We can't do without her
GPs face further restrictions on their use of cox-2 inhibitors after the release of the European Medicine Agency's long-awaited final judgment on the drugs.
The EMEA added peripheral arterial disease to a list of contraindications that already included ischaemic heart disease and cerebrovascular disease (see box, below).
The agency also strengthened warnings on hypersensitivity reactions and said 'rare, but serious and sometimes fatal, skin reactions' could occur with all cox-2s.
The UK's Medicines and Healthcare Products Regulatory Agency said it would update its own advice as soon as the EMEA recommendations were confirmed by the European Commission.
But GPs warned that the ruling could leave them with a serious hole in their prescribing options.
Dr Iain Gilchrist, treasurer of the Primary Care Rheumatology Society and a GP in Bishops Stortford, Essex, said: 'When you are dealing with patients who may have, not a fatal condition, but nonetheless quite severe morbidity, many of them are going to say "I'll take my chances doctor".'
Dr Jim Kennedy, RCGP prescribing spokesman, called the ruling an 'adequate response'. But he said safety reviews should not restrict themselves to a single drug class and should examine benefits as well as risk.
'There is a danger we could have a very restricted range of drugs available to us to treat the worst-affected patients in these areas,' he warned.
The EMEA also decided formally to suspend valdecoxib (Bextra) for at least a year, following its voluntary withdrawal by Pfizer in April.
The agency's Committee for Medicinal Products for Human Use is now examining the safety profile of NSAIDs in general, to 'determine the need for further steps'.
Dr Gilchrist said he hoped the cox-2 controversy would act as a catalyst for a general reform of drug surveillance.
'The system of surveillance really needs a tremendous shake-up,' he said. 'It is no longer viable to rely on a system devised in the wake of thalidomide 40 years ago.'
By Daniel Cressey
EMEA ruling on cox-2s
·Valdecoxib (Bextra) suspended for at least a year, pending further evidence on benefits
·Cox-2s must not be used in patients with established ischaemic heart disease, cerebrovascular disease and/or peripheral arterial disease
·Warning on cautious use in patients with risk factors for heart disease
·Warning on risk of hypersensitivity and skin reactions
·Doctors advised to use lowest effective dose for shortest possible duration of treatment