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EU calls for stronger warnings on Cox-2 inhibitor prescribing

The EU drug safety watchdog has recommended new and stronger warnings on the use of Cox-2 inhibitors in patients with gastrointestinal and cardiovascular risks after reports of safety problems.

But primary care gastrointestinal experts have reassured GPs the warning should not alter their prescribing practice for NSAIDs.

After an EU-wide review of Cox-2 inhibitors celecoxib, etoricoxib, parecoxib, rofecoxib and valdecoxib, prompted by French safety concerns, the Committee for Proprietary Medicinal Products concluded that the drugs caused less harm than good for target


However, the committee recommended the European Commission should order stronger warnings be added to the drugs' licences, recommending caution for patients with underlying gastrointestinal and cardiovascular risks.

The EU recommendation strengthens warnings from the National Institute of Clinical Excellence in its 2001 guidance on the use of Cox-2 inhibitors that the use of the drugs should be considered 'especially carefully' in patients with GI risks and should not be prescribed on a regular basis to patients with cardiovascular disease.

But the NICE guidelines state that Cox-2s should be prescribed to high-risk patients instead of standard NSAIDs and the Primary Care Rheumatology Society says Cox-2 inhibitors remain safer than standard NSAIDs for patients with high risk of serious GI problems.

To date the Medicines and Healthcare products Regulatory Agency has received 5,884 yellow card reports on these Cox-2 inhibitors, including 57 fatalities from suspected GI adverse reactions.

Dr Graham Davenport, chair of the society and a GP in Nantwich, Cheshire, said: 'Cox-2s are still safer than standard NSAIDs for GI adverse events but in terms of cardiovascular disease and renal function they are no different.'

Dr Davenport added that problems with GPs continuing to prescribe regular NSAIDs to high-risk patients had been ironed out.

GPs had flouted NICE guidelines on prescribing Cox-2 inhibitors because of worries over the price of the drugs, which are twice as expensive as regular NSAIDs, but Dr Davenport said PCTs now appreciated the cost benefit of having fewer patients suffering side-effects of regular NSAIDs.

NICE said the EU's review of Cox-2s would be taken into account in revised guidelines.

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