Bisphosphonate label revised to include dental exam recommendation

June 17, 2005

Novartis and the FDA have revised the prescribing information of zoledronic acid (Zometa) to include the occurrence of osteonecrosis of the jaw.

Novartis and the FDA have revised the prescribing information of zoledronic acid (Zometa) to include the occurrence of osteonecrosis of the jaw. The updated information recommends that cancer patients receive a dental examination prior to initiating therapy with IV bisphosphonates and avoid invasive dental procedures while receiving bisphosphonate treatment.

For patients who develop osteonecrosis of the jaw while on bisphosphonate therapy, dental surgery may exacerbate the condition, the FDA said.