September 2004: Novartis and FDA Revise Bisphosphonate Prescribing Information
Novartis Pharmaceuticals Corporation and the U.S. Food and Drug Administration (FDA) notified dental healthcare professionals of revisions to prescribing information to describe the occurrence of Osteonecrosis of the Jaw (ONJ) observed in cancer patients receiving treatment with intravenous bisphosphonates. Novartis manufactures and sells Aredia and Zometa, bisphosphonate medicines used to inhibit cancer bone loss and bone metastases (cancerous cells entering the bone), respectively. The prescribing information recommends that cancer patients receive a dental examination prior to starting bisphosphonate treatment, and that they avoid invasive dental procedures while on these medications.
Contact a qualified product liability attorney to make sure your rights are protected.