UK, Germany Stop Sales of Prexige

Healthcare regulators in the UK and Germany have suspended marketing and sales of Novartis’ Prexige due to concerns about an increased risk for liver damage.

Recent worldwide data show an increase in the number of serious liver reactions occurring with the 100-mg dose of Prexige (lumiracoxib), including in patients taking the drug short-term, the UK’s Medicines and Healthcare products Regulatory Agency said.

Health regulators in Austria also asked the company to suspend sales of the Cox-2 inhibitor pending a review by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP).

Earlier this year, the FDA issued a not-approvable letter to Novartis for Prexige for the treatment of osteoarthritic pain.

Canada suspended sales and marketing of Prexige after the drug was withdrawn from the Australian market. Australian reports of serious liver adverse events were linked with 200- and 400-mg doses of the drug.

Before the CHMP issues its opinion, other European Union member countries can independently decide to suspend marketing of Prexige. The committee is expected to issue its opinion in December.