Manufacturers that dominate the U.S. market for puberty blockers refuse to conduct safety trials on their frequently prescribed off-label use to treat gender dysphoria in adolescents. Endo International plc and AbbVie Inc have repeatedly declined to conduct safety tests on the puberty blocking drug Lupron, according to a new report by Reuters.
Left-wing news outlet Reuters published data on Thursday about the rising number of children and adolescents adopting a transgender identity and seeking medical interventions. Among the shocking revelations is that between 2017 to 2021, 17,683 of the 121,882 children ages 6 to 17 diagnosed with gender dysphoria received puberty blockers or cross-sex hormones. Despite such widespread adoption for the drug’s off-label use, the drug’s manufacturers refuse to conduct safety trials for their use in treating gender dysphoria in adolescents.
Dr. Brad Miller, division director of pediatric endocrinology at the University of Minnesota Medical School and M Health Masonic Children’s Hospital, and “several other doctors,” told Reuters they had “repeatedly asked” AbbVie, Endo, and other manufacturers of puberty blockers to seek FDA approval for the drugs in treating gender dysphoria in children and to conduct clinical trials to establish their safety. “They said the companies always declined,” reported Reuters.
“They would say it would cost a lot of money to get approval,” Miller said of the drug manufacturers’ refusal. “And they were not interested in going there because (transgender treatment) was a political hot potato.”
Miller told Reuters he was “particularly concerned” because doctors prescribe puberty blockers for trans-identifying children, who are “already at higher risk of mental health problems.”
Reuters attempted to reach AbbVie, but they declined to give comment. “An Endo spokeswoman said the company has no plans to seek regulatory approval for the use of its drug for any new indications,” said Reuters, adding, “The company did not respond to requests for further comment for this article.”
Puberty blocking drugs are only FDA-approved for their use in treating central precocious puberty, a condition caused by pituitary gland dysfunction in which children begin to sexually mature before age 8 or 9. They are not approved for their off-label use in treating gender dysphoria in adolescents, which is during a critical window of brain and body development. Many of the existing published data pertain only to precocious puberty patients.
Reuters reported on the side effects of puberty blocking drugs prescribed to children, which include a decline in bone density, neurological effects, and psychiatric problems.
Reuters reported they have found 72 adverse event reports submitted to the FDA from 2013 through 2021 of children on puberty blockers who showed “suicidal, self-injurious, or depressive behavior.” This data includes taking the drug for either central precocious puberty or gender dysphoria, some of which were identified simply as “under 18,” Reuters noted.
In 2016, the FDA ordered puberty blocking drugmakers to add a warning about psychiatric problems to the drugs’ labels as a treatment for children with precocious puberty. On its label for Lupron, the brand name of the puberty blocking drug leuprolide, AbbVie says: “Psychiatric events have been reported in patients” taking puberty blockers. Events include emotional symptoms “such as crying, irritability, impatience, anger and aggression.”
On the potential neurological effects of puberty blockers, some scientists and doctors have voiced concerns, Reuters said. “Hormones released during puberty play a major role in brain development, so when puberty is suppressed, can that result in reduced cognitive function, such as problem solving and decision making?” Reuters asked.
A 2020 paper by Dr. John Strang, research director of the gender development program at Children’s National Hospital, and other researchers wrote that “pubertal suppression may prevent key aspects of development during a sensitive period of brain organization.”
Reuters quoted Strang as saying, “we need high-quality research to understand the impacts of this treatment – impacts which may be positive in some ways and potentially negative in others.”