Texas Attorney General Ken Paxton is investigating two pharmaceutical companies for allegedly advertising and promoting hormone blockers, or puberty blockers, for uses not relating to its original intended usage, and for not disclosing potential drug side effects to parents and children.
Paxton announced in a Dec. 13 press release that his office is investigating Endo Pharmaceuticals, Inc. and AbbVie Inc. under the Texas Deceptive Trade Practices Act.
"Medications Supprelin LA and Lupron Depot are approved to treat children with Central Precocious Puberty (CPP), when the puberty process begins prematurely. And Vantas, along with other forms of Lupron, has been prescribed for palliative treatment of prostate cancer," the press release states.
These drugs are reportedly being used to treat gender dysphoria in children, which is not what these drugs were originally approved for by the Food and Drug Administration.
"The manufacture, sale, prescription, and use of puberty blockers on young teens and minors is dangerous and reckless," Attorney General Ken Paxton said. "These drugs were approved for very different purposes and can have detrimental and even irreversible side effects. I will not allow pharmaceutical companies to take advantage of Texas children."
"Puberty blockers used on minors experiencing gender dysphoria or similar mental disorders is child abuse," Paxton told Fox News in a statement Wednesday. "Doctors, parents, guardians, and counselors who aid and abet the use of puberty blockers in an improper manner are complicit in the abuse. As are prescription drug manufacturers, which is the basis of my investigation."
"Everyone involved in damaging our young people like this must be held accountable and brought to justice, and that's exactly what I'm doing," Paxton added.
In a statement to Fox News, a spokesperson for Endo Pharmaceuticals denied promoting the usage of these drugs for gender dysphoria.
"Endo Pharmaceuticals Inc. manufactures and markets Supprelin LA for the treatment of children with central precocious puberty (CPP)," Heather Zoumas Lubeski, a spokeswoman for the company, told Fox News. "Vantas, indicated for the palliative treatment of advanced prostate cancer, was discontinued due to manufacturing issues and has not been a promoted product for more than five years."
"The company has not promoted either of these medications outside of their indications and does not promote medications for off-label uses," she added. "That being said, we intend to fully cooperate with this inquiry/investigation."
"We do not have any approved medications indicated for gender dysphoria and we do not promote medications for off-label uses," she continued.
Dr Michael Laidlaw, a California endocrinologist, explained the drugs' original usages and the potentially lifelong side effects these drugs can have when not used for its originally intended purposes.
"I agree with AG Paxton that these drugs are only FDA approved as puberty blockers in children for the purpose of treating central precocious puberty and not for gender dysphoria," Laidlaw told Fox News.
"Central precocious puberty is a medical condition in which a child starts puberty at an abnormally young age, say age 4," Laidlaw said. "Medications like Supprelin LA are used to stop this abnormal puberty. Then once the child reaches a typical age for puberty (say age 11 or 12), the medication is stopped, and then normal puberty will resume."
"The off-label use of these medications for gender dysphoria is completely different," he added. "In this case the healthy child has already begun normal puberty. But then the medication is given to block normal puberty."
"Blocking normal puberty has numerous unhealthy side effects including loss of normal bone development, interference with normal brain and social development, and importantly causes infertility and sexual dysfunction. Many of these effects will be irreversible," he continued.
Laidlaw also noted that these medications are "very expensive," with the procedure to implant Supprellin LA, which slowly releases the medication subcutaneously over around one year, runs around $44,973.