Regulatory agencies reinforce COX-2 safety advice
Main amendments to advice
· The existing contraindication for severe heart failure has been
extended to include moderate heart failure
· Periodic re-evaluation is recommended, especially for osteoarthritis
patients who may only require intermittent treatment
· Etoricoxib treatment should not be initiated in patients whose
hypertension is not under control. Careful monitoring of blood
pressure is advised for patients taking etoricoxib |
Recent advice on the safety of selective cyclo-oxygenase-2 (COX-2) inhibitors issued by UK and European drug regulators has been updated following a review of available data.
There are no major changes to the advice; rather, the earlier precautionary
advice has been reinforced. The move follows publication of three major
trials that raised concern about the safety of these drugs. The Panel
lists the main amendments to the advice.
Rofecoxib (Vioxx) was voluntarily
withdrawn from the market by Merck
Sharp & Dohme last year (PJ, 9 October 2004, p505) following the
APPROVe (adenomatous polyp prevention in Vioxx) study, which found an
increased risk of heart attack and stroke after 18 months of treatment.
The study was published online last week and confirms that the relative
risk of developing a thrombotic event after 18 months of treatment with
the drug was 1.92 (95 per cent confidence interval, 1.19–3.11,
P=0.008) (New
England Journal of Medicine).
Also published are the results of the trial that prompted the Medicines
and Healthcare products Regulatory Agency to issue advice that all patients
taking a coxib and at risk of stroke should have their medicine
reviewed (PJ, 1/8 January, p4). The APC (adenoma prevention with celecoxib) trial
found that celecoxib use was associated with a dose-related increase
in death from cardiovascular events.
The third study published last week shows that, when used in patients
who have had a coronary artery bypass graft, parecoxib and valdecoxib
are associated with increased rates of cardiovascular events.
The MHRA says that the overall risks and benefits of selective COX-2
inhibitors will continue to be closely reviewed and that new advice will
be issued when necessary.
A questions and answers sheet for patients taking the drugs is available
on the MHRA website and can be accessed as a PDF file (25K). |
The
Pharmaceutical Journal
Acrobat
Reader