Halted celecoxib trial brings new prescribing advice
Patients who are being treated with celecoxib (Celebrex), valdecoxib
(Bextra) or etoricoxib (Arcoxia) and who have heart disease or are at
risk of stroke should have their treatment changed, says the Medicines
and Healthcare products Regulatory Agency (PDF 25K).
The advice follows suspension of a clinical trial examining the use of
celecoxib as a cancer prevention agent. Data from the trial showed that
a 400mg dose of celecoxib was associated with a 2.5-fold increased risk
of major cardiovascular events compared with placebo.
The MHRA has recommended that all patients taking one of these medicines
should make an appointment with their GP to have their treatment reviewed.
Patients with established ischaemic heart disease or cerebrovascular
disease should be switched to an alternative, non-coxib treatment. For
all other patients alternative treatments should be considered dependent
on an individual assessment of the risks and benefits.
The new advice relates only to celecoxib, etoricoxib and valdecoxib.
It does not apply to meloxicam (Mobic) or etodolac (two other cyclo-oxygenase-2
[COX-2] selective inhibitors).
A spokeswoman for the Department of Health explained that this is because
meloxicam and etodolac are not as highly selective as other COX-2 inhibitors. “Recent
cardiovascular safety concerns have related to the ‘coxib’ class,
and it is plausible that the degree of COX-2 selectivity may have an
important influence on the cardiovascular safety profile of these drugs.”
Gordon Duff, chairman of the CSM, said: “The Committee on the Safety
of Medicines is waiting for the study data. Once this is available the
Committee will carefully consider this and issue further advice”.
Meanwhile, the European Medicines Agency (EMEA) has also issued recommendations
concerning the use of valdecoxib and parecoxib sodium (Dynastat) following
reports of cardiovascular and serious skin adverse events (PDF 420K).
Two clinical studies have suggested that patients treated with these
agents following coronary artery bypass graft surgery have a higher rate
of serious cardiovascular thromboembolic events. And post-marketing reports
indicate that valdecoxib (and to a lesser extent parecoxib) may be associated
with serious skin reactions.
The agency therefore states that valdecoxib and parecoxib are contraindicated
in patients following coronary artery bypass graft surgery. It adds that
any patient who develops skin rash, mucosal lesions or signs of hypersensitivity
should discontinue treatment immediately. |
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