Pharmaprojects R&D Pipeline News Feed
Marketing suspensions hit Novartis' lumiracoxib
29 Nov 2007
Marketing of Novartis' selective COX-2 inhibitor lumiracoxib (Prexige) has been suspended in Germany and the UK due to ongoing concerns about possible liver toxicity in patients on the 100mg daily dose. Lumiracoxib was first launched at the end of 2005 for the treatment of pain related to osteoarthritis of the hip and knee.
Thus far, there have been 20 reported cases of severe liver problems with lumiracoxib, including 14 of liver failure. Another 2 led to fatality and 3 required liver transplants. Liver enzyme changes are common and expected side-effects of COX-2 inhibitors and other NSAIDs; and Novartis has pointed out that current data supports an event rate of 5.19 per 100,000 patient-years for lumiracoxib compared with a rate of between 3.1 and 23.4 for other NSAIDs, putting it within the expected boundaries.
However, the clock may be ticking for lumiracoxib: marketing was suspended in Austria, it has been withdrawn in Australia, and New Zealand withdrew the 200 and 400mg doses. Turkey has suspended authorization for the 100mg dose pending further review and Canada has withdrawn the authorization for this dose also. In September, the drug received a non-approvable letter in the US due to hepatic safety concerns and Aruba withdrew its product licence for all doses.
