Novartis’ Prexige withdrawn in Australia

Executive Summary

The Australian government is withdrawing Novartis' Prexige (lumiracoxib) after two patients died of liver injury following treatment with the COX-2 inhibitor. The Australian Therapeutic Goods Administration says Aug. 10 that since March it had received eight reports of serious hepatic adverse reactions associated with the drug. Novartis said approximately 60,000 people have been treated with Prexige in Australia and that the majority received the 200 mg formula. The company has an NDA for a 100 mg dose pending with the FDA. In 2003, FDA issued a "not approvable" letter for Prexige citing concerns about the drug's potential for liver toxicity (1"The Pink Sheet" Sept. 29, 2003, p. 20)...