文档介绍：*** Warning ***
October 13, 2010, the . Food and Drug Administration (FDA) reported that it is updating the
public regarding information municated describing the risk of atypical fractures
of the thigh, known as subtrochanteric and diaphyseal femur fractures, in patients who take
bisphosphonates for osteoporosis. This information will be added to the Warnings and
Precautions section of the labels approved to treat osteoporosis, including Fosamax, Fosamax
Plus D, Actonel, Actonel with Calcium, Boniva, Atelvia, and Reclast (and their generic
products). A Medication Guide will also be required to be given to patients when they pick up
their bisphosphonate prescription.
BACKGROUND: Atypical subtrochanteric femur fractures are fractures in the bone just below
the hip joint. Diaphyseal femur fractures occur in the long part of the thigh bone. These
fractures are very mon and appear to account for less than 1% of all hip and femur
fractures overall. Although it is not clear if bisphosphonates are the cause, these unusual
femur fractures have been predominantly reported in patients taking bisphosphonates.
MENDATIONS: Patients should continue to take their medication unless told to stop
by their healthcare professional. FDA mends that healthcare professionals should
discontinue potent antiresorptive medications (including bisphosphonates) in patients who
have evidence of a femoral shaft fracture. See the FDA Drug munication below for
additional information.
*** Safety Alert ***
Possible increased risk of fractures of the hip, wrist,
and spine with the use of proton pump inhibitors
The . Food and Drug Administration (FDA) is revising the prescription and over-
the-counter (OTC) labels for a class of drugs called proton pump inhibitors to
include new safety information about a possible increased risk of fractures of the
hip, wrist, and spine with the use of these medications.
Proton pump inhibitors