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THE SIMPLE FACTSTM... Fosamax® (alendronate sodium), is a bisphosphonate drug medication manufactured by Merck and is used to treat osteoporosis.
FDA Review - Bisphosphonates -
On August 25, 2004, the FDA released the results of its ODS Postmarketing Safety Review of various bisphosphonates, incuding Aredia (pamidronate) and Zometa (zoledronic acid), Fosamax (alendronate), Actonel (risedronate). In this report, the FDA recommended that language be added to the labels of some bisphosphonate drugs in order to advise of the risk of osteonecrosis.
Bisphosphonates - e.g., Fosamax -
Health Concerns
Some bisphosponates drugs like Fosamax may have certain side effects or problems that may cause a painful and disfiguring condition - Osteonecrosis - that causes the jaw bone to decay and die (problems with teeth) or possible femur fracture. Merck, the manufacturer of Fosamax, may have failed to warn users of a possible side effect or problem from using the drug Fosamax- Osteonecrosis (also know as ONJ, Jaw Necrosis, Bis-Phossy Jaw, Phossy Jaw, Fossy Jaw or Dead Jaw) and/or femur fracture problems.
Bisphosphonates - e.g., Fosamax -
Medical Studies/Information
JAW Problems
Recently, January 9, 2009, the USC School of Dentistry stated that "Even short-term use of common oral osteoporosis drugs may leave the jaw vulnerable to devastating necrosis," according to a new USC School of Dentistry study appearing in the January 1,2009 Journal of the American Dental Association (JADA).
The JADA study stated that "The findings from this study indicated that even short-term oral use of alendronate led to ONJ in a subset of patients after certain dental procedures were performed. These findings have important therapeutic and preventive implications. (Osteonecrosis; jaw; oral bisphosphonates; alendronate; extraction)"
In addition, The Alliance for Better Bone Health released a statement in connection with Actonel - bisphosphonate - and osteonecrosis of the jaw. The Alliance is made up of Proctor & Gamble (maker of actonel) and Sanofi-Aventis U.S.
In addition, The American Dental Association released a report - "Reports Address Osteonecrosis of the Jaw in Patients Receiving Bisphosphonate Therapy" - in connection with bisphosphonate drugs - e.g., fosamax, actonel, aredia and zometa - and osteonecrosis of the jaw.
In addition, The Journal of Bone and Mineral Research released a report - "Bisphosphonate-Associated Osteonecrosis of the Jaw: Report of a Task Force of the American Society for Bone and Mineral Research" - in connection with bisphosphonate drugs and osteonecrosis of the jaw.
In addition, The American Association of Oral and Maxillofacial Surgeons released a a position paper report - "American Association of Oral and Maxillofacial Surgeons Position Paper on Bisphosphonate-Related Osteonecrosis of the Jaws" - in connection with bisphosphonate drugs - e.g., fosamax, actonel, aredia and zometa - and osteonecrosis of the jaw.
In addition, The Journal of Oncology released a research/position/guideline paper report - "Practical Guidelines for the Prevention, Diagnosis, and Treatment of Osteonecrosis of the Jaw in Patients With Cancer" - in connection with bisphosphonate drugs and cancer patients (breast, multiple myeloma, Paget's disease, prostate) and osteonecrosis of the jaw.
In addition, The American Dental Association released a a clinical presentation position paper report - "Osteonecrosis of the Jaw" - in connection with the use of bisphosphonate drugs - e.g., fosamax, actonel, aredia and zometa - and osteonecrosis of the jaw.
In addition, The American Academy of Periodontology released a statement paper report - "AAP Statement on Bisphosphonates" - in connection with bisphosphonate drugs - e.g., aredia and zometa - and osteonecrosis of the jaw.
Femur Problems
In addition, a recent study has linked the drug Fosamax to a rare femur fracture. The study states that some patients on Fosamax experienced low energy fracture (fractures that may occur when someone falls from standing height). The fractures in the patients appeared in strong looking bones that didn't appear to have signs of osteoporosis. Fosamax's manufacturer, Merck didn't agree with the study.
Other Bisphosphonates Information -
Aredia and Zometa
Aredia and Zometa are bisphosphonate medications or drugs used to treat bone loss - osteoporosis. According to the FDA, Aredia (Pamidronate (Aredia)[treatment of osteolytic metastases of breast cancer and osteolytic lesions of multiple myeloma, as well as hypercalcemia of malignancy (HCM) and Paget’s Disease] and Zometa (zoledronic acid (Zometa)[treatment of patients with multiple myeloma and patients with documented metastases from solid tumors, in conjunction with standard antineoplastic therapy] are potent intravenous bisphosphonates) are manufactured by Novartis. There have been reports to the FDA of osteonecrosis after use of bisphosphonates.
In addition, the FDA reports that Aredia received approval for HCM in 1991, for multiple myeloma in 1995, and for osteolytic bone metastases from breast cancer in 1998. Zometa was approved for HCM in August 2001 and for a broad bone metastasis indication in February 2002. The Zometa package insert was updated in September 2003 and February 2004 to include information on osteonecrosis of the jaw in the adverse events section. The Aredia package insert was subsequently updated, as well. In August 2004, additional changes were made to the Precautions section of the Zometa label, followed by parallel changes to the Aredia label, regarding ONJ. Novartis issued a Dear Doctor letter in September 2004 regarding ONJ.
If you are suffering a side effect/injury such as ostenecrosis (teeth and jaw/femur fracture) from a bisphosphonate (e.g., fosamax), please seek and consult with your healthcare provider as soon as possible.
Have you used the Bisphosphonate drug - Fosamax® - to help treat bone loss/osteoporosis and experienced side effects or problems (teeth, jaw, femur)? Are you suffering from osteonecrosis (teeth and jaw) or a femur fracture (problems and side effects possibly associated with long term use of the alendronate based drug - Fosamax. (bisphosphonates used to treat osteoporosis)?
Quite frankly, the simple factsTM about the Merck drug Fosamax and the possible injuries and/or long term side effects from bisphosphonates - Osteonecrosis (also know as ONJ, Jaw Necrosis, Bis-Phossy Jaw, Phossy Jaw, Fossy Jaw or Dead Jaw) and/or femur fracture or other health complications - that may be caused by taking Fosamax (bisphosphonate) are unacceptable.
If you have used the bisphosphonate drug - Fosamax®, and are suffering side effects or problems - Osteonecrosis or femur fracture, you may have a case/lawsuit and be entitled to compensation.
We are investigating claims of Osteonecrosis (ONJ, Bis-Phossy Jaw, Phossy Jaw, Fossy Jaw, Dead Jaw, Jaw Necrosis, teeth) and femur fracture in connection with possible side effects and problems (short term or long term use) from the use of the bisphosphonate - Fosamax.
In addition, an MDL has been setup in the Southern District of New York for Fosamax litigation (IN RE: Fosamax Products Liability Litigation No. 1789), and an MDL has been setup for Aredia and Zometa litigation in the Middle District of Tennessee (IN RE: Aredia and Zometa Products Liability Litigation No. 1760).
We are here to help you protect your legal rights and the legal rights of your loved ones.
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