Cancer patients who receive bisphosphonates as part of their therapy may develop osteonecrosis of the jaw if they undergo major dental work, according to the pharmaceutical company Novartis Oncology (East Hanover, N.J.) in a letter sent to health care professionals on Sept. 24.
According to the December issue of the FDA Patient Safety News, Novartis notified health care professionals about new precautions for the company’s two bisphosphonate drugs, Zometa (zoledronic acid) and Aredia (pamidronate disodium). These drugs are used to treat hypercalcemia of malignancy and other disease states.
The drugs’ labeling now cautions about reports of osteonecrosis of the jaw—a severe form of bone damage—occurring in cancer patients who received bisphosphonates as a component of their therapy. Many of these patients also were receiving chemotherapy some with corticosteroids, which also are risk factors for osteonecrosis. The majority of the osteonecrosis cases were associated with dental procedures such as tooth extractions, and many of these patients had signs of local infection, including osteomyelitis.
The drugs’ labels now advise people who prescribe these drugs to consider having patients with these and other risk factors undergo dental evaluation and necessary preventive and noninvasive dental care before they start receiving treatment with Zometa or Aredia.
While receiving these drugs, high-risk patients should avoid invasive dental procedures if possible. If patients do develop osteonecrosis of the jaw while receiving bisphosphonate therapy, they should avoid dental surgery.
According to the FDA, "If patients on bisphosphonates do require dental procedures, there are no data available on whether stopping the drugs reduces the risk of osteonecrosis of the jaw. The clinical judgment of the physician should guide each patient’s management, based on an assessment of benefits and risks."
