Intravenous Bisphosphonates Linked to ONJ in Cancer Patients, FDA Warns Dentists
May 19, 2005 — The U.S. Food and Drug Administration (FDA) and Novartis Pharmaceuticals Corp. have notified dental healthcare professionals by letter of recommendations that cancer patients considering intravenous (IV) therapy with the bisphosphonates pamidronate disodium (Aredia) or zoledronic acid (Zometa) have a dental examination prior to initiation of therapy and avoid invasive dental procedures while receiving IV bisphosphonate treatment.
The recommendation comes in light of potential risk of osteonecrosis of the jaw (ONJ) associated with use of IV bisphosphonates, according to an alert sent yesterday from MedWatch, the FDA's safety information and adverse event reporting system.
The FDA has received reports of ONJ in cancer patients receiving treatment with IV bisphosphonates, including pamidronate disodium and zoledronic acid. In a majority of reported cases, patients were concurrently receiving chemotherapy and corticosteroids, and development of ONJ was linked to dental procedures such as tooth extraction. Signs of local infection, including osteomyelitis, were also common.
Signs and symptoms of ONJ include (but are not limited to), gum pain, swelling, or infection; poor healing of gums; loosening of teeth; numbness or a feeling of heaviness in the jaw; drainage; and exposed bone. ONJ is variable in severity, ranging from asymptomatic disease in some patients to requirements for partial jaw removal in others. The FDA has advised patients with concomitant risk factors for ONJ (eg, cancer, chemotherapy, corticosteroids, and poor oral hygiene) to consider obtaining a dental examination with appropriate preventive dentistry prior to bisphosphonate therapy initiation.
Because dental surgery may increase the risk of ONJ, invasive dental procedures should be avoided by patients receiving therapy. Dental surgery may also exacerbate ONJ in patients who have developed the condition during the course of treatment.
The FDA notes that there are no data available to suggest whether discontinuation of IV bisphosphonate therapy reduces the risk of ONJ in patients who require dental procedures. Clinical judgment of the treating physician should guide the treatement plan of each patient based on individual benefit/risk assessment.
Pamidronate sodium is indicated for the treatment of hypercalcemia of malignancy, Paget's disease, osteolytic bone metastases of breast cancer, and osteolytic lesions of multiple myeloma.
Zoledronic acid is indicated for the treatment of hypercalcemia of malignancy and for use in conjunction with standard antineoplastic therapy to treat multiple myeloma and bone metastases from solid tumors. Use in patients with prostate cancer should follow evidence of disease progression on at least one hormonal therapy.
Further information concerning dental treatment for cancer patients receiving bisphosphonate therapy, including a patient brochure, may be obtained by contacting Novartis by telephone at 1-800-521-9445.
Healthcare professionals are strongly encouraged to submit a report of any serious adverse events that occur with the use of pamidronate disodium or zoledronic acid to Novartis Pharmaceuticals Corp. by telephone at 1-800-882-6577 or by fax to 1-888-299-4565.
Alternatively, this information may be reported to the FDA's MedWatch Adverse Event Reporting program by telephone at 1-800-FDA-1088, by fax to 1-800-FDA-0178, online at
http://www.fda.gov/MedWatch/report.htm, or by returning the postage-paid FDA form 3500 (available for download at
http://www.fda.gov/MedWatch/getforms.htm) by mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787.
Reviewed by Jacqueline A. Hart, MD
PS- Hey everyone...just called Novatis- the woman who answered tells me that should you have any questions or troubles having dental work done... "have your healthcare professional call this number and ask for Dr Linda Weiss - the product specialist:.....800.521.9445"
They can press 0 (Zero) and reach a person immediately into the menu and be transferred to Dr Weiss.
You can have whomever feels they want to speak with some call..either your dentist, onco or BOTH... they may want to conference call... all phone system can do this have then make ONE call and get every question answered....
According to the rep- Dr Wiess can answer questions on Aredia or Zometta and also this number can give you another referral number for your Dr should you have been on a generic bisphosphonates pamidronate disodium (Aredia)
They will also give them another number to call with their questions~!
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Jeannie P.
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