Australian Lawyers Question Discrepancies Surrounding The Use Of Prexige

Lawyers have questioned why the banned drug Prexige was available in Australia at higher doses and with fewer warnings than in other countries.
Product liability law firms have started fielding calls from patients claiming to have suffered serious side-effects on the osteoarthritis painkiller urgently withdrawn one week ago.
The Therapeutic Goods Administration (TGA) pulled Prexige after receiving eight reports of liver damage, including two deaths and two patients who required liver transplants.
About 60,000 Australians have taken Prexige since it was registered in November 2005, with most prescribed after it joined the Pharmaceutical Benefits Scheme last August.
Most were on the controversial 200mg dose - double the dose recommended in other countries - and all eight cases under investigation involved 200-400mg doses.
Brisbane-based law firm Nicol Robinson Hallets, which has received legal queries from Prexige patients, said high dosing and poor warnings had put Australians at increased risk.
"We want to know why the TGA was allowing prescriptions to be authorised at 200mg and more," said lawyer Simon Harrison.
"There are 50 countries in the world that have approval for Prexige and only 15 actually sell it, and not one of those 15 countries have a dosage that's in excess of 100mg, so why did we?"
Mr Harrison also said Australia's Prexige pack labels contained none of the liver damage warnings included in other nations.
"In the UK, for example, the warning labels make four separate references to potential liver damage," he said.
"But warnings handed out on prescription labels here contain no reference to liver damage at all."
Mr Harrison said these discrepancies would strengthen the legal case for patients suffering adverse effects from the drug.
Bill Madden, head of medical negligence action at law firm Slater and Gordon, said the company had received at least four calls from patients "very severely affected" by the drug.
He expected numbers to grow over the next month as people return to their doctors to get liver function tests.
"There may some form of a claim under the Trade Practices Act against the manufacturer or the distributor," Mr Madden said.
"And there may also be some broader negligence claims, but they will depend a lot on what the manufacturer knew about these effects and whether the warnings were adequate."
Mr Harrison said the legal case would bear some similarities to another disgraced drug in the problematic Cox-2 inhibitor family, Vioxx, which was linked to cardiac problems.
However, the Prexige case was more straightforward because liver problems, unlike heart problems, were usually only triggered by alcohol abuse or genes, he said.
The TGA did not respond to media queries on Prexige dosage and warnings.

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Painkiller Prexige Recalled In Australia

A PAINKILLER used by 60,000 Australians has been ordered off the shelves after the deaths of two people.

The Therapeutic Goods Administration yesterday announced the urgent recall of the drug Prexige, used to treat osteoarthritis and acute pain. Patients using the drug, also known by its chemical name lumiracoxib, are advised to stop taking it immediately and ask their doctor for an alternative prescription.

The TGA made the decision after receiving reports of eight people who suffered serious liver reactions, including two deaths and two liver transplants. Six of the reports occurred since the beginning of July.

TGA medical adviser Rohan Hammett said in a statement yesterday the drug was being recalled to prevent further cases of severe liver damage.

"It seems that the longer people are on the medicine, the greater chance of liver injury," Mr Hammett said.

Australia is the first country in the world to withdraw the drug, which is produced by Novartis Pharmaceuticals. Novartis estimates the drug has been used by about 60,000 Australians.

It is not yet known whether the 50 other countries that sell the drug will follow suit. Prexige is still awaiting approval by the US Food and Drug Administration.

Prexige went on sale in Australia in November, 2005 and gained widespread use since being listed on the Pharmaceutical Benefits Scheme in August last year. At the time, patients were warned to exercise caution with Prexige because it belonged to a family of drugs known as Cox-2 inhibitors linked with heart attack and stroke.

Cox-2 inhibitors, dubbed "super aspirin", have been under a cloud since a popular painkiller Vioxx was withdrawn in 2004 for increasing the risk of cardiovascular disease. Australia's National Prescribing Service - an independent, government-funded agency that advises doctors about the safe use of medications - warned last year that not enough was known about the long-term safety of Prexige.

Novartis spokeswoman Rebecca Fisher-Pollard urged people who used the drug not to panic. She said liver damage was known as a possible side effect but the incidence was rare.

"The information has always been there," Ms Fisher-Pollard said.

Novartis has set up a patient helpline to answer queries. Patients are advised to return any unused Prexige tablets to their pharmacist, who will give them a full refund. All GP groups and pharmacists have been alerted about the drug recall.

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