The suspensions were announced after the Committee for Medicinal Products for Human Use (CHMP) initiated ‘Article 107’ procedure on November 16, 2007. This occurs when an EU member state withdraws, suspends or changes the status of a nationally authorized medicine after a review of safety data. This enables the CHMP to prepare an opinion as to whether the regulatory action should apply throughout the EU.
The latest analysis of patients taking the Prexige 100mg dose showed nine severe hepatic events reported worldwide. 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 (NSAIDs).
The actions in Europe come after an urgent safety restriction was initiated in August 2007 for the Prexige 100mg dose. Novartis worked with European regulators to update prescribing information, including additional warnings and precautions about liver monitoring for patients. Prexige was first withdrawn in August 2007 in Australia where a number of liver side effects were reported, including two deaths, associated with the use of Prexige at doses higher than 100mg. No deaths have been reported worldwide with the 100mg dose.
Novartis will also comply with a request from the Austrian health authority to suspend sales pending a final decision by the CHMP, which reviews medicines in the EU.
Prexige is available in some European countries as a 100mg once-daily treatment for osteoarthritic pain following EU approval through the mutual recognition procedure in October 2006, with the UK as the reference member state. Prexige is also marketed and sold in Belgium, Cyprus, Hungary, Malta, Portugal and Sweden.