New Zealand bans larger doses of arthritis drug Prexige, cites liver damage risk

New Zealand health officials imposed a ban Tuesday on the supply of high-level doses of the pain relief drug Prexige, which has been linked to an increased risk of liver damage.

Medsafe, New Zealand's medicine watchdog, said it had ordered the withdrawal of 200 milligram and 400 milligram doses of Prexige tablets, produced by Swiss pharmaceutical company Novartis AG.

The 100 milligram dose tablets would stay on the market, though their use would be closely monitored, the government agency said.

The anti-inflammatory drug was withdrawn in Australia after it was blamed for the deaths of two people and for triggering liver failure that required two others to have transplants.

Medsafe spokesman Stewart Jessamine said its medicines adverse reactions committee discussed the overall risks and benefits of the use of Prexige with regulators in Australia, Singapore and Britain.

It "concluded that the data for higher doses of lumiracoxib, the active ingredient in Prexige, support an association with liver damage that was greater than that seen for other anti-inflammatory medicines," he said.

"This increased risk of liver damage for Prexige outweighs any of the potential benefits claimed for the 200 milligram and 400 milligram dose," Jessamine said.

Sheldon Jones, a spokesman for Novartis in Switzerland, said, "We're continuing to work with the health authorities about the recent information."

"When you use the appropriate patient populations, this is a drug that has a positive benefit risk profile," he said, adding that "the alternatives with traditional pain killers is a significant problem."

Earlier this month, up to 60,000 Australians were warned to stop using the drug immediately.

Jessamine said only "a few thousand" New Zealanders were taking the drug, with only about 1,000 taking the 400 milligram tablets.

Between 500 and 600 people had bought the 100 milligram Prexige tablets in the past three months, he said.