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Prescribing Advice for GPs

An NHS Prescribing Advisers' Blog

Coxibs for patients on low dose aspirin?

The Lancet has published a review article that aims to assess whether patients who are at risk of cardiovascular events and are taking low dose aspirin as prophylaxis would be better taking a standard non-steroidal anti-inflammatory (NSAID) or a COX-II selective non-steroidal anti-inflammatory (Coxib).

The summary of the article admits that arriving at conclusions in this area is difficult because:

  • Trials have not answered directly whether low-dose aspirin is cardioprotective when combined with coxibs
  • Comparing cardiovascular and gastrointestinal risks is difficult
  • The likelihood and severity of cardiovascular events differ between individuals
  • The cardiovascular risk posed by all NSAIDs varies by agent and exposure
  • Mortality associated with gastrointestinal events is less frequent

Despite all of this the article concludes that, "data support the conclusion that COX-2 inhibitors are preferable to non-selective NSAIDs in patients with chronic pain and cardiovascular risk needing low-dose aspirin". However, it is also stated that risks and benefits need to be assessed individually.

The article does not appear to assess the place of using a standard NSAID with a gastroprotective agent such as a proton pump inhibitor unlike the recent MeReC Extra that covered the same topic.

Action: This recent article adds nothing new to the NSAID debate. Clinicians would be better served reading the MeReC Extra when looking for a balanced assessment of the risks and benefits of NSAID and coxibs.

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Paediatric Cough Medicines - No help, some harm!

The New England Journal of Medicine has published an article that gives an insight into recent concerns raised in the United States of America over the risk-benefit profile of children's cough and cold medications.

The products discussed are widely available direct to the public and contain antihistamines, decongestants, antitussives, and expectorants for the relief of coughs and colds. Despite the huge range of products and sales of 95 million packs each year there is little evidence to support continued use. All six randomised placebo controlled trials conducted since 1985 have failed to show any meaningful difference between active ingredients and placebo.

There is however evidence of harm with some 750,000 calls made to poison centres since January 2000 and 1,500 visits to emergency rooms by children under two who had taken these products between 2004 and 2005. Finally, over the past few decades, the Food and Drug Administration (FDA) have identified 123 deaths related to the use of such products in children under six.

The article goes on to criticise the marketing and continued availability of these products and the lack of action taken by the FDA in light of the facts laid out above.

Action: The harms associated with cough and cold medications for children appear to outweigh any potential benefits. Clinicians should avoid recommended or supporting the use of these products. Pharmacies should also avoid recommending these products and may even consider removing them from sale.

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MHRA clarifies co-proxamol position

The Medicines and Healthcare products Regulatory Agency (MHRA) has clarified what is expected to happen following the cancellation of marketing authorisations (MAs) for co-proxamol at the end of 2007.

The MHRA announced in January 2005 that co-proxamol would be withdrawn at the end of 2007 following a phased withdrawal. This decision was reached after a safety review of the risks and benefits of co-proxamol concluded that the "efficacy of co-proxamol is poorly established and the risk of toxicity in overdose, both accidental and deliberate, is unacceptable".

The following action points have been recommended:

  • No further stock released into the supply chain after 31st December 2007
  • Existing stock already in the supply chain can be supplied until the product expiry date
  • Manufacturers to accept returned surplus stock from the supply chain
  • For a very small number of patients unlicensed co-proxamol can be supplied, on the responsibility of the prescriber

It is also likely that the price of co-proxamol will increase following the withdrawal of the marketing authorisation.

Action: Clinicians should ensure that audits have been undertaken to change co-proxamol prescriptions to more suitable and licensed alternatives. Where alternatives have been fully explored and have proven unsuitable, unlicensed co-proxamol may be an option.

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Varenicline safety update

The Medicines and Healthcare products Regulatory Agency has announced an update to the product information for varenicline (Champix®) highlighting concerns over suicidal thoughts and behaviour.

Following a European review in conjunction with the European Medicines Agency (EMEA) it has been recommended that:

  • Clinicians should already be aware of the risk of using varenicline in patients who have an underlying mental illness
  • Clinicians should advise patients who are trying to stop smoking that they can develop symptoms of depression
  • Patients who develop suicidal thoughts while taking varenicline should stop their treatment and contact their doctor immediately

Action: Clinicians should avoid using varenicline in patients with underlying mental illness. Patients who are prescribed varenicline should be advised as recommended above.

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December NICE Guidance

The National Institute of Health and Clinical Excellence has published new guidance for the month of December.

Included in this month's guidance is a Clinical Guideline covering Atopic Eczema in Children. It covers the management of eczema in children from birth to 12 years old including diagnosis, treatment and education for the child and their parents or carers.

The Quick Reference Guide contains useful information of assessing the severity of eczema and taking a stepped approach to treatment with emollients recommend as the basis for treatment.

Action: Clinicians who diagnose and treat children with atopic eczema will find this Clinical Guideline is a useful aid to management of this condition.

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