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10/1/2004

Bisphosphonates Linked to Osteonecrosis of Jaw in Cancer Patients

Kate Traynor

An announcement from Novartis Pharmaceuticals Corp. and the Food and Drug Administration's MedWatch program warns that certain patients who take bisphosphonates may be at risk for osteonecrosis of the jaw.

In a letter dated Sept. 24, Novartis informed physicians that it had added information about the condition, which develops mainly in those patients receiving a bisphosphonate agent as part of cancer therapy, to the labeling of zoledronic acid injection (Zometa) and pamidronate disodium injection (Aredia).

According to Novartis, most cases of osteonecrosis occurred during dental procedures such as tooth extraction. The company stated that patients receiving cancer therapy that includes a bisphosphonate should avoid invasive dental procedures if possible.

In the letter, Novartis stated that a "dental examination with appropriate preventive dentistry should be considered prior to treatment with bisphosphonates with concomitant risk factors" for osteonecrosis. These risk factors include cancer, chemotherapy, corticosteroid use, and poor dental hygiene. Novartis stated that it is not known whether discontinuing bisphosphonate therapy before undergoing a dental procedure reduces the risk of osteonecrosis.

Novartis has revised the "Precautions" and "Post-Marketing Experience" sections of the labeling for Zometa and Aredia to reflect the association between bisphosphonate therapy and osteonecrosis.