Novartis announces Prexige sale suspension

Novartis has announced that the marketing and sale of Prexige (lumiracoxib) in the UK and Germany has been suspended, with EU regulators initiating the Article 107 procedure to assess the benefit and risk profile of the compound.

The company is informing other regulatory bodies worldwide of this change, while continuing its dialogue with health authorities and maintaining the view that Prexige is a useful treatment option for some patients experiencing osteoarthritic pain.

Novartis reports that it will also act in accordance with a request from the Austrian health authority to halt sales of the drugs until a decision is made by the Committee for Medicinal Products for Human Use.

“The latest analysis of patients taking the Prexige 100 mg dose showed nine severe hepatic events reported worldwide,” the company said.

“This corresponds to a rate of 5.19 events per 100,000 patient-years, which is within the rate expected for [non-steroidal anti-inflammatory drugs].”

Novartis has advised patients in Austria, Germany and the UK taking the compound to to consult their healthcare provider.

Prexige was first recalled in Austria in August 2007 following reports of connections to serious side effects in patients receiving the drug.