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Caution On Osteonecrosis With Bisphosphonates

Date:
December 16, 2004
Source:
U.S. Food And Drug Administration
Summary:
Novartis has notified healthcare professionals about new precautions for the company's two bisphosphonate drugs, Zometa (zoledronic acid) and Aredia (pamidronate disodium). These drugs are used to treat hypercalcemia of malignancy and other disease states.

Novartis has notified healthcare professionals about new precautions for the company's two bisphosphonate drugs, Zometa (zoledronic acid) and Aredia (pamidronate disodium). These drugs are used to treat hypercalcemia of malignancy and other disease states.

The labeling now cautions about reports of osteonecrosis of the jaw occurring in cancer patients who received bisphosphonates as a component of their therapy. Many of these patients were also receiving chemotherapy, some with corticosteroids, and these are also risk factors for osteonecrosis. The majority of the osteonecrosis cases were associated with dental procedures such as tooth extractions, and many of these patients had signs of local infection, including osteomyelitis.

So the labeling now advises prescribers to consider having patients with these and other risk factors undergo dental evaluation and necessary preventive dental care before starting on Zometa or Aredia treatment.

While on these drugs, high risk patients should avoid invasive dental procedures if possible. If patients do develop osteonecrosis of the jaw while on bisphosphonate therapy, they should avoid dental surgery.

And finally, if patients on bisphosphonates do require dental procedures, there are no data available on whether stopping the drugs reduces the risk of osteonecrosis of the jaw. The clinical judgment of the physician should guide each patient's management, based on an assessment of benefits and risks.

Additional Information:

FDA MedWatch Safety Alert 2004 - Zometa (zoledronic acid)http://www.fda.gov/medwatch/SAFETY/2004/safety04.htm#zometa


Story Source:

The above story is based on materials provided by U.S. Food And Drug Administration. Note: Materials may be edited for content and length.


Cite This Page:

U.S. Food And Drug Administration. "Caution On Osteonecrosis With Bisphosphonates." ScienceDaily. ScienceDaily, 16 December 2004. <www.sciencedaily.com/releases/2004/12/041203100220.htm>.
U.S. Food And Drug Administration. (2004, December 16). Caution On Osteonecrosis With Bisphosphonates. ScienceDaily. Retrieved July 31, 2014 from www.sciencedaily.com/releases/2004/12/041203100220.htm
U.S. Food And Drug Administration. "Caution On Osteonecrosis With Bisphosphonates." ScienceDaily. www.sciencedaily.com/releases/2004/12/041203100220.htm (accessed July 31, 2014).

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