Australia bans Novartis' Prexige

Another one bites the dust: Australia's drug regulators have banned the Novartis drug Prexige because of severe liver-related side effects, including two deaths--possibly a third--and two transplants. Patients were advised to stop taking Prexige, a COX-2 inhibitor, immediately. Novartis said it would comply with the authority's decision but that it felt the benefits of Prexige still outweigh its risks.

The drug isn't yet approved for use in the U.S. and Novartis says it still intends to apply to market Prexige here. However, Prexige is already facing an uphill battle because of the COX-2 taint; Prexige is only the latest in a series of COX-2 inhibitors to fall under post-market scrutiny. And the Australian's ban is another link in a chain of pain for Novartis, which had to withdraw its bowel drug Zelnorm in March.

- read the report from the Sydney Morning Herald
- and here's the AFX report

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