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U.S. Department of Health and Human Services

Safety

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Zometa (zoledronic acid) Injection

Audience: Oncologists, dentists, and other healthcare professionals

FDA and Novartis notified healthcare professionals of revisions the PRECAUTIONS and ADVERSE REACTIONS sections of labeling, describing spontaneous reports of osteonecrosis of the jaw mainly in cancer patients, who have received bisphosphonates as a component of their therapy. A dental examination with appropriate preventive dentistry should be considered prior to treatment with bisphosphonates in patients with concomitant risk factors (e.g. cancer, chemotherapy, corticosteroids, poor oral hygiene).

[September 24, 2004 - Letter - Novartis]