Suspected Link Between Bisphosphonate and Thigh Fracture Ruled Out by FDA
US Food and Drug Administration

On Wednesday, the US Food and Drug Administration officials confirmed that they have not been able to find any link between bisphosphonate osteoporosis drugs, like Merck & Co Inc.'s Fosamax, and thigh bone fractures.

The official statement was issued by the FDA after the publication of case reports of some atypical subtrochanteric femur fractures, or fractures which happen in the bone which is right below the hip joint, in women suffering from osteoporosis and were on oral bisphosphonates.

Bisphosphonates are a class of medicines which are aimed at preventing bone fractures and overshadowing bone loss which is generally linked with menopause. Popular ones include Fosamax, Roche Holding AG's Boniva, Reclast by Novartis and P&G's Actonel.

In June of 2008, the FDA had specific information from all manufacturers of bisphosphonate with regards to all these types of fractures.

The agency has now specified that a thorough review of the data obtained has revealed that there is no increased risk of fractures in women using these drugs.

"The data that FDA has reviewed have not shown a clear connection", the agency said.

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