Co-proxamol withdrawal is widely welcomed
Co-proxamol caused 400 deaths a year |
Letter to healthcare professionals PDF (55K)
Review outcome PDF (15K)
Question & answer PDF (25K)
Department of Health press
release |
Pharmacists have welcomed the decision by health safety regulators to withdraw the prescription painkiller co-proxamol. However, the Royal Pharmaceutical Society has criticised the way in which the withdrawal was communicated.
The Medicines and Healthcare products Regulatory Agency announced earlier
this week that the drug should be withdrawn from the market in the next
six to 12 months. The announcement came after national newspapers reported
the planned withdrawal.
No new patients should be prescribed co-proxamol. Patients currently
taking it should consider alternative pain relief at their next routine
medicines review, according to advice from the Committee on Safety of
Medicines.
The MHRA, supported by the CSM, has concluded that the efficacy of the
drug is poorly established and the risk of death from overdose is “unacceptable”.
This week’s decision followed a 12-week public consultation last
year, seeking views on the benefits and risks of the drug. There were
52 respondents and opinion was divided between prescribing advisers and
front line clinicians. “The Royal Colleges and other prescribing
advisers were unanimously in favour of withdrawing co-proxamol, while
current prescribers and patients tended to favour its continued availability,” the
MHRA reports. Sue Kilby, head of practice at the Royal Pharmaceutical
Society, said: “The Society is unable to identify any strong reason
as to why co-proxamol should remain generally available.” She pointed
out that many hospitals had already stopped or restricted use of co-proxamol
and that patients admitted to hospital who were taking the product were
often changed to another analgesic. She warned that this could result
in patients taking two or more paracetamol combination analgesics when
they return home.
Latest figures from the Department of Health reveal that annually co-proxamol
is responsible for up to 400 deaths caused by drug overdose, with a fifth
of deaths being accidental. The statistics make co-proxamol the second
most common cause of fatal drug overdose behind tricyclic antidepressants.
Changes to patient information in 1985, which highlighted the potential
fatal risk in overdose and led to the British National Formulary classifying
the drug as “less suitable for prescribing”, were ineffective
in reducing the death rate, the MHRA said this week.
David Pruce, director of practice and quality improvement at the Society,
called on the MHRA urgently to review how it communicates withdrawals
of medicines and alerts. “Co-proxamol is widely prescribed and
the news of its withdrawal has inevitably led to concern among some patients.
It would have been helpful if the MHRA had communicated direct with health
care professionals before the story appeared in the media.”
Single agents provide more flexibility
Sharron Millen, surgical director of pharmacy
at Southampton General Hospital, welcomed the decision to take
co-proxamol off
the market. “Clinical
evidence suggests that co-proxamol isn’t any better than
paracetamol on its own. Here in Southampton we don’t initiate
it at all because we don’t think it works. It contains a
subtherapeutic dose of paracetamol and if you are on warfarin it
can affect the way your blood clots even more,” she said.
She added that using single agents such as paracetamol and dihydrocodeine
instead of combined preparations like co-proxamol can provide more
benefit. “Using single agents provides more flexibility with
dosing schedules and an opportunity to titrate analgesia demands
to pain more effectively because you can maximise the dose of the
individual agents you use,” she said. |
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