federal district court by President Biden last year.

Regardless of whether or not this panel lets Arkansas enforce the SAFE Act, the lawsuit over the SAFE Act’s constitutionality is progressing and will go to trial this October.

Arkansas’ SAFE Act protects children. We believe federal courts ultimately will recognize that fact and uphold this good law as constitutional.

Arkansas’ SAFE Act Passed One Year Ago Today

Above: Rep. Robin Lundstrum asks the Arkansas House of Representatives to override the governor’s veto of the SAFE Act in this file photo from April 6, 2021.

One year ago today the Arkansas Legislature voted to enact the Save Adolescents From Experimentation (SAFE) Act by Rep. Robin Lundstrum (R – Springdale) and Sen. Alan Clark (R – Lonsdale).

The SAFE Act protects children from sex-reassignment procedures, puberty blockers, and cross-sex hormones.

Here’s a brief recap of the measure’s history and what has happened since its passage:

On February 25, 2021, Rep. Robin Lundstrum (R – Springdale) and Sen. Alan Clark (R – Lonsdale) filed H.B. 1570, the Save Adolescents From Experimentation (SAFE) Act.

In a nutshell, the SAFE Act prohibits sex-reassignment procedures on children. It also prevents funding of sex-reassignment procedures performed on children.

Gender-reassignment surgeries can leave children sterilized and scarred for life, and medical researchers do not know the long term effects these procedures and therapies can have on kids. That is why many people equate them with experimenting on children.

On March 9, 2021, the SAFE Act passed the House Public Health Committee by a vote of 12 to 2, and it passed the entire Arkansas House of Representatives by a vote of 70 to 22 the following day.

Along the way, pro-LGBT organizations attacked the bill.

The ACLU claimed that the SAFE Act would ban “trans youth from accessing health care and health insurance.”

But groups like the Heritage Foundation pointed out that the SAFE Act does no such thing. The SAFE Act does not deny healthcare to anybody. It simply prohibits healthcare providers from performing or paying for sex-change procedures on children.

The Senate Public Health Committee passed the SAFE Act on Monday, March 22, 2021, and the full Arkansas Senate passed it the following week by a vote of 28 to 7.

Rev. Franklin Graham, Tony Perkins from Family Research Council, and the Heritage Foundation all issued statements supporting the SAFE Act.

However, Governor Asa Hutchinson vetoed the SAFE Act on April 5, 2021.

The following day — on April 6 — the Arkansas House and Arkansas Senate overwhelmingly voted to override the governor’s veto.

The SAFE Act was officially slated to take effect in July of 2021. However, the ACLU indicated in May that it would challenge the SAFE Act in court.

Meanwhile, on May 5 a major hospital in Sweden announced it would no longer give puberty blockers and cross-sex hormones to children under the age of 16, and that giving puberty blockers and cross-sex hormones to children ages 16 – 18 “should be regarded as experimental.” This echoed what many experts said during the debate surrounding Arkansas’ SAFE Act.

The ACLU filed the lawsuit over the SAFE Act on May 25, 2021.

On June 17 the Biden Administration weighed in against the SAFE Act, and six business organizations filed an amicus brief opposing the SAFE Act on July 2.

July 21, 2021, U.S. District Judge James Moody temporarily blocked the state from enforcing the SAFE Act while the lawsuit progresses.

On August 20 Arkansas Attorney General Leslie Rutledge asked the Eighth Circuit to lift Judge Moody’s order so that the state could start enforcing the law right away. That appeal is pending in federal court.

Meanwhile, the lawsuit over the SAFE Act’s constitutionality is still in Judge Moody’s court.

On February 28, 2022, the U.S. District Court in Little Rock announced the SAFE Act would go to trial sometime during the week of October 17, 2022. The court had previously scheduled the trial to take place during the week of July 25, 2022, but apparently chose to reschedule it.

Arkansas’ SAFE Act protects children.

Gender transition procedures, puberty blockers, and hormone replacements can sterilize children and leave them permanently scarred. The Save Adolescents From Experimentation Act protects children from these procedures.

We believe federal courts ultimately will recognize that fact and uphold this good law as constitutional.