First in a two part series
happened to Susan Hayward while taking a drug called Lupron for a
gynecological problem. She started losing her memory.
That was in 1992, when Hayward was 36.
the next five years, Hayward, a healthy, active postal worker, was
given 18 more injections of the drug. Other curious health problems
followed. She developed herniated discs, her body ached all over, and
her memory worsened.
Two years after she stopped
taking the drug, Hayward, now 43 and living in Carver, is on disability
and has trouble remembering basic things, like conversations she had
earlier in the day. She suspects Lupron triggered irreversible changes
in her brain.
"I went to college and I feel like I
am an idiot now, because I can't remember anything," Hayward said.
"There has to be some connection."
Hayward is hardly alone.
of women nationwide have reported to federal health officials serious
side effects from Lupron, a drug originally developed to treat men with
advanced prostate cancer but now widely used to treat women for a
variety of routine gynecological problems.
serious side effects reported by women include tremors, seizures,
memory loss and joint pain. The problem is, some women say these side
effects are not going away - even after they stop taking the drug.
manufacturer insists its product is safe. The Food and Drug
Administration, the federal agency that approves drugs for public use,
says the benefits from Lupron outweigh the risks.
a growing number of women, women's health advocates and medical
ethicists question that, saying the potent drug designed for men who
have few other treatment options for advanced prostate cancer is being
widely used on young, healthy women - without enough studies to show
whether it causes long-term, and possibly irreversible, side effects.
is something that sends a substantial number of women into a tailspin,"
said Judy Norsigian, program director for the Boston Women's Health
Book Collective, a co-author of "Our Bodies, Ourselves." "It's one of
the drugs that we feel has not been adequately assessed."
this worry, dozens of interviews of women and medical experts by the
Sunday Herald indicate Lupron is commonly used by doctors, including
specialists who prescribe it for treatment of infertility in women.
FDA has never OK'd Lupron for infertility treatments. And medical
experts and women's advocates say not enough studies have been done to
show whether Lupron is safe or effective for that use.
the FDA allows Lupron to be used for infertility treatments because
under federal law, once a drug is approved for one use, doctors can
prescribe it for any use.
"I have used Lupron (on
infertility patients) for as long as it's been available," said Dr.
Richard Reindollar, director of the division of Reproductive
Endocrinology at Beth Israel Deaconess Medical Center. Reindollar also
holds a similar position at Boston IVF, one of the region's
highest-volume infertility clinics.
patients do not like the side effects of Lupron, I do not remember one
patient with such an extreme reaction requiring her to stop the
medication," Reindollar said.
Lupron, which is
given by injection, was first approved by the FDA in 1985 solely for
treatment of men with advanced prostate cancer. The drug is made by
Deerfield, Ill.-based TAP Pharmaceuticals Inc., which is a joint
venture of Abbott Laboratories and Takeda Chemical Industries, Japan's
largest drug company.
By 1989, a year before the
FDA granted TAP permission to market the drug for limited use in women,
TAP was aggressively promoting Lupron to obstetricians and
gynecologists, FDA records show.
The FDA warned TAP
in a March 1990 letter that, "Your firm has undertaken a deliberate
campaign to promote this product for a wide range of unapproved uses."
The letter warned the company to stop such promotions, especially the
distribution of brochures targeted at consumers.
claim that Lupron is safe and effective, and actively promote its
administration in a range of indications for which Lupron is not
approved and apparently has not been adequately demonstrated to be safe
and effective," the letter noted.
its review of the drug, the FDA approved Lupron in October 1990 for
limited use in women, for the treatment of endometriosis. In 1995, the
FDA OK'd the drug for treatment of uterine fibroids.
To date, the FDA reports 6,272 complaints filed for adverse side-effects from Lupron - 553 have come within the past 20 months.
the past two years roughly 2 million prescriptions were written for
Lupron in the United States, according to IMS Health, a Pennsylvania
company that tracks prescription drugs.
The FDA's records also include 25 women's deaths where Lupron was listed among the suspected, but not proven, causes.
number of suspected problems could be even larger, because the FDA
itself says such "adverse events" are generally underreported. The
agency notes that 90 percent of adverse reports come from drug
manufacturers, who are required by law to report adverse effects.
Doctors are not required to report bad side effects to the FDA, but may
report them on a voluntary basis, to the FDA or the drug manufacturer.
FDA also says that it has not "scientifically or otherwise verified"
any link between Lupron and the reported adverse effects.
at least one document indicates there is concern within the FDA about
the growing reports of adverse effects from Lupron. In a March 24, 1999
memo, obtained by the Sunday Herald under the Freedom of Information
Act, an FDA epidemiologist who reviewed Lupron reports concluded there
were "high prevalence rates" for serious side effects. She suggested
her agency consider a "re-examination of the product label to ensure
that these events are adequately addressed."
interview, Dr. Marianne Mann, the FDA's deputy director for the
Division of Reproductive and Urologic Drug Products, said her
department did review its data after that report and decided no
additional action was needed.
reviewed this data and reviewed the Lupron (package warnings) and we
feel the current Lupron (warnings) adequately reflects these concerns,"
Like many drugs, Lupron comes with
inserts warning of a number of potentially serious side effects,
including: depression, joint disorders plus loss of bone density, or
Yet none of the warnings - except for bone loss - state the side effects might continue long after stopping use of the drug.
seven of the women interviewed for this story say they suffered memory
loss and bone aches while on Lupron, and that the problems continue
years after stopping the drug. Some say seizures and serious vision
problems that started while on Lupron also haven't gone away.
woman, Linda Abend in southern New Jersey, started a National Lupron
Victims Network after her 34-year-old sister was hospitalized with
seizures while taking Lupron in 1991 for a benign fibroid. Abend says
her sister continues to suffer daily seizures, plus debilitating bone
and muscle pain eight years later. And Abend said she has heard from
more than 1,000 people nationwide - mostly women - who also report
serious side effects that continue after stopping Lupron.
The FDA says it has not tracked claims of such long-term effects.
post-marketing system works on getting information from these adverse
events," Mann said. "We accumulate data over time, and it takes a while
to get this data. At present we feel the label adequately addresses
But University of Pennsylvania
bioethicist Glenn McGee, who specializes in reproductive issues, says
the FDA is making a mistake.
"We just don't know
yet what Lupron causes," McGee said, "but there is enough evidence that
something is wrong and that the FDA should initiate studies."
Despite the mysterious health problems some link to Lupron, others swear by the drug.
Hamelburg, of Braintree, says Lupron saved his life. Hamelburg, 59,
started taking Lupron in 1992, when he was diagnosed with advanced
prostate cancer and given a bleak prognosis.
said he believes his cancer is in remission because of Lupron. But, he
said, he stopped taking Lupron this May because he was diagnosed with
osteoporosis, which he believes was caused by Lupron.
was a wonder drug, but it was costly," Hamelburg said. "I have hot
flashes, loss of libido, I've gained weight, I'm over 300 pounds, my
breasts are enlarged. I can live with these. They are a pain in the
neck, but they are livable."
In a statement, TAP
Pharmaceuticals said it has "compassion" for the long-term side effects
a growing number of women have complained about. The company also said
its product is safe and has helped many patients.
Lupron's approval, which was nearly 10 years ago, hundreds of thousands
of endometriosis and uterine fibroid sufferers have used Lupron safely,
and Lupron has not been found to have any irreversible or lasting side
effects," said TAP's Kim Modory.
Yet the case of Victoria Lee Burns in Maryland raises questions about that claim.
1991, Burns, who was in her 20s and working in a bank, took five
monthly injections of Lupron for endometriosis and ended up
hospitalized for severe arthritis-like symptoms, according to her
lawyer, Nicole Schultheis.
"Contrary to what was
stated in the literature, her symptoms were not reversible upon
cessation of therapy," Schultheis said, adding that her client remains
permanently disabled from Lupron, and struggles daily with walking,
driving and standing.
Burns sued TAP Pharmaceuticals in 1994.
"They refused to produce documents until I agreed I would keep them secret and I refused to do that," Schultheis said.
In January 1997, TAP settled the case. The terms of the settlement are secret.
TOMORROW: Women who have taken Lupron, and their campaign to get an investigation of the drug.
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