Fosamax Connected to Rare Thigh Fractures

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Fosamax Connected to Rare Thigh Fractures

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A new study published on line by the Archives of Internal Medicine said it found a link between bisphosphonate use and atypical thigh fractures. Two of the more commonly used osteoporosis drugs are Fosamax and Actonel. The new study examined the records of 477 patients ages 50 years and older who were treated for certain kinds of broken legs between 1999 and 2010. This study was conducted by doctors at the University Hospitals of Geneva in Switzerland.

Of those 477 records examined, 438 had the typical kinds of fractures caused by falls and other traumatic events. But, of the 39 patients who had atypical fractures (where the thigh snaps apart with minimal or no trauma), 32 had taken a bisphosphonate drug. Though these types of femur fractures are rare, even for someone taking a bisphosphonate drug, the new study associates an increased risk for atypical fractures for people taking Fosamax or Actonel for an extended period of time. The longer a person takes one of these drugs, the risk of a fracture increases according to the study. It concluded: “Atypical femoral fractures were associated with bisphosphonate use; longer duration of treatment resulted in augmented risk”.

The FDA warned patients and health providers about the risk of atypical thigh bone fractures in October of 2010. The FDA required the Warnings and Precautions section of the labels be updated of all bisphosphonate drugs approved for the prevention or treatment of osteoporosis. FDA also required a new Limitations of Use statement in the Indications and Usage section of the labels for these drugs.Â The FDA stated that risks are increased in people using Fosamax for five years or more. These fractures, while rare, have been mostly reported in patients taking Fosamax or other drugs of this type. Last year, a panel of experts convened by the FDA expressed concern about atypical fractures, though the panel stopped short of recommending limits on use of the drugs.

The bisphosphonates drugs had $4.2 billion in U.S. sales last year according to IMS Health, a data provider. The FDA listed the bisphosphonates affected by the notice as Fosamax®, Fosamax Plus D®, Actonel®, Actonel with Calcium®, Boniva®, Atelvia®, and Reclast®.

If you took a bisphosphonate and developed a side effect including a bone fracture, call Longo Legal, PLLC toll free at 855-566-4648. We may be able to help.

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