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The Food and Drug Administration (FDA) advised dentists and cancer physicians on
Both zoledronic acid and pamidronate are produced by Novartis Pharmaceuticals Corporation of
Zol...
The Food and Drug Administration (FDA) advised dentists and cancer physicians on
Both zoledronic acid and pamidronate are produced by Novartis Pharmaceuticals Corporation of
Zoledronic acid is approved by the FDA to treat high blood levels of calcium in cancer patients (hypercalcemia of malignancy), the treatment of patients with multiple myeloma, and patients with documented bone metastases from their cancers in conjunction with standard cancer treatment. Pamidronate is approved for the treatment of Paget’s disease, bone metastases of breast cancer, and multiple myeloma.
Cancer patients receiving treatment with zoledronic acid and pamidronate have experienced osteonecrosis of the jaw. The revised package inserts for these drugs now recommend that cancer patients receive a dental examination prior to beginning treatment with either of these drugs. The inserts also advise that patients using zoledronic acid or pamidronate should avoid invasive dental procedures during treatment with these drugs. If a patient does develop osteonecrosis of the jaw while using one of these drugs, dental surgery may make the condition worse.
The typical signs and symptoms of osteonecrosis of the jaw 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. Patients with the least serious form of this condition may remain asymptomatic; in the most serious cases, some may require the removal of sections of the jaw.
Zoledronic acid and pamidronate belong to the family of drugs known as bisphosphonates. Other members of this family include the oral drugs alendronate (FOSAMAX) and risedronate (ACTONEL). These two drugs are approved by the FDA to treat osteoporosis in both men and postmenopausal women and to treat Paget’s disease. They are also approved to treat osteoporosis caused by corticosteroids, but should not be used for this purpose. For women at risk of developing osteoporosis, alendronate and risedronate are also approved to prevent osteoporosis from developing.
There have also been reports of osteonecrosis of the jaw associated with the use of oral bisphosphonates in the medical literature. Staff from the Division of Oral and Maxillofacial Surgery, Long Island Jewish Medical Center published a report on cases of osteonecrosis observed in their oral surgery clinic in the May 2004 Journal of Oral and Maxillofacial Surgery.
The researchers reviewed the medical records of all patients who were seen in their clinic between February 2001 and November 2003 who had both a diagnosis of jaw infection and a history of chronic bisphosphonate treatment. They identified 63 cases. Of these 63 cases, 56 had received an injectable bisphosphonate (such as zoledronic acid or pamidronate) for at least one year. Seven patients had been on chronic oral bisphosphonate therapy with alendronate and risedronate.
The FDA convened its Oncologic Drugs Advisory Committee on
In a memo reviewing all of the cases received by FDA, the agency’s Office of Drug Safety reported that osteonecrosis of the jaw was related to alendronate use in 12 cases and to risedronate in one case. The Office of Drug Safety recommended that the professional product labeling for alendronate and risedronate also be revised to warn of the possibility of osteonecrosis of the jaw. At this time, the FDA has not taken such action.
What You Can Do
You should inform your dentist, in addition to your physician and pharmacist, about all drugs that you are taking.
