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FOSAMAX: IS LONG TERM USE OF BONE STRENGTHENING DRUG LINKED TO FRACTURES?

A popular class of osteoporosis drugs may have opposite effect, experts say.

ByABC News
March 8, 2010, 10:15 AM




March 9, 2010&#151; -- Sandy Potter, 59 of Queens, New York, was jumping rope
with neighborhood children when she felt her thigh bone snap.



"I went up in the air and I came straight down to the ground," Potter said. "The
pain was excruciating."



Potter, who was diagnosed with osteoporosis at age 48, had been taking the
popular osteoporosis drug Fosamax for eight years before her femur literally
snapped in two.





Fosamax, one in a class of drugs called bisphosphonates, is supposed to make
bones stronger. But now there's mounting evidence that for some women, taking
Fosamax or its generic alendronate for more than five years could cause
spontaneous fractures.



"We are seeing people just walking, walking down the steps, patients who are
doing low-energy exercise," said Dr. Kenneth Egol, professor of orthopedic
surgery at NYU Langone Medical Center. "Very unusual, the femur is one of the
strongest bones in the body."





Egol said X-rays of some of his patients look more like an injury endured by a
car accident than an otherwise minimal fall.



"Over the last 18 months we are seeing this more frequently," he said.



Sue Heller, 60, of Castle Rock, Colo., had been on Fosamax for almost 10 years.
She broke both of her femur bones.





"I'm sure there are a lot of women who have brittle bones right now that maybe
are ready to break, and they're not aware of it," said Heller. "And my heart
aches for them."

Sales of the popular drug increased when doctors began prescribing it not only
to women showing signs of osteoporosis, but also those who were osteopenic, and
thus, at risk for the disease. Now some doctors worry that staying on the drug
for more than five years can cause some women's bones to become more brittle.









This is not the first time that many doctors have reported an opposite effect
for many people taking the drug. Fosamax has already been linked to severe
musculoskeletal pain, as well as to a serious bone-related jaw disease called
osteonecrosis.



"In worldwide post-marketing experience with FOSAMAX/FOSAMAX Plus D, rare
reports consistent with osteonecrosis of the jaw have been received. Many of
these reports lack sufficient clinical details to make definitive assessments
and/or are confounded, particularly since a generally accepted definition of ONJ
in the general population is unknown," responded Merck in a written response to
the suggested link. "Rare cases of ONJ have also been reported in patients who
do not have osteoporosis and who have not taken any bisphosphonate medicines."

In 2008, the Food and Drug Administration reached out to the pharmaceutical
company Merck about the reports of femur fractures. After 16 months, Merck added
patients' reports of femur fractures to the list of possible side effects
reported by patients included in the drug's package insert.



"It took Merck an entire year to respond," said ABC News senior health and
medical editor, Dr. Richard Besser. "Just six words: 'low energy femoral shaft
and subtrochanteric fractures.'"



The FDA has also never made an effort to inform the public or doctors across the
country who prescribe bisphosphonates of the possible side effect, said Besser.



Both the FDA and Merck declined ABC News' request for an interview. The FDA said
they are looking into reports of fractures.



"Nothing is more important to Merck than the safety of its medicines," according
to a written statement by Merck to ABC News. A causal relationship between
Fosamax and these fractures has not been established, according to Merck.



"The drug companies have to recognize when there is a problem, they have to be
up front with the public. If there's a concern, they have to voice it and at
least give everybody a fair chance to look at this carefully," said Dr. Joseph
Lane, orthopedic trauma surgeon at the Hospital for Special Surgery in New York
City.



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