GP steps in to keep solo practice open
The European Commission has stepped in to order a root-and-branch review of the safety of cox-2 inhibitors after a preliminary inquiry failed to give the drugs a clean bill of health.
But GPs are to be left without clear guidance indefinitely after the commission's drug watchdog refused to set a deadline for the review to be published.
The commission intervened in the licensing process after an initial review by the European Medicines Agency's Committee for Human Medicinal Products failed to rule out the possibility that a class effect was responsible for the excess cardiovascular risk that prompted the withdrawal of rofecoxib (Vioxx).
The committee will rule whether the cardiovascular risk from cox-2s outweighs the benefits and will consider four options: no change; changes to the SPCs; suspension of the licences of all cox-2s pending further trials; or withdrawal of the entire class of drugs from the market.
Dr Mark Wallace, a GP in Oxford with an interest in rheumatology, said the drugs were not irreplaceable. 'There is a reasonable alternative,' he said.
Dr Wallace said the rofecoxib withdrawal had left many GPs concerned over inadequate safety monitoring of new drugs. 'This may make me more cautious when prescribing new drugs.'
The new inquiry comes just four months after the last European review of cox-2s concluded the drugs had a positive overall risk-benefit profile.
Dr Chris Cates, a GP in Bushey, Hertfordshire, and a Cochrane Collaboration editor, said the news was worrying. 'Just because a drug is new, does it mean it is better?' he said.
The EMA said GPs should 'carefully follow the latest version of product characteristics, especially regarding warnings and precautions in patients with cardiovascular disease'.
In a further blow to confidence in the drugs, the US Government Accountability Office is to investigate the Food and Drugs Administration after allegations the agency tried to 'water down' findings of excess strokes and heart attacks in rofecoxib users.
More cox-2 inhibitor news
·MSD has moved to quell concerns by offering to reimburse patients for the cost of their final prescription of Vioxx or Vioxxacute. Patients should call 0800 106024 for details of how to receive the £6.40 refund.
·Pfizer announced last month that it would launch a new study to evaluate cardiovascular risks of celecoxib (Celebrex).
·MSD released the latest trial evidence on its drug etoricoxib (Arcoxia) at the recent American College of Rheumatology annual meeting. MSD's EDGE trial, which comprised 7,111 patients randomised to either etoricoxib 90mg or diclofenac 50mg for one year, found no significant difference in cardiovascular events.
·Pfizer has updated its US prescribing information on valdecoxib (Bextra) to include a warning about severe skin reactions. The EU ruled in June that these warnings should be included.
·Pfizer also advised that two studies comprising 1,500 patients found that those who underwent coronary artery bypass graft surgery were at increased risk of cardiovascular events if they took valdecoxib. The BNF already carries a caution on the use of the drug post-CABG surgery.
By Rob Finch