FDA: Possible increased risk of thigh bone fracture with bisphosphonates

FDA: Possible increased risk of thigh bone fracture with bisphosphonates
Labeling change adds warning about possible risks of long-term use of
osteoporosis drugs

The U.S. Food and Drug Administration today warned patients and health
care providers about the possible risk of atypical thigh bone
(femoral) fracture in patients who take bisphosphonates, a class of
drugs used to prevent and treat osteoporosis. A labeling change and
Medication Guide will reflect this risk.

Bisphosphonates inhibit the loss of bone mass in people with
osteoporosis. Bisphosphonates have been shown to reduce the rate of
osteoporotic fractures -- fractures that can result in pain,
hospitalization, and surgery-- in people with osteoporosis. While it
is not clear whether bisphosphonates are the cause, atypical femur
fractures, a rare but serious type of thigh bone fracture, have been
predominantly reported in patients taking bisphosphonates. The optimal
duration of bisphosphonate use for osteoporosis is unknown, and the
FDA is highlighting this uncertainty because these fractures may be
related to use of bisphosphonates for longer than five years.

The labeling changes and Medication Guide will affect only those
bisphosphonates approved for osteoporosis, including oral
bisphosphonates such as Fosamax, Fosamax Plus D, Actonel, Actonel with
Calcium, Boniva, Atelvia, and their generic products, as well as
injectable bisphosphonates such as Reclast and Boniva.

Labeling changes and the Medication Guide will not apply to
bisphosphonates used for Paget's disease or cancer/hypercalcemia such
as Didronel, Zometa, Skelid, and their generic products.

"The FDA is continuing to evaluate data about the safety and
effectiveness of bisphosphonates when used long-term for osteoporosis
treatment," said RADM Sandra Kweder, M.D., deputy director, Office of
New Drugs in the FDA's Center for Drug Evaluation and Research. "In
the interim, it's important for patients and health care professionals
to have all the safety information available when determining the best
course of treatment for osteoporosis."

Today's warning follows a March 10, 2010, Drug Safety Communication
announcing the FDA's ongoing safety review of bisphosphonate use and
the occurrence of atypical femur fractures. The FDA has since reviewed
all available data on bisphosphonate use, including data summarized in
the American Society for Bone Mineral Research Task Force report. The
report recommended additional product labeling, 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's review, the Warnings and Precautions section of all
bisphosphonate products for osteoporosis will be revised, and the FDA
will require the inclusion of a Medication Guide to better inform
patients of the possible increased fracture risk.

The FDA recommends that health care professionals be aware of the
possible risk in patients taking bisphosphonates and consider periodic
reevaluation of the need for continued bisphosphonate therapy for
patients who have been on bisphosphonates for longer than five years.