Healthy Skepticism Library item: 11192

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Prexige advice expanded
Pharmacy Daily (Australia) - registration required 2007 Aug 14
http://www.pharmacydaily.com.au

Full text:

THE Therapeutic Goods Administration yesterday offered further information on the withdrawal of Prexige (lumiracoxib) (PD yesterday), warning that all patients using the drug should cease taking it immediately and be assessed for “any clinical or biochemical evidence of liver damage”.

A statement said that although there is limited data on hepatic side effects of the drug, preregistration clinical trials suggested that abnormal liver functions developed while on the
drug were likely to be normalised once lumiracoxib was ceased.

However in the eight serious reports studied here some patients didn’t improve on cessation of the medicine “due to the severity of the hepatic injury.”

The drug’s manufacturer Novartis has set up a helpline for patients at 1800 671 203.

The firm also said it’s alerting healthcare professionals, patients and patient groups in Australia
about the decision.

But despite also undertaking to inform “relevant health authorities around the world about the withdrawal,” Novartis also said it continued to believe the drug had a “positive risk/ benefit profile in the treatment of patients with osteoarthritis and acute pain”.

News service Reuters quoted a Novartis spokesman saying there were no plans to withdraw the drug in markets other than Australia, adding that the firm would continue with plans to file for US marketing approval for Prexige.

He said that liver failure was a “rare, but known side-effect” of all COX-2 inhibitors as well as of other non-steroidal antiinflammatory drugs.