Regulatory

Australia bans Novartis's Prexige on liver worries

Last Updated: 2007-08-13 14:44:12 -0400 (Reuters Health)

By Douwe Miedema

ZURICH (Reuters) - Australia's drugs regulator banned the use of Novartis's Prexige because of liver problems in patients using the painkiller, the watchdog said, including two deaths and two liver transplants.

The country's Therapeutic Goods Administration (TGA) had received eight reports of serious liver side effects associated with the use of the drug, also known as lumiracoxib, which was approved for use in Australia in July 2004.

"It seems that the longer people are on the medicine, the greater the chance of liver injury. The TGA is, therefore, advising people to stop taking the lumiracoxib immediately," the TGA said in a statement on Saturday.

Novartis would comply with the authorities, a spokesman said, but it continued to believe the drug had a positive benefit/risk profile in the treatment of patients with osteoarthritis and acute pain.

Prexige, which had modest sales of $52 million in the first half of the year, is approved in more than 50 countries, and is currently being rolled out in Europe.

There were no plans to pull the drug elsewhere, the spokesman said, and the company would also proceed to file the drug for marketing approval in the United States.

Liver failure was a rare, but known, side effect of all COX-2 inhibitors, as well as of other non-steroidal anti-inflammatory drugs (NSAIDs), the spokesman said.

COX-2s have been under a cloud since Merck & Co. Inc withdrew Vioxx in 2004 after studies found it raised the risk of heart attack. There have also been worries about other NSAIDs.

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