Second in a two-part series.
Hundreds of women
nationwide, with nowhere else to turn, are forging a campaign against a
drug they believe has ruined their health and their lives.
women charge that Lupron, a drug with few tests for long-term side
effects, has wracked their bones, robbed their memories and damaged
"My knees tremble a lot and get very
weak, and I have to use a cane now to go up and down the stairs," said
Kimberly Savino, 17, of Easton, who was prescribed Lupron last year for
a gynecological problem.
Before taking the drug,
Savino said she often rode horses and jogged. Today, three months after
stopping Lupron, the teenager has trouble even walking and has been
diagnosed with a degenerative arthritis, which usually develops over
Her mother is worried - and suspects Kimberly's strange bone problems were triggered by Lupron.
very hard to see her, all of a sudden, moving around like an old lady
with a cane," said Susan Savino. "Now we don't know if she is going to
end up in a wheelchair. This shouldn't be happening to someone who is
Deerfield, Ill.-based TAP Pharmaceuticals, the
giant drug company that makes Lupron, insists its product is safe. And
federal regulators say no studies have linked Lupron to any of the
long-term debilitating side effects a growing number of women are
Undaunted, many of the women - from
Massachusetts and California to Canada and Florida - have taken to the
Internet (www.delphi.com-afterlupron), organizing a petition they hope
will convince federal regulators to take a closer look. At the very
least, the women say, they want information added to the drug's
packaging, alerting consumers to potential long-term side effects.
The Herald interviewed a dozen of the women, including Kimberly Bradford of Apopka, Fla.
hoping we can show somebody who has influence that there are a lot of
women who this has happened to, and to get them to take a look at what
has happened to us," she said.
Bradford, 31, took
Lupron seven years ago for endometriosis, a common gynecological
disease. Today, she said, she still struggles with vision problems,
dizziness and joint and muscle pain that started while she was on the
Lupron is a potent hormone that was first
approved by the federal Food and Drug Administration in 1985 for men
with advanced prostate cancer who had few treatment options. The drug
more recently has been used widely by doctors to treat women for
various gynecological problems, including infertility.
date, the FDA has logged 6,272 complaints filed for suspected adverse
side effects from Lupron - 553 of those within the past 20 months.
don't want to lose sight of the fact that some patients have a
condition where this might be one of the best treatments available to
them," said the FDA's Dr. Marianne Mann, deputy director of the
division of reproductive and urologic drug products.
the International Endometriosis Association, a nonprofit organization
with 10,000 members, takes the position that Lupron should be available
for women to make their own choices, but warns women the drug may have
potential side effects.
Lupron's packaging, in
highly technical terms, does list several potential, serious side
effects, including memory disorders and depression, but does not say
that any of them - except for a "small loss" of bone mass - may be
Medical experts say loss of bone
mass, typical in older, post-menopausal women, can lead to a variety of
problems, including fractures and joint problems.
of the young women with long-term problems they attribute to Lupron are
reporting a gnawing pain in their bones, and a recent study raises
questions about that issue.
In a report submitted
by TAP Pharmaceuticals to the FDA in April 1998, researchers wrote that
they were "concerned" because more than one-third of the women they
studied who took Lupron did not "demonstrate either partial
reversibility" or "a trend toward return" of bone mass in the six
months after they stopped taking the drug. Further, the researchers
noted some women lost as much as 7.3 percent of their bone density
during treatment - more than twice the amount the drug's packaging
lists in its warnings.
The researchers concluded,
"A more complete assessment of the effects of Lupron on (bone density)
can only be made with longer term follow-up of these patients."
In an interview, the drug's maker, TAP Pharmaceuticals, said its studies show Lupron is safe.
continue to monitor reported side effects through post-marketing
surveillance and continuing research studies," said TAP's Kim Modory.
But in Hyde Park, Sister Regina Rowan is worried.
who has a master's degree in clinical microbiology, is executive
director of the office for responsible investment, for the Medical
Rowan is troubled by the reports of Lupron's growing use by doctors in infertility treatments.
FDA has not approved Lupron for infertility, but it allows drugs the
agency has approved for one use to be prescribed for any other use.
are many side effects with this drug," Rowan said. "It indicates that
this drug has some toxicology in it, and that it should not be used for
Rowan's mission buys stock in
companies and then brings practices by those companies it considers
questionable to shareholder actions. The mission is now focusing on
Lupron's manufacturer, TAP Pharmaceuticals, which is a joint venture of
Abbott Laboratories and Takeda Chemical Industries, Japan's largest
drug company. Rowan's mission owns stock in Abbott.
will be writing to the chairman at Abbott and asking questions about
Lupron," Rowan said. "I will say that I am concerned and ask for a
That's the most promising news Lynne
Millican has heard in a long time. Millican, 42, a registered nurse who
lives in West Roxbury, said she is still battling bone pain and memory
loss she said started 10 years ago when she took Lupron.
"Something happened to my body," Millican said. "I want answers."
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