ONJ and Dental Work

A dental examination with appropriate preventive dentistry should be considered prior to treatment with bisphosphonates in patients with concomitant risk factors (e.g. cancer, chemotherapy, corticosteroids, poor oral hygiene). ONJ is a complex problem with multiple risk factors. Typical signs and symptoms of ONJ include, but are not limited to: 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 and exposed bone. The seriousness of ONJ ranges from a patient being asymptomatic to requiring that sections of the jaw be removed. Dentists, oral surgeons, periodontists, prosthodontists, dental hygienists, and other dental health professionals can play a vital role in identifying Osteonecrosis of the jaw and other oral complications of cancer and cancer therapy.


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Novartis and the FDA notified dental healthcare professionals of revisions to the prescribing information about the occurrence of Osteonecrosis of the Jaw (ONJ) observed in cancer patients receiving treatment with intravenous bisphosphonates, including Zometa (generic: zoledronic acid). The FDA posted a letter from Swiss-based Novartis that was sent to dentists warning of the problem. The letter also said patients should avoid invasive dental procedures while on the drug.

Officials from the FDA said they were concerned that many dentists and patients were not aware of the potential for jaw problems. The issue was discussed at an FDA advisory panel meeting in March 2005. Novartis said it had started studies to see if a link between the jaw problems and Zometa exists. At the time, Novartis officials said they had received 875 reports of osteonecrosis of the jaw from December 2002 through February 2005. Zometa was first put on the U.S. market in 2001 and had more than $1 billion in global sales. Zometa is used in the treatment of hypocalcaemia of malignancy, the treatment of patients with multiple myeloma and patients with documented bone metastases from solid tumors, in conjunction with standard antineoplastic therapy.

Dead Jaw



In 2005, the drug maker Merck informed doctors and dental healthcare professionals of the potential dangers of routine dental work for people undergoing Fosamax, Aredia, Zometa or Actonel treatment. Several studies have linked Fosamax, Aredia, Zometa or Actonel with problems involved in tooth extraction and Osteonecrosis of the Jaw (ONJ/Dead Jaw Onset). Generally, when a tooth is pulled, the bones of the jaw begin to rebuild, filling in the gap and removing any dead tissue. Osteonecrosis of the Jaw can interfere with the natural way the mouth and gums heal after such common procedures because the condition inhibits the way in which bones rebuild themselves. Dentists need to be aware of the potential dire consequences that Fosamax, Aredia, Zometa or Actonel use may have on their patients. Early stages of ONJ include painful and loose teeth, swollen gums, and heavy or numb jaws.If you would like to find out more information about a potential Fosamax lawsuit or Fosamax class action, please contact us today!

The following articles provide a more in-depth look at ONJ and bisphosphonate use:

American Dental Association:
www.ada.org/prof/resources/topics/osteonecrosis.asp