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).

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.

Data show that taking 100-mg doses of Prexige daily is not associated with increased liver risk compared with other nonsteroidal anti-inflammatory drugs (NSAIDs), Novartis said. A recent analysis of patients taking 100-mg doses of Prexige showed a rate of 5.19 severe events per 100,000 patient years, within the expected rate for NSAIDs. No deaths have been reported worldwide with the 100-mg dose.