Australia Forces Novartis To Withdraw Prexige
2 CommentsBy Ed Silverman // August 11th, 2007 // 9:10 am
The government took action after two deaths and two liver transplants, among eight serious reactions, were suffered by people who took the painkiller. Australia’s Therapeutic Goods Administration cited concerns over liver damage for cancelling the drugmaker’s registration for the med, which was referred to as Lymiracoxib in the official statement. Like Vioxx, which was withdrawn in 2004 by Merck over links to heart attacks and strokes, Prexige is a Cox-2 inhibitor.
“The TGA and its expert advisory committee, the Adverse Drug Reactions Advisory Committee, have urgently investigated these reports. ADRAC has today recommended the cancellation of the registration of Lumiracoxib due to the severity of the reported side effects associated with this drug,” said Rohan TGA’s principal medical adviser. “It seems that the longer people are on the medicine, the greater the chance of liver injury. The TGA is, therefore, advising people to stop taking the Lumiracoxib immediately and to discuss alternative treatments with their doctor.”
In a statement issued only on its Australian web site, Novartis noted Prexige has been withdrawn, but argued “serious liver side effects have been reported rarely for all Cox-2 inhibitors and traditional NSAIDs (non-steroidal anti-infllamatories). Novartis estimates that approximately 60,000 patients have used Prexige in Australia, and the majority of these have been prescribed Prexige 200 mg for the management of osteoarthritis. Prexige was first made available to patients in Australia in November 2005.”
More than 7 million prescriptions for Prexige have been issued worldwide since the drug was launched in July 2005, and health authorities in 50 countries where the drug is sold were notified of the withdrawal, Bloomberg News reports. John Gilardi, a Novartis spokesman, declined to tell Bloomberg whether there are plans to withdraw Prexige from other markets. Most of the cases were for 200mg doses, while one was for 400mg, higher than recommended. The 100mg wasn’t linked to any of the cases.
Novartis also noted that liver failure is a “known rare, but serious, side effect”‘ of the Cox-2 inhibitors. Of course, this is more likely going to make it difficult for Novartis to convince the FDA to approve Prexige for use in the US. Novartis delayed the introduction of the drug after the Vioxx withdrawal and was planning to resubmit its application this year.
Hypocrisy rules
There have been several comments re this drug and how it relates to Vioxx. In fact this writer has worned about this new Vioxx immediately after its intro into the first country and especially after it hit the N. American markets. The drug itself may not be as bad as reported here but what is wrong Novartis’ promotion to every doc and to every patient with OA. This drug has a very limitted and narrow indication, OA of the knees, period.
Does anyone in their right mind think that Novartis with their multiple sales forces for specialists and GPs would limit the promo of their Vioxx to its narrow indication? Not bloody likely.
When you have thousands upon thousands of inocent patients/people on the drug like this one without good and right reason you are likely to see these side effects.
On personal note. I was Rxed Prexige by my GP for the pain in my shoulder. Did nothing for me so I luckily stopped and switched to ASA with complete success. My doctor was told by the reps ( yes plural) thagt it was OK to Rx it to anyone with pain of OA.
Off label, false claim you take a pick. It never stops with these “people”.
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