Fosamax Thigh Fracture Problems: FDA Warning

Harvey Kirk

By Harvey Kirk
Posted October 18, 2010


For more than two years, the product liability lawyers at Saiontz & Kirk, P.A. have been investigating potential lawsuits for fractures from Fosamax. Last week, the FDA finally forced the drug maker to add a warning about the possible risk of a Fosamax thigh bone fracture.

>>MORE INFO: Fosamax Thigh Fracture Lawsuit

Fosamax (alendronate sodium) is a popular medication prescribed to treat osteoporosis and reduce the risk of fractures by preventing bone turn-over. However, side effects of Fosamax have been linked to decay of the jaw bone, known as osteonecrosis of the jaw from Fosamax, and reports of low-energy femur fractures, typically occurring with falls from standing height or less.

On October 13, the FDA announced that a thigh fracture warning will be added to all bisphosphonate medications like Fosamax, though they stopped short of decaring the there was a cause and effect relationship between the drugs and femur fractures.

During their review of the Fosamax fractures of the thigh, the FDA discovered that they all appear to be atypical subtrochanteric and diaphyseal femur fractures. These only accounted for 1% of all thigh fracture reports, but when FDA researchers looked into that group, the found that they are predominantly reported by people who have been taking Fosamax or another bisphophonate. The review also suggests that the fractures of the thigh from Fosamax may be connected to long-term use of bisphosphonates.

Although evidence has suggested that there is a connection between Fosamax and a fracture risk for some time, the drug maker has failed to adequately warn consumers.

>>PRIOR POST (3/9/2010): Report on Fosamax Broken Thigh Bones

According to recommendations posted by the FDA (pdf) for consumers taking Fosamax or other bisphosphonate medications for osteoporosis, users should:

  • Review the new medication guide, which will describe symptoms of atypical femur fractures from Fosamax
  • Notify your healthcare provider if you experience symptoms of a Fosamax fracture
  • Notify your healthcare provider if you develop new hip or thigh pain, which is commonly described as dull or aching pain

The FDA is continuing to review the connection between Fosamax and thigh fractures, and recommends that individuals continue to take their medication unless they are told by their doctor to stop. In addition, the agency is urging individuals to report any Fosamax thigh fracture side effects through the FDA’s MedWatch program.


The Fosamax lawyers at Saiontz & Kirk, P.A. are providing free consultations and claim evaluations for individuals who believe they may have suffered a thigh fracture from Fosamax. Lawsuits are also being reviewed for individuals who have developed osteonecrosis of the jaw, osteonecrosis of the hip, osteonecrosis of the knee or osteonecrosis of the shoulder.

To review a potential claim for yourself, a friend or family member, request a free consultation and claim evaluation.

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