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FDA Looks Into Bisphosphonates and Femur Fractures

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By Minara El-Rahman on March 12, 2010 10:05 AM

After a flurry of reporting that bisphosphonates and bone fractures such as femur fractures could be linked, the Food and Drug Administration (FDA) has announced that it will be conducting an ongoing safety review of oral bisphosphonates and femur fractures. The FDA has made it clear that it this point, it has not found a clear connection between bisphosphonate use and a risk of unusual femur fractures. The FDA intends to use the expertise of outside experts such as members of the American Society of Bone and Mineral Research Subtrochanteric Femoral Fracture Task Force.

Recently, ABC News reported that there are studies that indicate that there may be a link between prolonged use of bisphosphonates and the increased risk of bone fractures such as femur fractures. This is troublesome to some doctors. Dr. Kenneth Egol, professor of orthopedic surgery at NYU Langone Medical Center told ABC News about how these patients are experiencing bone fractures: "We are seeing people just walking, walking down the steps, patients who are doing low-energy exercise. Very unusual, the femur is one of the strongest bones in the body."

ABC News reports that patients who take these drugs for more than five years can suffer from spontaneous bone fractures. There has also been an alleged link between the drugs and severe musculoskeletal pain, as well as to a severe bone-related jaw disease called osteonecrosis. Merck denies this link. ABC News quotes a statement released by Merck as saying, "In worldwide post-marketing experience with FOSAMAX/FOSAMAX Plus D, rare reports consistent with osteonecrosis of the jaw have been received. Many of these reports lack sufficient clinical details to make definitive assessments and/or are confounded, particularly since a generally accepted definition of ONJ in the general population is unknown." A lawsuit was filed back in 2006 claiming that Fosamax use caused ONJ in a patient named Linda Secrest.

In 2008, bisphosphonate sales surpassed $3.5 billion according to data supplied by from IMS Health. There were over 37 million prescriptions were written for the osteoporosis medication Fosamax in 2008.

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