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Bisphosphonates and Reports of Bone,
Joint and/or Muscle Pain
January 24, 2008 /
Reviewed and approved by the Science and
Research Committee of the NOF Board of
Trustees.
What is the concern?
On January 7, 2008, the Food and Drug
Administration (FDA) informed physicians
about the possibility of an adverse
event reported in some patients taking
bisphosphonates. There have been rare
reports of bone, joint and/or muscle
pain, sometimes very severe, occurring
within days, months, or even years after
starting one of the bisphosphonates (Fosamax®,
Actonel®, Boniva®, and Reclast®) for
osteoporosis. The FDA issued this notice
in order to provide information to
physicians and healthcare practitioners
to help them manage their patients who
experience these symptoms.
In nearly all reported cases, pain is
relieved when the bisphosphonate therapy
stops. Discomfort resolves within a few
days after the drug is stopped, but may
last as long as a week and in rare
cases, much longer. In a few cases, when
the bisphosphonate therapy restarts, the
pain returns. The pain is quite severe
and should not to be confused with the
many aches and pains suffered by people
that come and go during life.
What do we know?
What we know is that this problem is
uncommon and most osteoporosis
specialists have seen no more than one
or two cases despite clinical use of
this class of drugs for more than 15
years.. No reports of this condition
surfaced during the clinical trials of
bisphosphonates, which preceded FDA
approval. Bisphosphonates are the
mainstay of treatment and prevention of
osteoporotic fractures, with as many as
191 million prescriptions written
(Source: MS HEALTH, NPA Plus™ May 2006).
Presently, there is no known method to
distinguish between these symptoms and
other causes of pain in patients with
osteoporosis. Physicians should
recognize this set of symptoms, and if
it occurs, first stop the bisphosphonate
and evaluate to see if the pain eases
before ordering expensive and
uncomfortable evaluations. Physicians
should not consider this syndrome as a
contraindication to beginning treatment
of osteoporosis with bisphosphonates.
However, if severe bone pain occurs in
patients taking bisphosphonates, the
drug should be stopped for a period to
evaluate the response. NOF believes the
benefits of bisphosphonate treatment in
patients at risk of osteoporotic
fracture strongly outweigh the risks
from treatment. Serious long-term
disability and death are significant
consequences of osteoporotic fractures.
Summary
The FDA continues to study the problem
and will have further reports as time
passes. Until more is known, NOF advises
the following:
Patients who take bisphosphonates should
report severe and long lasting pain to
their physician and discuss whether
treatment should be stopped.
Patients should discuss their
medication concerns with their
healthcare providers.
Physicians of patients who report
severe and long lasting bone pain while
on bisphosphonates should discontinue
bisphosphonates for a period of time
until the pain symptoms resolve. Other
FDA-approved forms of treatment for the
osteoporosis can then be considered.
References
U.S. Food and Drug Administration. FDA
Alert: Information for Healthcare
Professionals: Bisphosphonates (marketed
as Actonel, Actonel+Ca, Aredia, Boniva,
Didronel, Fosamax, Fosamax+D, Reclast,
Skelid, and Zometa). January 7, 2008.
Online at:
http://www.fda.gov/medwatch/safety/2008/safety08.htm#Bisphosphonates.
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