After a number of cases of serious liver damage in Australian patients taking Prexige (lumiracoxib), Novartis withdrew the drug in that country.
The move was requested by Australia’s regulator, the Therapeutic Goods Administration (TGA), which canceled the Prexige registration after receiving eight reports of serious liver side effects among those taking the drug. The adverse events included two deaths and two patients requiring liver transplants.
The Wall Street Journal quoted a Novartis spokesman as saying that there were no plans to pull the Cox-2 inhibitor in other countries, and that the firm still intends to file the drug for marketing approval in the US, although the TGA decision is likely to impact the outcome of the upcoming review.
“The TGA has taken this advice to cancel the registration of lumiracoxib in order to prevent further cases of severe liver damage,” said its principal medical adviser, Dr. Rohan Hammett, in a statement.
It said serious liver side effects are rare for Cox-2 inhibitors, as well as traditional NSAIDs. Merck pulled Vioxx from the market in 2004 due to an association with heart problems. Pfizer, whose Celebrex is the only such drug available to US patients, resumed DTC television advertising for the drug in April with a 150-second spot carefully describing the drug’s cardiovascular risks and benefits.
Prexige is only available in about 50 countries. Since its approval in Australia, it has been used by approximately 60,000 patients there, mostly the 200-mg dose for osteoarthritis. Australia is the only country where Prexige is available in the 200 mg. strength. A 100 mg. pill is available elsewhere.
According to a report in Bloomberg, Novartis said most of the adverse event cases were for the 200-mg dose, while one was for 400 mg., higher than recommended.
Prexige had sales of $52 million in the first half of 2007.
