Bisphosphonates and Reports of Bone, Joint and/or Muscle Pain
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 very rare and is only now coming
to attention after the widespread use of bisphosphonates over the
past 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 for the prevention
and treatment of osteoporosis (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 treatment
of osteoporosis with bisphosphonates. 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 is very significant among patients
who suffer 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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