Novartis AG has received 875 reports of jaw problems in patients treated with two cancer
drugs, Zometa and
Aredia, but it is not clear if the medicines
are responsible, company officials told a U.S. advisory panel on Friday. The drugs are used to treat multiple myeloma
as well as cancer that has spread to the bone from solid tumors.
According to*Reuters, Novartis added a warning to the labels of both drugs last year to alert doctors
to the reports of osteonecrosis of the jaw, or ONJ.
More than 1 million patients have been treated with Zometa since its launch in 2001, Novartis said. Zometa sales topped
$1 billion last year. Aredia is available generically, and Novartis no longer promotes the brand name version.
The
FDA panel did not make any formal recommendations for regulatory action, but some members said Novartis should
do more to alert dentists, patients and others to the issue. The company said it sent letters about the cases to
physicians last year and contacted patient groups and printed brochures.
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