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Food And Drug Administration - Oncologic Drugs Advisory Committee Meeting (March 4, 2005)
5.4.05

The committee discussed safety concerns, specifically osteonecrosis of the jaw (ONJ), associated with two bisphosphonates, NDA 21-223, ZOMETA® (zoledronic acid) Injection and AREDIA®, NDA 20-036 (pamidronate disodium for injection), both from Novartis Pharmaceuticals Corp.

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You might also be interested in :
Share via del.icio.us Share via Digg OSTEONECROSIS OF THE JAWS

Osteonecrosis of the jaws is a condition whereby there is loss or destruction of the bone underneath the teeth. This loss of bone appears to be caused by a combination of poor blood supply and impaired bone remodeling or healing.
  AAOMS Position Paper on Bisphosphonate-Related Osteonecrosis of the Jaws
  Bisphosphonate-related osteonecrosis of the jaw (BRON) adversely affects the quality of life and produces significant morbidity in afflicted patients. Oral and maxillofacial surgeons have been responsible for counseling, managing, and treating a majority of these patients. The strategies set forth in this position paper were developed by a Task Force appointed by the American Association of Oral and Maxillofacial Surgeons (AAOMS).
  American Society for Bone and Mineral Research (ASBMR) Issues report on ONJ risk
  The American Society for Bone and Mineral Research (ASBMR) announced today the publication of a report that examines the link between a class of widely prescribed drugs used to strengthen bones and the disorder known as Osteonecrosis of the Jaw (ONJ). The report, authored by an international, multidisciplinary task force, was convened by the ASBMR to look at the possible association between ONJ, a deterioration of the jawbone, and a class of drugs known as bisphosphonates, which in recent years have been linked to the condition.
  Bisphosphonate-associated osteonecrosis of mandibular and maxillary bone.
An article from Cancer, in which researchers from the College of Dental Medicine, Nova Southeastern University in Fort Lauderdale, Florida present results of a study of 17 patients with cancer with bone metastases and 1 patient with osteopenia who received treatment with bisphosphonates and who subsequently developed osteonecrosis of the mandible and/or maxilla.
  Journal of the National Cancer Institute
  Intravenous Bisphosphonate Therapy andInflammatory Conditions or Surgery of the Jaw: A Population-Based Analysis
  Mayo Clinic Consensus Statement for the Use of Bisphosphonates in Multiple Myeloma
  A multidisciplinary panel consisting of hematologists, dental specialists, and nurses specializing in the treatment of myeloma reviewed available data concerning the use of bisphosphonates. Guidelines for the use of bisphosphonates in MM were developed. This link is to the full article.
  NEJM Publishes Correspondence On ONJ
  The New England Journal of Medicine published correspondence from Drs. Durie, Richardson, Duck and Tarassoff on Osteonecrosis of the Jaw in its July 7, 2005 issue (N Engl J Med. 2005 Jul 7;353(1):99-102; discussion 99-102.)
  Novartis and FDA notify dental healthcare professionals of revisions to the prescribing information
The prescribing information recommends that cancer patients receive a dental examination prior to initiating therapy with intravenous bisphosphonates and avoid invasive dental procedures while receiving bisphosphonate treatment.
  OSTEONECROSIS OF THE JAWS IN MYELOMA:
Time Dependent Correlation with AREDIA and ZOMETA Use
  At the 2004 Annual Meeting of the American Society of Hematology, Dr. Durie presented the results of the web-based survey that many of you were kind enough to help us with. We are encouraged by the discussions that have ensued and are hopeful that this will help us raise awareness about this very serious issue and facilitate timely action.
  Osteonecrosis Web Survey Results Presented At 2004 ASH Meeting
  Special Advisory: Osteonecrosis of the Jaw
  Use of Bisphosphonates in Multiple Myeloma: IMWG Response to Mayo Clinic Consensus Statement
Published in the Mayo Clinic Proceedings 2007;82:516-522
  Wall Street Journal Article On Osteonecrosis Of The Jaws
  You can also read a Wall Street Journal article that discusses this issue and includes a quote from Dr. Durie
  Aredia/Zometa and osteonecrosis of the jaws
  Food and Drug Administration (FDA) MedWatch Postings About Osteonecrosis Of The Jaw
  FDA and Novartis notified healthcare professionals of revisions the PRECAUTIONS and ADVERSE REACTIONS sections of labeling for Aredia and Zometa

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