FDA warns of unusual thigh fracture from use of osteoporosis drugs
October 18th, 2010 by Jennifer Walker-Journey
Widely used osteoporosis drugs designed to prevent bones from breaking may increase the risk of a rare type of thigh fracture, according to the Food and Drug Administration (FDA). The agency notified consumers and health care workers that all bisphosphonates will now carry a new warning about the fractures on their safety labels.
Bisphosphonates, also called diphosphonates, are a class of drugs that prevent the loss of bone mass and are usually prescribed for the treatment of osteoporosis in postmenopausal women to reduce the risk of common osteoporotic bone fracture. The new safety warnings will be on all bisphosphonates such as Fosamax, Fosamax Plus D, Actonel, Actonel with Calcium, Boniva, Atelvia, and Reclast, as well as their generic equivalents.
The warning does not affect bisphosphonate drugs that are only used to treat Paget’s disease or high blood calcium levels due to cancer, such as Didronel, Zometa, Skelid, and their generics.
The new safety label changes include an increased risk of a type of atypical fractures of the thigh known as subtrochanteric and diaphyseal femur fractures. 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 extremely rare fractures account for less than 1 percent of all hip and femur fractures, but are predominately reported in patients taking bisphosphonates.
Bisphosphonates serve an important role in the management of osteoporosis, and the agency says the 5 million or so customers who use the drugs should not stop taking them based on the announcement. Any concerns should be directed to their health care providers. The FDA advised doctors to consider if patients on bisphosphonates for more than five years still need the drugs.