A Georgia woman blames a controversial drug for ruining her life and the lives of thousands of other women. Her federal lawsuit claims several pharmaceutical companies failed to warn her and others about crippling side effects.
The drug Lupron was originally approved for prostate cancer, but for the last 20 years women have taken it to relieve pelvic pain. Terry Paulsen’s case alleging negligence and product liability is being watched closely by patients both male and female who now consider themselves Lupron victims.
Paulsen lives in Lexington, Ga., east of Athens. She is not yet 60, but she looks closer to 80.
“My body is on fire,” Paulsen told Channel 2 Action News. “My joints have arthritis everywhere.”
In another life, Paulsen was a neo-natal emergency nurse and avid equestrian. For her interview with Channel 2, Paulsen needed a recliner. She has endured multiple surgeries, mysterious rashes and constant pain over a 14-year period.
“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.
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.
Jim Strickland is the consumer investigator at Channel 2 Action News. Sheila Schutt is an investigative producer at Channel 2.