Derricott was among the first to use Lupron since its discovery in the 1980s, having taken it from the age of five to 12 for the treatment of precocious puberty, even before it was approved for paediatric use.
“It just feels like I’m being punished for basically being experimented on when I was a child,” she said.
Drug approved by FDA “in the absence of any better approach”Lupron is the trade name for leuprorelin, a synthetic hormone under the gonadotropin-releasing hormone (GnRH) analogue family which was initially approved in 1989 for the treatment of prostate cancer, and eventually, for the treatment of uterine fibroids and endometriosis.
In 1993, the Food and Drug Administration (FDA) approved the drug for treatment of central precocious puberty – but federal records revealed that Dr Alexander Fleming, the FDA official who led the approval, found the sanction “regrettable”.
According to Fleming, the panel favoured approval – despite minimal study – only “in the absence of any better approach” and suggested long-term monitoring of the drugs’ effects.
Adverse long term health effects reported with leuprorelin useAs early as 1999, the FDA had examined 6,000 adverse-event reports related leuprorelin use, and a court document stated that it found “high prevalence rates for serious side effects” in both men and women.
The FDA has also received over 20,000 adverse-event reports related to the use of leuprorelin in the past ten years, with approximately 900 reports of children under-13 who suffered from side effects within months of use. Over 10,000 of the reports were from women who described mood swings, headaches, chronic pain, osteopenia and osteoporosis, with some having difficulties in walking, and others – like Derricott – even requiring joint replacements.
Numerous reports as well as studies have emerged throughout the years, highlighting the drug’s long term health effects.
An independent survey conducted by endocrinologist Chandler Marrs found that over 50% of roughly 1,000 women reported moderate to life-threatening depression, many with suicidal thoughts and urges.
“We are currently conducting a specific review of nervous system and psychiatric events in association with the use of GnRH agonists, including Lupron, in pediatric patients,” the FDA also said, adding that there have been reports of fatal seizures from the paediatric use of Lupron.
Off label uses of leuprorelin continue despite warningsThe drug is also costly, with Dr Erica Eugster, a paediatric endocrinologist at the Indiana University School of Medicine, citing a range of $20,000 to $40,000 for two years of treatment. Yet, leuprorelin is still widely prescribed.
According to the FDA approval documents for paediatric Lupron, central precocious puberty affects roughly 2,000 children in the US each year, but 24,000 prescriptions for the drug were written in 2015 alone. In a separate 2015 study, Eugster reviewed records for 260 paediatric patients prescribed with Lupron and similar drugs, only to find that 27% of them did not meet the definition of central precocious puberty.
Her research also revealed that the puberty-delaying drugs were widely used off label, with many health professionals using the drug to help children increase their height and to prepare women for in-vitro fertilisation – even though medical researchers have repeatedly warned against such off label practices due to risks of lifelong health problems.
FDA yet to issue warning over paediatric useDespite numerous adverse-effects reports and studies scrutinising the safety of leuprorelin, the FDA has yet to issue a warning about the potential risks of seizures, bone loss or mood disorders with the drug’s paediatric use, stating that the drug’s impact on children’s bones are “considered ‘unknown’” due to lack of studies.
The agency has said that it will continue to review reports and monitor adverse-events of Lupron and other similar and promises to inform the public of any safety concerns, but in the meantime, patients like Derricott can only wait for a conclusion by the FDA.
“I’d hate for a child to be put on Lupron, get to my age and go through the things I have been through,” she said. MIMS
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