The United States Food and Drug Administration (FDA) warns of a potential link between Fosamax use and femur fractures following a March 2010 safety communication which announced the agency's ongoing safety review of Fosamax. Since the release of this safety communication, the agency reviewed the America Society for Bone Mineral Research Task Force report, along with other available data. This additional data has found that Fosamax and other bisphosphonate drugs need additional femur fracture warnings added to their warnings and precautions sections and medication guides. These warnings are only some of the medical problems with Fosamax.
The FDA has also recently gone over several studies about the link between Fosamax and femur fractures. This review has lead to the FDA to release a warning about Fosamax and bisphosphonate use. The FDA warning on Fosamax use and femur fractures reads: “ 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. 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.”
Since the warning the FDA has been able to review all available data on bisphosphonate use, including data summarized in the American Society for Bone Mineral Research Task Force report. This 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.
Currently both Merck and the FDA agree that more research is needed to link Fosamax use to atypical femur fractures. Many studies suggest an overall benefit from taking Fosamax for patients who are at risk for osteoporosis. In fact, bisphosphonates can help prevent hip and spine fractures, which for many patients can potentially lead other serious conditions and even death. Before starting bisphosphonate drugs like Fosamax patients should consult with their doctors and become properly aware of any possible side effects the drug may have.
URL References:
- http://abcnews.go.com/WN/WellnessNews/fda-consult-experts-fracture-risk-bone-drugs/story?id=10065341#.T132CYHxqz4
- http://www.fda.gov/Drugs/DrugSafety/ucm229009.htm
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