Alert on cancer patients issued
Research links bisphosphonate drugs, osteonecrosis of the jaw
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Posted Nov. 18, 2005 |
By Jennifer Garvin The ADA Division of Science continues to receive questions from members about the link between bisphosphonate drugs and osteonecrosis of the jaw in cancer patients.
Last May, Novartis Pharmaceuticals Corp. sent a letter to dentists informing them that cancer patients being treated with Aredia or Zometa were at risk for developing ONJ.
The company recommends that cancer patients using these drugs avoid invasive dental procedures because dental surgery may exacerbate ONJ in some patients. In the letter Novartis said, “clinical judgment by the treating physician should guide the management plan of each patient based on individual benefit/risk assessment.”
Intravenous bisphosphonates (Aredia and Zometa) are drugs that are used to treat cancer patients to help prevent or control bone destruction due to metastatic bone disease. Dentists should ask patients about any ongoing or recent medical treatments. Patients may not remember to tell their dentist that they are receiving these drugs, because they are administered in the oncology chemotherapy unit.
According to a Novartis white paper developed by a team of eight medical professionals, including five dentists, the recommended treatment for patients receiving intravenous bisphosphonate therapy is to:
- Maintain excellent oral hygiene to reduce the risk of dental and periodontal infections.
- Check and adjust removable dentures and perform routine dental cleanings (being sure to avoid soft-tissue injury, especially in tissue overlying bone.)
- Aggressively manage dental infections non-surgically. Endodontic therapy is preferable to extractions when possible. It may be necessary to carry out coronal amputation with subsequent root canal therapy on retained roots to avoid the need for extractions and the potential development of osteonecrosis.
- If surgery is required in patients with established osteonecrosis, stopping or temporarily stopping bisphosphonate therapy may be considered.
Additionally, osseointegrated dental implants may result in further osteonecrosis and are contraindicated.
Novartis recommends that cancer patients receive a dental examination prior to initiating therapy with Aredia or Zometa, and avoid invasive dental procedures while receiving these drugs. The company has added precautionary information on ONJ to the package insert for both products.
Novartis urges any dentist who observes serious adverse events related to Aredia or Zometa to call 1-800-882-6577, or to call the Food and Drug Administration’s MedWatch Adverse Event Reporting program at 1-800-FDA-1088. The FDA’s Web site is another online resource.
For more information, contact Novartis Oncology Medical Services at 1-888-669-6682.
Also, for more information, go to ADA.org or contact the Division of Science via the ADA toll-free number at Ext. 2553 or e-mail science@ada.org.
The December issue of the Journal of the American Dental Association contains three articles on bisphosphonate-associated osteonecrosis, including a position paper from the American Academy of Oral Medicine, a review of current knowledge and strategies for prevention and early recognition as well as case reports.
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