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Changing international guidance on sodium-containing medications to improve cardiovascular health
Excess sodium intake, primarily through dietary salt, is a well-known risk factor for high blood pressure (also known as hypertension), cardiovascular disease, and stroke.
22 October 2024
The NHS recommends a maximum daily salt intake of 6g (equivalent to 2.4g or 104mmol of sodium) for adults, with even stricter advice for those with conditions like hypertension. However, research led by Professor Li Wei and collaborators at the University of Dundee highlighted that certain types of medicines are significant source of sodium.
Specifically, effervescent, dispersible, and soluble medicines, which are often used for rapid dispersion in water, can contain high levels of sodium. For instance, a single dispersible paracetamol tablet may contain 18.6 mmol of sodium, potentially contributing significantly to a patient's daily sodium intake, especially when taken regularly.
In 2013, while sodium content and labelling were regulated for foods, there were no such requirements for medications. Professor Wei and colleagues hypothesized that these sodium-rich medications could contribute to cardiovascular disease, particularly through long-term use. The research, published in the British Medical Journal, was pioneering to highlight the significant health risks posed by high sodium content in medications, marking the first time the long-term risks of such medicines had been demonstrated.
The findings were led to a broader awareness and changes in health guidelines and regulations and subsequently influenced the Director of Vigilance and Risk Management of Medicines at the Medicines and Healthcare Products Regulatory Agency (MHRA) to communicate these findings to the European Medicines Agency (EMA). This led to the issuance of European-wide guidelines on re-labelling medicines to include sodium content information.
The EMA's new guidance, published in 2015, mandated that any medicine with sodium content exceeding 1mmol (23mg) per dose must be labelled with the sodium content in mg per dose and as a percentage of the recommended daily intake. These guidelines applied not only to new medications but also required existing medicines to be relabelled within 12 months. The research has had a tangible impact on public health practices. The NHS incorporated advice on the sodium content of effervescent medical supplements and painkillers into their broader dietary guidelines, advising patients to consider switching to non-effervescent alternatives if they need to reduce their salt intake.
A follow-up study using data from The Health Improvement Network (THIN) database, which includes about 6% of the UK population, showed a significant decrease in the prescription of high sodium-containing medications following the publication of the research in BMJ. The prescription rates dropped from 1029.33 per 10,000 inhabitants before the publication to 841.33 per 10,000 after, indicating a 4.5-fold increase in the annual rate of decrease in such prescriptions. This reduction in high sodium medication prescriptions is a clear indication of the research's positive impact on patient health and prescribing practices.