NEWS - FDA adds femur fracture warning to bisphosphonate labels

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FDA Adds Femur Fracture Warning to Bisphosphonate Labels

From Medscape Medical News

Lowes

October 13, 2010 — Bisphosphonates approved for the treatment of

osteoporosis will now bear a label warning about the possible

increased risk for 2 types of atypical femur fractures, the US Food

and Drug Administration (FDA) announced today.

One type of break, subtrochanteric femur fracture, occurs just below

the hip joint. Another type, diaphyseal femur fracture, is in the long

part of the bone. Both are very uncommon, accounting for less than 1%

of all hip and femur fractures overall, according to the agency.

Risedronate sodium, alendronate

The FDA's decision to add a warning about the fractures to the labels

of bisphosphonates comes in the wake of a recommendation to do so by a

task force of the American Society for Bone and Mineral Research. In a

report released last month, the task force said that of 310 cases of

atypical femur fractures under study, 94% of the patients had been

taking bisphosphonates, most for more than 5 years. The task force

stopped short of declaring that the medications cause the fractures.

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Read the full article here:

http://www.medscape.com/viewarticle/730388

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