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.
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.
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.
