Pharmaceutical

FDA review shows no link between bone treatment and thigh fractures

The Food and Drug Administration (FDA) says data from an ongoing safety review of oral bisphosphonates, such as Fosamax, prescribed for the treatment of bone loss, do not appear to be related to an increased risk of thigh fractures. However, the agency is telling health care professionals to be aware of a possible risk of atypical subtrochanteric femur fractures in patients using bisphosphonates.

The ongoing safety review was initiated in June 2008, following published case reports of this specific type of thigh fracture in patients with osteoporosis taking bisphosphonates. The agency says it will continue to study this issue along with a team of outside experts, which includes members of the American Society of Bone and Mineral Research Subtrochanteric Femoral Fracture Task Force.

Bisphosphonates include Merck’s Fosamax, Roche Holding AG’s Boniva, Novartis AG’s Reclast, and Procter and Gamble Co’s Actonel.

Bisphosphonates have been available for the treatment of osteoporosis for about 10 years, however this isn’t the first time the medication’s safety has fallen under FDA review. Reuters reported that in 2008, the New England Journal of Medicine suggested the drug may increase users’ risk of a serious atrial fibrillation, or abnormal heartbeat. After reviewing the claims, the FDA said data didn’t show an overall risk of heart problems.

Bbisphosphonates, however, have been linked to another serious condition called osteonecrosis of the jaw (ONJ), a painful decaying of the jawbone. Merck faces lawsuits involving nearly 900 cases by patients who say Fosamax caused their ONJ.