I'm sure you're on the edge of your seats, waiting for the next part.
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In 2009, an international consortium of pediatricians had warned against such use. Among them was a pediatric endocrinologist, Dr. Erica Eugster, whose research found that puberty-delaying drugs are widely used off label, even though the safety of such prescribing is unproven.
The health problems described by more than a dozen women in interviews could illustrate long-range effects of pediatric use and warrant further investigation.
“That’s what you have to ask, ‘Is this the tide rising?’” said Dr. Alan Rogol, a University of Virginia Medical School professor emeritus in pediatrics who said he prescribed the medication for decades. “None of us can answer that.”
AbbVie Inc., the company that now makes the drug, said Lupron safety studies were submitted to the FDA before it approved the medication for Central Precocious Puberty in 1993. The drug’s label defines the condition as the onset of sexual characteristics before age 8 in girls and before 9 in boys.
“Uses beyond those contained in the approved label are considered unapproved uses,” company spokesman Morry Smulevitz said in an email.
Federal records show that the FDA official who led the drug approval process two decades ago was troubled by the two studies he reviewed. In a 1993 letter obtained under the Freedom of Information Act, former FDA medical officer Dr. Alexander Fleming wrote in a memo for the drug approval file that it was “regrettable” that the panel approved the drug after minimal study.
One study followed 22 children for just six months, Fleming said. He described the other study as a “free for all” review that made it difficult to determine what dose was best for children of different sizes. Still, he suggested long-term tracking of the drugs’ effects and favored approval “in the absence of any better approach.”
The study Fleming referred to as the “free for all” concluded in 1992, according to a summary submitted to European authorities. Fleming had no further comment when contacted recently.
A different drugmaker-sponsored study, completed long after Fleming’s letter, looked at children who had taken Lupron for precocious puberty from 1991 to 2009. The 2010 study, which was submitted to the FDA, reported that seven of 55 kids had suffered serious side effects, but said the only serious side effects possibly related to Lupron were the growth of a preexisting tumor, deteriorating vision, and severe asthma exacerbation.
According to the National Institutes of Health repository of clinical research, which lists adverse effects discovered in studies, there are two serious side effects of Lupron that aren’t mentioned in the drugmaker’s 2010 study: a bone disorder and a disease-caused fracture, an omission which looks “puzzling” to Dr. Ned Feder, a staff scientist at the Project on Government Oversight.
“It does seem to me that that is certainly a point of criticism,” Feder said. “What are they doing? Is this an accident?”
Smulevitz and the author, Dr. Peter A. Lee of the Penn State College of Medicine, did not answer specific questions about the report. The 2010 study Lee wrote was sponsored by Abbott Laboratories, and is not published in a peer-reviewed journal.
Abbott, which was once part of a joint venture that made Lupron, said in a statement that Lupron and the rest of its pharmaceutical business were transferred to AbbVie in 2013.
AbbVie paid the author, Dr. Lee, $157,066 from 2013 through 2015 for traveling and speaking about Lupron across the nation, according to publicly available Medicare data. Lee did not respond to questions about his financial relationship with the drug company.
Smulevitz, the company spokesman, said AbbVie “regularly monitors and reports to [the] FDA (as well as other regulatory agencies) new safety information on an ongoing basis to ensure that our label contains accurate and up-to-date information to assist prescribers and patients.” He said prescribers are referred to other Lupron warning labels to review adverse events.
The FDA, in its statement, said it continues to review post-marketing reports of Lupron and other drugs in its class, monitors adverse-event reports, and informs the public of safety concerns.
This article was written in 2017. Since then, the American FDA has recorded pseudo-tumours as a side-effect of Lupron when taken by children. That was in 2022, I think.