Prexige pulled from UK market
pharmafile | November 20, 2007 | News story | Sales and Marketing | prexige
Novartis' Prexige has been taken off the market and UK doctors instructed to immediately stop prescribing it following several instances of serious liver-related side effects.
UK regulator the MHRA suspended Prexige's licence after a review of worldwide patient data linked the arthritis pain drug to serious hepatotoxicity, with two suspected cases resulting in death.
The MHRA said the side effect occurred after less than a month of treatment with Prexige (lumiracoxib) in some cases, and that urgent action was required to protect public health.
"Ideally, patients should stop taking lumiracoxib straight-away, but it would be acceptable to continue treatment until the next convenient appointment," the regulator said in a statement.
Prexige has also been suspended in Germany, and other EU countries may follow suit before European regulators make a decision – expected in December – on the drug's safety.
Worldwide some 160 adverse reactions to Prexige were reported earlier this year, with 91 considered serious, and in August Novartis wrote to healthcare professionals to advise them of new prescribing restrictions.
The data also triggered further reviews by UK and European regulators, and MHRA advisors concluded that even monthly liver function checks on patients would not guarantee safety.
Novartis said in a statement: "[We continue] to believe Prexige is an important treatment option with a positive benefit/risk ratio when used in appropriate patients.
"[We] will continue discussions with European health regulators, and with the US Food and Drug Administration following its decision in September 2007 not to approve Prexige, to determine how to make this treatment option available to appropriate patients."
The company maintains the deaths were caused by patients taking a higher than recommended dose of the Cox-II painkiller.
But Prexige was withdrawn from the Australian market in August after a number of liver side effects were reported, including two deaths, associated with the use of Prexige at doses higher than its approved 100-mg dose.
Prexige is a relatively new anti-inflammatory treatment for osteoarthritis pain and is thought to have less gastrointestinal side effects than its predecessors.
Since 2005, it has been approved in over 50 countries and written for around 8.5 million prescriptions.
Prexige sits in same class of treatment as Vioxx, the painkiller that has cost its manufacturers Merck billions of dollars in compensation to US patients who suffered heart problems or strokes as a reaction to the treatment.
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