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Home Industry News Novartis arthritis drug recalled

Novartis arthritis drug recalled

13th August 2007

Prexige (lumiracoxib) has been recalled in Australia following reports of links to serious adverse effects in patients administered with the treatment.

According to reports, eight patients suffered severe liver damage after using the drug, with two dying and the same number requiring organ transplants.

The compound was approved for use in Australia in July 2004, though it has not yet been approved in the US, with analysts now reporting that such approval is now unexpected, while the drug is currently being rolled out across Europe.

In Australia, the Therapeutic Goods Administration (TGA) has urged patients taking the drug to see their physicians, with the organisation predicting further reports of adverse effects in the 60,000 Australians who have received the treatment.

“It is not unexpected that we will find more adverse events as people go back to their doctors to be assessed and to seek alternative treatment,” a TGA spokeswoman told the Daily Telegraph in Australia.

Reuters reports that Novartis has agreed to comply with the requests of the TGA, while the firm maintains that the compound has a positive benefit/risk profile for the treatment of patients suffering acute pain and osteoarthritis.

Following its launch in the UK in December 2005, Prexige completed its mutual recognition process in Europe in November 2006, clearing the compound for approval across the EU.

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