On September 12, 2007, Novartis AG chief executive Daniel Vasella said he does not expect the company’s new painkiller, Prexige, will be approved for use in the United States.

“If you want my personal opinion, I don’t expect we’ll get approval,” Vasella said.

Prexige is a painkiller predominantly marketed for osteoarthritis pain, but is also used for post-operative pain and painful menstruation. Prexige is a COX-2 inhibitor, belonging to the same class of drugs as Vioxx, a drug recalled in 2004 after it was connected to sudden cardiac deaths.

In August 2007, Australia’s Therapeutic Goods Administration (TGA) – the country’s equivalent to the U.S. Food and Drug Administration (FDA) – urgently recalled Prexige after receiving eight reports of liver damage, including two deaths and two patients who required liver transplants. About 60,000 people are believed to have been prescribed Prexige.

Several weeks later, New Zealand’s drug regulatory authority, Medsafe, cancelled the availability of 200- and 400-mg tablets of Prexige after reviewing the reports from Australia. The 100-mg tablet remains on New Zealand’s market, but the safety of the drug will continue to be closely monitored by Medsafe.

“This increased risk of liver damage for Prexige outweighs any of the potential benefits claimed for the 200-mg and 400-mg dose,” said Stewart Jessamine, Medsafe’s interim manager.

Also in response to Australia’s recall, the Arthritis Research Campaign – the United Kingdom’s medicines watchdog – urged doctors to be cautious in prescribing Prexige. The group said it received 16 reports of adverse reactions in patients since March 2006, one involving a liver reaction.

“Doctors should be wary of prescribing this drug,” said Jane Tadman, spokesman for the Arthritis Research Campaign. “Any patient who is worried should see their doctor.”

Sources: Anita Greil, “US unlikely to approve Novartis drug,” Wall Street Journal, September 13, 2007; “Prexige recall sparks calls to hotline,” The Age, August 21, 2007; “High-Dose Prexige Withdrawn in New Zealand ,” FDAnews drug daily bulletin, August 31, 2007; Polly Curtis, “Doctors warned over arthritis drug after two die in Australia,” The Guardian, August 16, 2007.