Sept 22 – US: Patients sue corporation for risky drug side effect

From: The Daily Targum

The first case in a mass litigation against Novartis Pharmaceutical Corporation for allegedly failing to inform customers of the risks associated with two of the firm’s cancer drugs will begin next Monday in Middlesex County Superior Court….The question before the court will concern the safety of Aredia and Zometa, medications Novartis developed to treat cancers of the bone, according to court documents.

Plaintiffs in the case allege that the drugs in dispute caused cells in the bone of the jaw to die unnecessarily.

The U.S. Food and Drug Administration approved Aredia for sale in 1996 and Zometa in August 2001, according to centerwatch.com, an online pharmaceutical journal.

After doctors and medical researchers warned the company of the risk of osteonecrosis of the jaw associated with Aredia and Zometa, Novartis decided to add a warning label to the drugs’ packaging in 2004, according to the complaint.

Also at issue in the suit is Novartis’ redeployment of Zometa in treating diseases other than cancer.

Click on the links for more information.

Relevant Nexreg Compliance Links: CPSC compliance, OSHA MSDS authoring, MSDS authoring