Reactions 1042 - 12 Mar 2005

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More reports of jaw osteonecrosis with Zometa and Aredia Novartis has informed a US FDA Advisory panel that the company has now received 875 reports of osteonecrosis of the jaw in patients receiving Zometa [zoledronic acid] or Aredia [pamidronic acid].1 Novartis has also advised that there have been > 1 000 000 Zometa prescriptions since the drug was launched onto the US market in 2001, and that the company no longer markets Aredia in the US. Although no formal recommendations for regulatory action were made by the Advisory panel, some of the panel suggested that Novartis should increase efforts to alert patients and health professionals of the issue.2 Dr Carol Pamer, a reviewer in the FDA Office of Drug Safety, commented that although jaw osteonecrosis is rare, the number of reports received by the FDA associated with Zometa and Aredia was steadily increasing. Dr Pamer said that the FDA believes the reported cases "present a highly plausible safety signal" for Zometa and Aredia. 1. Dow Jones. FDA Raises Safety Concerns On Novartis Bone Drugs. Media Release : 4 Mar 2005. Available from: URL: http://money.cnn.com. 2. Reuters. Novartis sees jaw damage in cancer drug patients. Media Release : 4 Mar 2005. Available from: URL: http://www.reuters.com. 800999245

» Editorial comment: In October 2004, Novartis updated the US Zometa and Aredia labels to inform of reports of jaw osteonecrosis, most of which were associated with dental procedures [see Reactions1022: 3, 9 Oct 2004; 800967457], and in December 2004, the Canadian Zometa and Aredia labels were similarly updated [see Reactions 1033: 3, 8 Jan 2005; 800999106].

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Reactions 12 Mar 2005 No. 1042