Bisphosphonate, Thigh Fracture Link Not Validated - By: Katie Kelley

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 in the bone just below the hip joint - 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 is a slow death of bone tissue in the jaw that occurs because of poor blood supply to the bone. 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. In January 2010, a federal judge refused to dismiss a lawsuit stating Fosamax was responsible for severe jaw damage in a woman who took the medication for close to eight years.

Merck has maintained that Fosamax has not been associated with 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.

The FDA recommends that patients continue to take the prescribed medication unless directed otherwise by their doctor. Healthcare professionals should be aware of a "possible risk" of atypical subtrochanteric femur fractures in oral bisphosphonates patients, but the FDA has declined further action until more research has been conducted.

About the Author

Visit http://fosamax.legalview.info/ for a FREE consultation with a Fosamax attorney and to learn more about the potential side effects from the osteoporosis medication. In additional to unsafe drugs litigation, LegalView.info has information about finding a Levaquin lawyer or wrongful termination law.

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