Healthy Skepticism Library item: 11328

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Publication type: news

Elser C.
Novartis Tells Prexige Patients to Get Liver Tests
Bloomberg News 2007 Aug 24
http://www.bloomberg.com/apps/news?pid=20601202&sid=aGLKlHIdSNPc&refer=healthcare

Full text:

Novartis AG told doctors in Europe to test patients taking its Prexige painkiller for serious liver disease after the medicine was pulled from the Australian market earlier this month.

Patients should have regular liver monitoring and people already suffering liver disease or at risk of the illness shouldn’t take the drug, also called lumiracoxib, the U.K.‘s Medicines and Healthcare Products Regulatory Agency said today in a statement on its Web site.

``The balance of risks and benefits of lumiracoxib in the treatment of osteoarthritis will be further evaluated by European Regulatory Authorities in September,’‘ the London-based agency said. Most of the liver cases come with patients taking higher doses than are licensed in the European Union, it said.

Novartis spokesman John Gilardi wasn’t immediately available to comment.

The Therapeutic Goods Administration, which regulates drugs and medical devices in Australia, on Aug. 11 canceled Prexige’s registration after receiving eight reports of serious drug reactions, including two deaths and two liver transplants, the agency said.

Shares of Novartis fell 15 centimes, or 0.2 percent, to close at 63.45 Swiss francs in Zurich today.

To contact the reporter on this story: Chris Elser in London at celser@bloomberg.net