Pharmaceutical News - August 2007
Campaigners Highlight Arthritis Drug's Safety Hazards
Posted by Paul Fiddian on 16/08/2007 - 18:25:26
On Wednesday 15th August 2007, a warning from health campaigners focused on the risk element of Prexige - an arthritis drug. They urged that doctors exercise caution when prescribing the painkiller, in light of recent concerns regarding its safety. Prexige was recently prohibited in Australia, where it has been linked to complications of the liver - two patients having died, within a group of eight affected. The drug is now being assessed by regulators in the UK, and across Europe.
A prime concern is that both Prexige and Vioxx occupy the same class of drug - the so-called Cox-2 selective inhibitors. These are comparatively new in conception; anti-inflammatory products designed to induce less in the way of gastro-intestinal reactions than their precursors (such as ibuprofen). In the aftermath of the Vioxx scandal, Cox-2 selective inhibitors have been monitored closely.
Two years ago, a ruling was issued by the European Medicines Agency in respect of Prexige. Within this, it was decreed that the drug's labelling be amended to make sure that, in the hands of doctors, it would not be prescribed in certain situations.
Vioxx itself was banned worldwide three years ago, after a connection with an increased risk of strokes and heart attacks was found.
One of the campaigners behind the new warning is the Arthritis Research Campaign's Jane Tadman, who stated: "Doctors should be wary of prescribing this drug", adding: "Any patient who is worried should see their doctor."
Since 2006, the UK medicines watchdog said, 16 people have reported Prexige having produced extreme side effects, of which one was connected to the liver. It emphasised, however, that, in Australia, patients there were routinely prescribed twice the amount administered to people with arthritis in this country
A spokesman from Novartis, the manufacturer of Prexige said: "The cases cited in Australia involved treatment mostly with the 200mg dose of Prexige, while one case involved the 400mg dose." Australia is the sole country in the world where Prexige was offered in 200mg tablets.
Over the past 12 months, it has been prescribed, at least once, to around 5,400 UK arthritis sufferers.
Source - Pharmaceutical International's Regulatory Analyst
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