FDA biphosphonate alert
October 14, 2010
THE US Food and Drug
Administration has overnight issued
a warning about possible increased
risks of thigh bone fractures in
patients taking biphosponates.
The FDA has mandated new
labelling changes warning about
the possible risks of long term use
of the osteoporosis drugs.
Medications covered by the
warning include oral
biphosphonates indicated for
osteoporosis including Fosamax,
Fosamax Plus D, Actonel, Actonel
with Calcium, Boniva, Atelvia and
their generic equivalents.
The FDA is also warning about
injectable biphosphonates such as
Reclast and Boniva, but labelling
changes won’t apply to
biphosphonates used for Paget’s
disease such as Didronel, Zometa
and Skelid.
The warning follows a Drug
Safety Communication issued by
the FDA in March which announced
an ongoing safety review of
biphosphonate use and the
occurrence of atypical femur fractures.
The FDA says it’s since reviewed
all available data including a key
report from a task force at the
American Society for Bone Mineral
Research which recommended
“additional labelling, better
identification and tracking of
patients experiencing these breaks,
and more research to determine
whether and how these drugs cause
the serious but uncommon fractures”.
Based on the FDA review the
Warnings and Precautions section
of all biphosphonate products for
osteoporosis will be revised, and the
agency has also ordered the
inclusion of a Medication Guide “to
better inform patients of the
possible increased fracture risk”.
However the FDA added that
patients taking biphosphonates for
osteoporosis should not stop using
their medication unless advised to
by their health professional.
“Those taking biphosphonates
should also report any new thigh or
groin pain to their health care
provider and be evaluated for a
possible femur fracture,” the FDA
alert added.
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