Part 6: Australia: Killing 2 Patients with Prexige

Australia's drugs regulator has banned the use of Prexige, a painkiller made by Swiss pharmaceutical giant Novartis, after the deaths of two patients.

After 8 reports of serious liver damage--including two deaths and two liver transplants linked to the use of Novartis' COX-2 painkiller, Prexige (Lumiracoxib), Australia's drug regulator has banned its use. The drug is currently approved in 50 countries and Novartis plans to file with the FDA for a marketing license later this year.

The case, once again, underscores the inconsistent, financially-driven drug approval criteria used to approve new drugs for marketing. The process results in consumers' lives being put at risk.

Australia's Therapeutic Goods Administration (TGA) said it had received eight reports of serious liver side effects - including two deaths and two liver transplants - linked with the use of the drug, also known as Lumiracoxib.

Prexige had initially been seen as a blockbuster seller for Novartis, but analysts' expectations collapsed after the Vioxx withdrawal, and there were doubts whether Prexige would ever win US approval.

Novartis has been plagued by a number of drug setbacks this year, delaying the launch of its diabetes drug Galvus because of safety concerns, and also evaluating the launch of a generic version of its Lotrel blood pressure treatment.

August 12, 2007


 http://ahrp.blogspot.com/2007/08/australia-bans-novartis-cox-2.html