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.
1. I have read many articles concerning Zometa, Fosamax and Aredia side effects.
Here is a Zometa and Fosamax side effects one from USA today http://www.usatoday.com/news/health/2005-03-13-jawbone-deaths_x.htm
Also it looks like a lawsuit has been filed against Zometa. The attorney's name is John Threadgill,says he is the nation's leading lawyer and that this is a federal case. So he is accepting cases nationwide.
Posted at 6:08PM on Sep 26th 2005 by clayton