To add to your posts, here's an article excerpt on how it's working out for girls treated with lupron for precocious puberty: not well.
extract
For years, Sharissa Derricott, 30, had no idea why her body seemed to be failing. At 21, a surgeon replaced her deteriorated jaw joint. She’s been diagnosed with degenerative disc disease and fibromyalgia, a chronic pain condition. Her teeth are shedding enamel and cracking.
None of it made sense to her until she discovered a community of women online who describe similar symptoms and have one thing in common: All had taken a drug called Lupron.
Thousands of parents chose to inject their daughters with the drug, which was approved to shut down puberty in young girls but also is commonly used off-label to help short kids grow taller.
The drug’s pediatric version comes with few warnings about long-term side effects. It is also used in adults to fight prostate cancer or relieve uterine pain and the Food and Drug Administration has warnings on the drug’s adult labels about a variety of side effects.
More than 10,000 adverse event reports filed with the FDA reflect the experiences of women who’ve taken Lupron. The reports describe everything from brittle bones to faulty joints.
In interviews and in online forums, women who took the drug as young girls or initiated a daughter’s treatment described harsh side effects that have been well-documented in adults.
Women who used Lupron a decade or more ago to delay puberty or grow taller described the short-term side effects listed on the pediatric label: pain at the injection site, mood swings, and headaches. Yet they also described conditions that usually affect people much later in life. A 20-year-old from South Carolina was diagnosed with osteopenia, a thinning of the bones, while a 25-year-old from Pennsylvania has osteoporosis and a cracked spine. A 26-year-old in Massachusetts needed a total hip replacement. A 25-year-old in Wisconsin, like Derricott, has chronic pain and degenerative disc disease.
“It just feels like I’m being punished for basically being experimented on when I was a child,” said Derricott, of Lawton, Okla. “I’d hate for a child to be put on Lupron, get to my age and go through the things I have been through.”
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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?”
Link in next post.