Notes

Safety Announcement

[10-13-2010] The U.S. Food and Drug Administration (FDA) is updating the public regarding information previously communicated 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 of all bisphosphonate drugs approved for the prevention or treatment of osteoporosis. Bisphosphonates are a class of medicines that can be effective at preventing or slowing the loss of bone mass (osteoporosis) in postmenopausal women, thus reducing the risk of common osteoporotic bone fracture. Osteoporotic fractures can result in pain, hospitalization, and surgery.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 uncommon 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.
The bisphosphonates affected by this notice are only those approved to treat osteoporosis, including Fosamax, Fosamax Plus D, Actonel, Actonel with Calcium, Boniva, Atelvia, and ReclastExternal Link Disclaimer (and their generic products).This notice does not affect bisphosphonate drugs that only are used to treat Paget's disease or high blood calcium levels due to cancer (i.e., Didronel, Zometa, Skelid, and their generic products).
Although the optimal duration of bisphosphonate use for osteoporosis is unknown, these atypical fractures may be related to long-term term bisphosphonate use. FDA will require a new Limitations of Use statement in the Indications and Usage section of the labels for these drugs. This statement will describe the uncertainty of the optimal duration of use of bisphosphonates for the treatment and/or prevention of osteoporosis.
A Medication Guide will also be required to be given to patients when they pick up their bisphosphonate prescription. This Medication Guide will describe the symptoms of atypical femur fracture and recommend that patients notify their healthcare professional if they develop symptoms.
These actions are part of an ongoing safety review of bisphosphonate use and the occurrence of atypical subtrochanteric and diaphyseal femur fractures, as previously announced in a Drug Safety Communication on March 10, 2010.