Bisphosphonate label now includes precaution about osteonecrosis

October 14, 2004

Revisions have been made to the precautions and adverse reactions sections of the label for the bisphosphonate zoledronic acid (Zometa).

Revisions have been made to the precautions and adverse reactions sections of the label for the bisphosphonate zoledronic acid (Zometa).

Among patients with concomitant risk factors (eg, cancer, chemotherapy, corticosteroids, poor oral hygiene), a dental examination with appropriate preventative dentistry should be considered before treatment with bisphosphonates, according to a letter from the drug's manufacturer, Novartis.

The FDA and Novartis notified health care professionals of spontaneous reports of osteonecrosis of the jaw, mainly of cancer patients, who have received bisphosphonates as a component of their therapy. Zoledronic acid injection is indicated for the treatment of hypercalcemia of malignancy and for the treatment of patients with multiple myeloma and those with documented bone metastases from solid tumors, including prostate cancer, in conjunction with standard antineoplastic therapy.