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Zometa Label Adds Osteonecrosis Of The Jaw Precaution

This article was originally published in The Pink Sheet Daily

Executive Summary

Novartis sends "Dear Doctor" letter to notify oncologists, oral surgeons and urologists of the labeling change. The revised labeling recommends a dental examination prior to bisphosphonate treatment for at-risk patients.

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Zometa, Aredia "Dear Doctor" Letter Sent To Dentists On Jaw Osteonecrosis Risk

Novartis notifies 150,000 dental health professionals about the risk of osteonecrosis of the jaw in patients receiving intravenous bisphosphonates. FDA's Oncologic Drugs Advisory Committee had urged Novartis to notify dentists after an earlier "Dear Doctor" letter was sent to oncologists, hematologists, oral surgeons and urologists.

Zometa, Aredia "Dear Doctor" Letter Sent To Dentists On Jaw Osteonecrosis Risk

Novartis notifies 150,000 dental health professionals about the risk of osteonecrosis of the jaw in patients receiving intravenous bisphosphonates. FDA's Oncologic Drugs Advisory Committee had urged Novartis to notify dentists after an earlier "Dear Doctor" letter was sent to oncologists, hematologists, oral surgeons and urologists.

Novartis' Zometa Adds Warning On Renal Safety

Revised labeling recommends dosing should be decreased for patients with mild-to-moderate renal impairment, based on the patient's creatinine clearance levels. Novartis recommends identification and management of "factors predisposing of renal deterioration."

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