Caution on Osteonecrosis with Bisphosphonates
FDA Patient Safety News: Show #34, December 2004

Novartis has notified healthcare 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 labeling now cautions about reports of osteonecrosis of the jaw occurring in cancer patients who received bisphosphonates as a component of their therapy. Many of these patients were also receiving chemotherapy, some with corticosteroids, and these are also 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.

So the labeling now advises prescribers to consider having patients with these and other risk factors undergo dental evaluation and necessary preventive dental care before starting on Zometa or Aredia treatment.

While on these drugs, high risk patients should avoid invasive dental procedures if possible. If patients do develop osteonecrosis of the jaw while on bisphosphonate therapy, they should avoid dental surgery.

And finally, 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.

Additional Information:

FDA MedWatch Safety Alert 2004 - Zometa (zoledronic acid).
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm152865.htm


FDA Patient Safety News is available at www.fda.gov/psn