“Since I got Lupron in 2004, we did not know this was coming,” said Paulsen.
Lupron is an injection. It stops the production of sex hormones. Paulsen had only two shots to treat her endometriosis, painful lesions of uterine-like tissue that feed on estrogen.
“And this drug needs to have a black box warning on it, because I know what it did to me,” said Paulsen.
At the time, the Lupron label cautioned about “…a loss in bone density. But for a period of up to six months, this bone loss should not be clinically significant.” The current label drops that claim.
“Her immune system began to attack her own bones. She got osteopenia and osteoporosis and now she’s got terrible osteoporosis,” said Dr. Alan Levin, an immunologist with 50 years of experience, including consulting with the FDA, who is also Paulsen’s lawyer.
Terry Paulsen is from Lexington, Ga., east of Athens. She blames a drug used to treat pelvic pain for painful side effects and has sued the drug maker in a case being watched by thousands of others who have taken the drug. She was a skier and an equestrian when she was young but now experiences too much pain to be active. WSB-TV
Levin said he believes thousands of others suffer similar symptoms.
Lupron users have filed nearly 24,000 reports of adverse reactions with the FDA; 60 percent of those were filed by women, Channel 2 found. The FDA deemed more than half of them serious cases.
“It feels like I have 80-year-old bones,” said 22-year-old Brooklyn Harbin. She’s one of the people who filed an adverse reaction report. She had been an active and athletic 10-year-old. But she began her period too early. A doctor prescribed Lupron for Harbin to halt early puberty.
“The back pain became very, very severe. It got very, very depressing having to be in a wheelchair in the fifth grade,” said Harbin.
“I feel that Lupron or any of the similar types of medications should never be used in someone under the age of 21,” said Dunwoody gynecologist Dr. Ken Sinervo. He specializes in endometriosis surgery. He told Channel 2 he’s seen many women suffering memory loss and joint pain.
Channel 2 emailed Lupron’s maker to ask why there is no warning on the box about memory loss or joint pain. The pharmaceutical company declined to go on camera but responded with a statement: “AbbVie regularly monitors and reports to appropriate regulatory agencies new safety information on an ongoing basis to ensure that our label contains accurate and up-to-date information to assist physicians and patients.”
Lupron lawyers convinced a federal judge to seal the results from several clinical trials, but not before an expert witness disclosed evidence that even after a year off the drug, 62 percent of women did not regain normal estrogen levels. AbbVie refused to comment on the studies or on Terry Paulsen.
“There is not a dime that can pay for what I have lost,” said Paulsen.
<em>Jim Strickland is the consumer investigator at Channel 2 Action News. Sheila Schutt is an investigative producer at Channel 2.</em>