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Cox-2 inhibitors, dubbed "super aspirin", have been under a cloud since a popular painkiller Vioxx was withdrawn in 2004 for increasing the risk of cardiovascular disease.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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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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