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Press Realease: Medicines Regulator cancels registration of anti inflammatory drug, Lumiracoxib
11 August 2007
Quote:
Australia's medicines Regulator, the Therapeutic Goods Administration (TGA) has cancelled the registration of the osteoarthritis drug, Lumiracoxib because of serious liver side effects associated with the use of the drug.
Lumiracoxib, marketed by Novartis Pharmaceuticals under the brand name of Prexige, is a Cox 2 inhibitor belonging to the group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDS).
Lumiracoxib was first approved in Australia in July 2004 but has only recently become widely used since being listed on the Pharmaceutical Benefits Scheme (PBS) in 2006.
According to the TGA's Principal Medical Adviser, Dr Rohan Hammett, as of 10th August 2007 the TGA had received 8 reports of serious liver adverse reactions to the drug, including two deaths and two liver transplants.
"The TGA and its expert advisory committee, the Adverse Drug Reactions Advisory Committee (ADRAC), 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," Dr Hammett said.
"The TGA has taken this advice to cancel the registration of Lumiracoxib in order to prevent further cases of severe liver damage.
"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," Dr Hammett said.
Approximately 60 000 people take Lumiracoxib in Australia which is typically prescribed for: symptomatic relief in the treatment of osteoarthritis, relief
Novartis Australia have just released a statement:
MEDIA RELEASE
SATURDAY AUGUST 11 2007 Novartis withdraws Prexige® (lumiracoxib) in Australia in response to decision from Therapeutic Goods Administration (TGA)
Quote:
Novartis Pharmaceuticals Australia has complied with the decision of the TGA to withdraw all doses of Prexige, a Cox-2 inhibitor for the treatment of osteoarthritis and acute pain, with immediate effect. This action has been taken after a number of cases of serious liver side effects were reported in Australian patients taking Prexige, including two deaths and two liver transplants. Serious liver side effects have been reported rarely for all Cox-2 inhibitors and traditional NSAIDs.
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.
Patients in Australia who are taking Prexige should stop taking the treatment immediately and contact their doctor to seek advice on alternative medications.
Patients should return any remaining Prexige tablets to their pharmacist, who will give the patient a full refund. A helpline has been established for patients who have any queries in relation to this withdrawal of Prexige. The number is 1800 671 203 (8.30am – 8.30pm). Novartis is alerting healthcare professionals, patients and patient groups in Australia about the decision and will be informing relevant health authorities around the world about the withdrawal.
The Australian Medical Association have now weighed in: Calm urged over anti-inflammatory drug deaths
Quote:
The Australian Medical Association (AMA) is warning people not to panic after two people died from the side effects of an anti-inflammatory drug.
The drug Lumiracoxib, which is sold as Prexige, has been recalled by the Therapeutic Goods Administration after reports that two people had died and another two needed a liver transplant.
Prexige has been prescribed to 60,000 Australians for osteoarthritis or pain relief after surgery for the past two years.
The AMA's John Gullotta says liver damage is not a common side effect of the drug.
"The important thing is to stress to people not to panic, if they are taking the medication to stop the medication, to see their doctor for alternate medications and for people who've got remaining tablets they can return them to their pharmacists for a refund," he said.
ABC are reporting: Govt quizzed over arthritis drug deaths
Quote:
New South Wales acting Minister for Health John Hatzistergos says the Federal Government has many questions to answer about why the drug Lumiracoxib was ever allowed to be sold in Australia.
The Therapeutic Goods Administration (TGA) suspended the registration of the osteoarthritis medication Prexige, after two people died and two others await liver transplants.
The Australian Medical Association (AMA) is warning people not to panic, but Mr Hatzistergos says it never should have happened.
"It seems remarkable that we've had this sort of outcome, when this drug was placed on the Pharmaceutical Benefits Scheme in August of last year and went on sale in Australia in November 2005," he said.
"The questions the Government needs to answer is why the TGA allowed this drug to be placed on the market and why they placed it on the Pharmaceutical Benefits Scheme."
Is this just affecting Australia? I can't find any notice for the UK.
I have checked all the usual sources and no other country have acted on this yet. In fact the, this is from only two weeks ago in Canada:
Quote:
Health Canada expands use of new COX-2 inhibitor
Prexigenow available to patients suffering from osteoarthritis in any joint
DORVAL, QC, July 25 /CNW/ - Novartis Pharmaceuticals Canada Inc. announced today the expanded Health Canada approval of Prexige lumiracoxib) for the acute and chronic treatment of the signs and symptoms of osteoarthritis (OA) in adults. Initially approved for OA of the knee in November 2006, Prexige is a unique selective COX-2 inhibitor that provides osteoarthritis patients with an effective and safe option for controlling pain, improving their mobility and quality of life....
Just returned from the ACPS conference in Adelaide, where one of the presenters was Professor Lloyd Sampson, who is a member of the PBS advisory committee here in Australia. A fantastic speaker and supporter of podiatric surgery.
He also raised this on Saturday, and in a politically correct manner, predicted that this was now likely to be the final nail in the coffin for COX-2 inhibitors worldwide. It will be unlikely that government bodies will now dare take a risk in allowing these products back on the market, and it would have to be a real miracle pill with over-the-top clinical evidence to convince governments otherwise.
Goodbye COX-2's; and back to naprosyn, ibuprofen and the like.
Whilst the deaths that have been reported following use of COX-2 inhibitors are tragic, the reaction of the regulators, drug manufacturers and lawyers are possibly even more so. We'll now never know the exact risk of liver disease that this drug causes, and this denies many patients with chronic pain the opportunity for a better quality of life. In a calmer, less litigious world, patients could make an informed choice as to whether they were willing to accept the small risks associated with a treatment in return for the overwhelming benefits it offered. Just look at the massive class actions against Pfizer when Vioxx was pulled - everyone now wants a risk-free life and there's plenty of lawyers willing to fight their cause if things go wrong.
I'll get off my soapbox now - that was a bit of a rant for a Monday morning :)
Another cox-2 withdrawn
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