Health campaigners last night urged doctors to be wary of prescribing an arthritis drug after concerns over its safety and an order to ban it in Australia following reports of liver damage. UK and European drug regulators are reviewing the safety data on the painkiller, Prexige, after eight cases of serious liver damage in Australia, including two fatalities.
There are concerns because Prexige is in the same class of drugs as Vioxx, the painkiller withdrawn worldwide in 2004 after being linked to heart attacks and strokes.
Jane Tadman of the Arthritis Research Campaign said: "Doctors should be wary of prescribing this drug. Any patient who is worried should see their doctor."
The UK medicines watchdog said it received 16 reports of adverse reactions in people on the drug since March 2006; one involved a liver reaction. But it stressed the daily dose prescribed to most of the patients in Australia was double the 100mg dose routinely prescribed in the UK.
In the UK approximately 5,400 patients have received one or more prescriptions for Prexige, made by the drugs company Novartis, in the last year.
Vioxx, which was manufactured by a separate drugs company, Merck, was used by 84 million patients worldwide, 400,000 of them in Britain. It was withdrawn after trials suggested it might nearly double the risk of heart attacks and strokes.
The class of drugs which includes Prexige and Vioxx is known as Cox-2 selective inhibitors. They are a relatively new type of anti-inflammatory medicine which is thought to produce fewer gastro-intestinal side effects than older non-steroidal anti-inflammatory drugs, which include ibuprofen. Since the Vioxx crisis they have been under surveillance by medicines watchdogs. The European Medicines Agency ruled on the cardiovascular effects of Prexige and two other Cox-2 drugs in 2005 when it was decided that the labelling would be revised to ensure doctors did not overprescribe or prescribe to vulnerable groups. A spokesman for the Medicines and Healthcare products Regulatory Agency said any concerned patient should contact their doctor.
A spokesman for Novartis said: "The cases cited in Australia involved treatment mostly with the 200mg dose of Prexige, while one case involved the 400mg dose." Australia was the only country where 200mg once-daily tablets were available. This was now 100mg to match the rest of the world.