The UK (United Kingdom) Medicines and Healthcare Products Regulatory Agency (MHRA) reported that Novartis Pharmaceuticals AG has informed doctors in Europe of new restrictions on prescribing its COX-2 anti-inflammatory osteoarthritis (OA) drug Prexige® (lumiracoxib), including regular liver function monitoring both before and during treatment. Novartis also said Prexige should not be used in patients who either currently have liver disease, are at possible risk because of previous liver problems with other medicines, or are taking other medications that could potentially cause liver problems. These new restrictions were communicated by Novartis following consultation with MHRA and other European regulators. Concern was raised worldwide after reports of rare but serious liver reactions, most of which related to daily doses that are higher than licensed in the EU. The balance of risks and benefits of lumiracoxib in the treatment of OA will be further evaluated by European regulatory authorities in September. Any updated advice will be issued following that evaluation.

According to physician data collected thus far via MHRA's Yellow Card Scheme, there have been 16 reports of suspected adverse reactions to lumiracoxib in the UK since March 2006. One of these suspected adverse reactions was a liver reaction that resolved after treatment with lumiracoxib was stopped. In the UK, the MHRA has not had any reports of fatal adverse reactions to lumiracoxib. Approximately 5400 patients have received one or more prescriptions for lumiracoxib in the last year.

The MHRA stated that worldwide there have been 11 cases of severe liver reactions, including nine cases of liver failure, two deaths, and three liver transplants suspected to be related to use of the drug. These cases were mostly related to doses >100 mg than used in the UK and elsewhere in the EU. Over 7 million patients worldwide are estimated to have taken lumiracoxib since it was launched in July 2005.

—A. Techman