FREE Case Review (866) 588-0600

FDA to Review Conflicting Data on Bisphosphonates and Esophageal Cancer

In response to new contradictory information regarding oral bisphosphonates and the risk of esophageal cancer, the U.S. Food & Drug Administration (FDA) is once again analyzing safety data related to the popular osteoporosis medications. The two largest studies conducted to date on the issue arrived at two very different conclusions: one found no increase in esophageal cancer while the other found a doubling of the disease in patients who had taken bisphosphonates. Last year, the FDA issued a press release warning of the risk of atypical femur fractures in women taking bisphosphonates.

Fosamax Update 6/1/12: A new study has found that the long-term use of Fosamax may lead to esophageal cancer. The risk of the disease appears to be greater with Fosamax than with any other bisphosphonate osteoporosis medication.

Free Bisphosphonate Esophageal Cancer Case Evaluation: If you or a loved one has developed esophageal cancer or other serious side effect after taking a bisphosphonate drug, 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?

August 1, 2011 – The conflicting information regarding bisphosphonates and esophageal cancer derived from two epidemiological studies that used the same patient database – the United Kingdom’s General Practice Research Database. Despite drawing information from the same source, one of these studies found no increase in the risk of esophageal cancer while the other found a doubling of the esophageal cancer risk among individuals who had 10 or more prescriptions for the drugs over a period of three or more years.

Last month, the FDA issued a press release announcing that its safety review of the issue is ongoing, but stated that the benefits of bisphosphonates may still outweigh the risks. The bisphosphonate class of drugs includes:

According to the FDA, two additional studies utilizing different patient databases found either no increase in esophageal cancer risk or a reduced risk. The administration stated that differences in study design and methodology may account for the discrepancies. Due to the fact that the research was observational rather than randomized, they may be subject to bias and confounding.

When esophagitis and other esophageal events have been identified in bisphosphonate users, it is typically in patients who do not follow specific directions for use of the drugs. Bisphosphonates should be taken with a glass of water just after awakening in the morning. Patients should not lie down or eat or drink anything for at least an hour after taking any oral bisphosphonate.

Bisphosphonate Bone Fractures

In October 2010, the FDA alerted physicians about the risk of atypical femur fractures in female patients taking bisphosphonate medications. In its press release, the FDA stated that it was requiring all manufacturers of these medications to change their labeling to include a safety update warning the public about the risk of atypical femur fractures. 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.”

Side Effects of Bisphosphonates

In addition to the risk of esophageal cancer and atypical femur fractures, bisphosphonates have also been linked to the following serious side effects:

  • Osteonecrosis of the Jaw (Dead Jaw)
  • 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

Nationwide, 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. At least one case 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 osteonecrosis of the jaw. The bisphosphonate 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 drugs. Our attorneys work on a contingency fee basis, which means that you pay no fees or charges unless we achieve a favorable outcome in your case.

Click here to read more about bisphosphonates from Schmidt & Clark, LLP.

Do you have a Bisphosphonate Esophageal Cancer 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 esophageal cancer lawsuits. We are handling individual litigation nationwide and currently accepting new bisphosphonate esophageal cancer cases in all 50 states.

Free Confidential Case Evaluation

Verified 100% Secure SiteTo contact us for a free review of your potential case, please fill out the form below or call us toll free 24 hrs/day by dialing: (866) 588-0600.
Awards & recognition