Osteonecrosis of the Jaw
The
National Osteoporosis Foundation's Scientific Statement about Osteonecrosis of
the Jaw (ONJ) published June 14, 2006 follows:
What
is Osteonecrosis of the Jaw?
Recently
reports have described a dental condition, ONJ, in which bone in
the lower jaw or less commonly the upper jaw becomes exposed, typically
after a dental extraction or some other trauma to the jaw, and the
wound that occurs fails to heal in the usual time frame. Infection
in the area can occur and the area may be painful. This can become
a chronic problem in many of those who develop it. With careful dental
management, use of antibiotics and daily rinsing of the mouth with
antibiotic solutions some patients with the condition do experience
healing over time.
Current
information suggests that this condition appears to occur infrequently
in patients with cancer and rarely in patients with benign conditions
such as osteoporosis or Paget’s disease of bone who are being
treated with bisphosphonate medications.
Of
the cases reported to date, nearly 95% were cancer patients receiving
an intravenous bisphosphonate, pamidronate (Aredia®)
or zoledronate (Zometa®), typically
given every three to four weeks. A very small number of patients
being treated with the bisphosphonate pills alendronate (Fosamax®)
or risedronate (Actonel®)
for osteoporosis prevention or treatment have also been reported
to have developed ONJ. Fosamax® and
Actonel® have
been available in the U.S. since 1995 and 1998, respectively, and
have been used safely by many millions of patients.
Last
year, the U.S. Food and Drug Administration (FDA) decided that a statement
about ONJ would be required in the safety information provided in
the package inserts of all bisphosphonate products so that health care providers
and patients would have this information.
What
are points to consider?
Whenever
a medication is prescribed, it is important for the patient to understand
both the benefits and the potential risks or side effects associated
with that medication.
Fosamax® and
Actonel® were approved
by the FDA for use in the prevention and treatment of osteoporosis
after extensive clinical studies found them to be generally well
tolerated and effective in reducing bone loss to prevent osteoporosis
and in reducing the likelihood of fractures in patients with osteoporosis.
Based
on information available to date, the incidence of ONJ appears to
be rare in people taking oral bisphosphonates. It is important however,
that patients taking bisphosphonates continue to get regular dental
check-ups and to let their dentist know about all the medications
they take.
There
are reports that some dentists are advising patients to stop the
use of bisphosphonates for a period of time (e.g. a month or two)
before and after a tooth extraction or implant surgery, but there
is no clear evidence, at this time, as to whether this is
necessary.
Summary
Based
on the currently available information, NOF believes that the benefits
of oral bisphosphonate medications outweigh the potential risk of
ONJ in the vast majority of patients who are receiving them. Without
these medications, patients for whom they are appropriate treatment
would be at higher risk of fractures, and fractures are the source
of significant pain and disability that impact on function and quality
of life.
NOF
encourages all osteoporosis patients taking oral bisphosphonates
to discuss their individual situation with their doctor or other
health care provider. As clinical information is still incomplete
and the causes not fully understood, research into ONJ continues.
As new information becomes available, NOF will be providing updates.
Reference:
Woo
SB, Hellstein JW, Kalmar JR. Systematic review: bisphosphonates and
osteonecrosis of the jaws. Annals of Internal Medicine.
2006 May 16;144(10):753-61.
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