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FDA Panel to Review Bisphosphonate Bone Fracture Side Effects

On September 9, an FDA advisory committee is set to meet to discuss the growing number of serious side effects reported in connection with Fosamax and other bisphosphonate medications. These osteoporosis drugs have been increasingly linked to severe bone fractures and osteonecrosis of the jaw (ONJ). In addition to Fosamax, other medications in the bisphosphonate class include Actonel, Boniva and Reclast.

Fosamax Femur Fracture Update 3/13/13: A new study has identified a causal link between Fosamax and nonhealing femur fractures. The research, which was published in last month’s edition of the Journal of Bone & Joint Surgery, found that nonhealing femur fractures are not just associated with Fosamax and other diabetes drugs, but directly caused by them. Click here to learn more.

Free Bisphosphonate Drug Case Evaluation: If you or a loved one has suffered a serious injury after taking a bisphosphonate drug for a extended period of time, you should contact our law firm immediately. You may be entitled to compensation by filing a lawsuit and we can help.

What’s the problem?

July 11, 2011 – The panel of independent advisers to the FDA will attempt to determine whether the risk of ONJ and bone fractures are linked to the long-term use of bisphosphonates, and whether there should be a recommended duration for their use. While the panel’s recommendations are not required to be followed by the FDA, the administration typically agrees with the guidance of independent experts.

Bisphosphonate drugs are designed to strengthen the bones of post-menopausal women suffering from osteoporosis. However, long-term use of these medications has been linked to ONJ, a painful and debilitating condition that causes the jaw bone to decay and rot. More recently, bisphosphonates have been associated with a growing number of reports involving spontaneous femur fractures, the majority of which occurred with little or no trauma. Drugs in the bisphosphonate class include:

FDA Warning on Bisphosphonates

In response to the increasing number of side effects reported in bisphosphonate users, the FDA in October 2010 required all manufacturers of these medications to change their labeling to include a safety update warning the public about the risk of atypical femur fractures. The new labels were also required to include information instructing consumers to seek immediate medical attention if they experience new groin or thigh pain while taking the drugs. According to the FDA press release:

“Atypical subtrochanteric femur fractures are fractures in the bone just below the hip joint. Diaphyseal femur fractures occur in the long part of the thigh bone. These fractures are very uncommon and appear to account for less than 1% of all hip and femur fractures overall. Although it is not clear if bisphosphonates are the cause, these unusual femur fractures have been predominantly reported in patients taking bisphosphonates.”

JAMA Study on Bisphosphonate Femur Fractures

In February 2011, a study published in the Journal of the American Medical Association (JAMA) reported that the long-term use of bisphosphonates increases the risk for subtrochanteric and femoral shaft fractures in older women. According to the study’s authors, “These findings also highlight the need for a thoughtful assessment of individual risk of fracture when considering extended bisphosphonate therapy and that long-term use of these drugs may warrant reconsideration, especially in patients at relatively low risk of fracture.”

A growing number of lawsuits have been filed against bisphosphonate manufacturers, claiming that the companies failed to warn the public about the risk of severe side effects. To date, at least one claim has resulted in a jury awarding a plaintiff $8 million after finding that Merck failed to adequately research Fosamax and warn about the risk of ONJ. The bisphosphonate side effects lawyers at Schmidt & Clark, LLP believe that drugmakers should be held accountable for their failure to properly warn consumers of the risk of these dangerous side effects. Our attorneys operate on a contingency fee basis, which means you pay no fees or charges unless we achieve a favorable outcome in your case. Bisphosphonate side effects currently being pursued by our firm for potential lawsuits include:

  • Osteonecrosis of the Jaw (Dead Jaw)
  • Atypical femur fractures
  • Osteomyelitis
  • Pain
  • Swelling or infection of the gums
  • Loosening of the teeth
  • Poor healing of the gums
  • Numbness or a feeling of heaviness in the jaw
  • Drainage
  • Exposed bone
  • Hip Fractures
  • Renal failure

Do I have a Bisphosphonate Lawsuit?

The Product Liability & Defective Drug Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in bisphosphonate drug lawsuits. We are handling individual litigation nationwide and currently accepting new bisphosphonate cases in all 50 states.

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