Fosamax and Boniva belong to a class of drugs known as bisphosphonates and are prescribed for the prevention and treatment of osteoporosis. These types of drugs are prescribed to slow the process of bone loss, increase bone density, and reduce the risk of bone fracture. A widely-used option for the prevention and treatment of osteoporosis, approximately four million women take bisphosphonates in the United States alone. However, research has indicated a link between long-term use of bisphosphonates and the development of atypical femoral fractures, osteonecrosis of the jaw (ONJ) and esophageal cancer.
Common adverse side effects include:
1. Femur fractures
On October 13, 2010, the U.S. Food and Drug Administration (FDA) issued an announcement indicating that there may be an increased risk of atypical femoral fracture in patients taking bisphosphonates for an extended period of time. The FDA issued the warning regarding bisphosphonates prescribed for the treatment of osteoporosis, including drugs such as Fosamax, Actonel, Atelvia, Reclast and Boniva. The FDA advised the manufacturers of these bisphosphonate drugs to change their labels and medication guides to reflect the warning regarding atypical femoral fractures associated with long-term use of bisphosphonates.
Numerous studies have cited the troubling evidence of increased risk of femur fracture resulting from prolonged use of bisphosphonate drugs:
- Atypical femur fractures in patients taking bisphosphonates can occur even as a result of minor trauma, and can occur even when no trauma has taken place.
- Although bisphosphonate drugs are prescribed to inhibit further bone loss, prolonged use of this type of drug may actually lead to an increase in the risk of femur fractures.
- Prolonged use of bisphosphonate drugs is defined as continuous use of the drug for longer than five years.
- Among older female patients, prolonged use of bisphosphonates is associated with a higher risk of developing femoral fractures.
- Recent studies have shown that femoral fractures could be prevented if a patient did not take bisphosphonates for more than five years.
2. Osteonecrosis of the jaw
Peer-reviewed medical journals have also raised concerns regarding the development of osteonecrosis of the jaw in patients taking bisphosphonates:
- Osteonecrosis of the jaw (ONJ), also known as jawbone death, takes place when a patient’s jaw bone does not heal after suffering minor trauma.
- Symptoms of osteonecrosis of the jaw include infection, swelling, exposure of bone in the jaw, and pain.
- This condition can be very difficult to treat. ONJ can be resistant to therapy and can cause morbidity in the patient.
- The risk of developing ONJ associated with bisphosphonate use appears to be related to longer exposure to these types of drugs.
- ONJ as related to bisphosphonates was seldom seen before 2003, when the condition was first reported. This was five to ten years after these drugs were approved for use in osteoporosis treatment in the United States.
- Results from a report published in 2009 in the Journal of the American Dental Association found that 4% of women in the study who took Fosamax (a specific type of bisphosphonate) for osteoporosis treatment developed osteonecrosis of the jaw (ONJ) after undergoing dental procedures where teeth were pulled.
3. Esophageal cancer
On July 21, 2011, the FDA issued an announcement indicating the agency’s continued safety review of the relationship between oral bisphosphonate use and the development of esophageal cancer in patients taking these types of drugs. The FDA stated that there were conflicting studies regarding this risk. One study, however, found that the risk of esophageal cancer doubled in those patients with ten or more prescriptions of bisphosphonate drugs, or in those patients who took bisphosphonate drugs for more than three years.
The FDA recognized that use of oral bisphosphonates may cause irritation of the patient’s esophagus. This irritation in turn can lead to inflammation or sores in the esophagus. These sores can cause bleeding in the patient’s esophagus.
If you or a loved one have taken a bisphosphonate drug such as Fosamax or Boniva, please contact our firm at 1-800-247-1623 or firstname.lastname@example.org for a free consultation to discuss your legal rights.
Actonel® is a registered trademark of Procter & Gamble Pharmaceuticals, Inc. and is used for informational and product identification purposes only. Atelvia® is a registered trademark of Warner Chilcott Company and is used for informational and product identification purposes only. Boniva® is a registered trademark of Roche Therapeutics Inc. and is used for informational and product identification purposes only. Didronel® is a registered trademark of Procter & Gamble Pharmaceuticals, Inc. and is used for informational and product identification purposes only. Fosamax® is a registered trademark of Merck & Co., Inc. and is used for informational and product identification purposes only. Skelid® is a registered trademark of Sanofi-Aventis and is used for informational and product identification purposes only. Aclasta® is a registered trademark of Novartis AG and is used for informational and product identification purposes only. Reclast® is a registered trademark of Novartis AG and is used for informational and product identification purposes only.