FDA Advisers Call for Revised Labels for Osteoporosis
FRIDAY, Sept. 9 (HealthDay News) -- U.S. Food and Drug
Administration advisers recommended Friday that osteoporosis drugs
such as Fosamax, Actonel, Boniva and Reclast come with revised
labels, clarifying how long a patient should take a drug before
potential health risks set in.
The drugs, known as bisphosphonates, are taken to prevent
fractures related to postmenopausal osteoporosis. But researchers
have linked long-term use with a small risk of unusual fractures of
the thigh bone, death of the jawbone (osteonecrosis of the jaw) and
possibly esophageal cancer.
By a 17-6 vote, the FDA advisers recommended that the drug
labels -- or package inserts -- should be clarified, detailing the
best duration of use for each drug. But the advisers did not offer
specific wording changes; the label wording could vary for each
Associated Press reported.
The revised labels should "be very clear that efficacy may fall
off after a period of time, perhaps five years," panelist Dr. Lewis
Nelson, director of the medical toxicology fellowship program at
New York University, said after the vote,
Bloomberg News reported. "Serious concerns have been raised
about risk, and those need to be continually evaluated as
The FDA is not compelled to follow the recommendations of its
advisory committees but it usually does so.
According to the FDA, in 2009 more than 5 million prescriptions
were filled for bisphosphonates, which inhibit bone loss.
Dr. Elizabeth Shane, past president of the American Society for
Bone and Mineral Research, who was scheduled to testify before the
committee, said reports linking bisphosphonates with atypical
fractures and osteonecrosis of the jaw are "extremely rare, when
considered in the context of how many people take bisphosphonates
for osteoporosis." She was "less certain about the esophageal
cancer issue," she added.
While these side effects shouldn't be downplayed, "when you
consider the number of very dangerous, life-threatening fractures
that are prevented by these drugs, the benefits dwarf the side
effects," said Shane, also a professor of medicine at Columbia
University in New York City.
However, she said bisphosphonates should only be prescribed to
those at the highest risk of fracture. "In the past we might have
used them in people who aren't at such high risk of fracture in the
hope that they would prevent fractures down the line," she said.
"We have moved to targeting people at high short-term risk, which
means in the next five to 10 years."
According to Shane, the absolute risk of developing
osteonecrosis of the jaw is between 1 in 10,000 and 1 in 400,000
among people taking these drugs for osteoporosis.
But when high-dose bisphosphonates are used to slow the spread
of bone cancer, the risk rises, affecting anywhere from 1 percent
to 15 percent of patients, she said.
For atypical femur (thigh) fractures, the absolute risk linked
to bisphosphonates is about 1 to 5 fractures in 10,000
bisphosphonate users, she said.
Besides hip fractures, bisphosphonates prevent spine, wrist and
arm fractures, Shane said.
The FDA asked the advisory committee to consider whether current
data support long-term use of bisphosphonates for treating or
preventing osteoporosis. The experts also were to consider whether
a time limit should be placed on the drugs' use, and if patients
who need long-term therapy would benefit from a "drug holiday,"
meaning time off the medication.
"I am really not in favor of putting a limit on use of bisphosphonates and dictating the use of drug holidays," Shane said. "We have very little evidence to support the use of drug holidays or no drug holidays."
Dr. Nelson Watts, director of the University of Cincinnati Bone
Health and Osteoporosis Center and co-author of a 2010 study on
long-term use of bisphosphonates, said length of treatment should
be considered on an individual basis. His study suggested patients
at mild risk might discontinue drug treatment after five years for
as long as no fractures occurred and no bone loss was evident.
Higher-risk patients could take the drugs for 10 years and perhaps
then take a "holiday" from bisphosphonates of one or two years.
"It would probably be helpful if FDA or some official organization could provide guidelines on duration of treatment, details of drug holidays, etc., but there is probably not enough information in the literature for recommendations based on science," Watts said before Friday's vote.
Common bisphosphonates are taken in tablet form or by injection.
They include: Fosamax (alendronate sodium) made by Merck & Co.,
Inc.; Actonel and Atelvia (risedronate sodium) made by Warner
Chilcott; Boniva (ibandronate sodium) from Roche Therapeutics,
Inc.; and Reclast (zoledronic acid) from Novartis Pharmaceuticals
For more information on osteoporosis, visit the
U.S. National Library of Medicine.
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