Fda: Osteoporosis Medication Not Responsible For Thigh Fractures


The U.S. Food and Drug Administration issued a statement stating they did not find a link between thigh fractures and oral bisphosphonates – a type of osteoporosis medication, despite lawsuits alleging otherwise.

After several reports surfaced showing an increased number of atypical subtrochanteric femur fractures in women prescribed oral bisphosphonates, the FDA began investigating the osteoporosis medication. The fractures occurred just below the hip joint in the femur – the largest bone in the human body – an unusual place for a break to occur, which prompted the investigation.

Bisphosphonates are a type of osteoporosis drug used to offset bone loss and prevent bone fractures in menopausal women. The following popular medications are oral bisphosphonates:

*Fosamax – Merck and Co Inc.
*Boniva – Roche Holding AG
*Reclast – Novartis AG
*Actonel – Warner Chilcott

The FDA requested information from the oral bisphosphonates manufacturers in June 2008, however, did not find an increased rick for women using the medications. Despite the clear connection between the two, the FDA is currently working with outside sources to further examine the issue.

Bisphosphonates have a controversial history. In 2008, the drugs were investigated after several reports linked them to an increased risk of cardiovascular complications, although the FDA has since issued a statement stating no overall heart risks exist.

Additionally, Fosamax, a popular bisphosphonate, has been linked osteonecrosis, or bone death of the jaw – a potentially life-threatening side effect. Osteonecrosis occurs when poor blood supply to the bone causes slow death of the bone tissue in the jaw. ONJ side effects include loosening of teeth, exposed bone and mouth swelling.

Merck is facing close to 900 Fosamax lawsuits from patients alleging permanent jaw damage. A federal judge refused to dismiss a Fosamax lawsuit in January 2010 that alleged the drug was responsible for sever jaw damage in an Indiana woman who took the medication for nearly eight years.

The manufacturer, Merck, has repeatedly denied any association between Fosamax and increased fracture risks or ONJ. Ron Rogers, Merck’s spokesman stated that “In clinical studies, Fosamax has not been associated with increased fracture risk at any skeletal site.” Until generic versions became available, Fosamax generated close to $3 billion in sales for the company.

Unless directed otherwise by their doctor, the FDA recommends that patients continue to take their prescribed medication. The FDA has advised healthcare professionals to be aware of the “possible risk” of atypical subtrochanteric femur fractures in patients taking oral bisphosphonates, although further action has not been decided at this time.