Research links soluble paracetamol with increased risk of CVD

Doctors have warned that people should try to avoid taking dissolving, fizzy paracetamol that contains salt, after a large study uncovered a link with a significantly increased risk of heart attacks, stroke, heart failure and death.
 
The findings stem from a study of nearly 300,000 patients registered with UK GPs, published in the European Heart Journal.
 
As part of the research, more than 4500 patients with high blood pressure who had been prescribed sodium-containing paracetamol were compared with 146,866 patients who had high blood pressure and had been prescribed paracetamol without sodium.
 
The comparison showed the risk of heart attack, stroke or heart failure after one year for patients with high blood pressure taking sodium-containing paracetamol was 5.6%, while it was 4.6% among those taking non-sodium-containing paracetamol.
 
The one-year risk of death was also higher at 7.6% (404 deaths) versus 6.1% (5510 deaths).
 
Meanwhile, there was a similar increased risk among patients without high blood pressure.
 
Among those taking sodium-containing paracetamol, the one-year cardiovascular disease (CVD) risk was 4.4%, compared to 3.7% for those taking non-sodium-containing paracetamol. The risk of dying was 7.3% and 5.9%, respectively.
 
All patients were aged 60–90 years and the researchers followed them up for a year.
 
Professor Chao Zeng from Xiangya Hospital in China led the research, and said his team also found that the risk of cardiovascular disease and death increased as the duration of sodium-containing paracetamol intake increased.
 
‘The risk of cardiovascular disease increased by a quarter for patients with high blood pressure who had one prescription of sodium-containing paracetamol, and it increased by nearly a half for patients who had five or more prescriptions of sodium-containing paracetamol,’ he said.
 
‘We saw similar increases in people without high blood pressure. The risk of death also increased with increasing doses of sodium-containing paracetamol in both patients with and without high blood pressure.’
 
Sodium, one of the main components of salt, is used widely in drug preparations for enhancing solubility and disintegration; in 2018, 170 people per 10,000 of the population in the UK were using sodium-containing medications, with a higher proportion among women.
 
However, effervescent and soluble formulations of 0.5 g tablets of paracetamol also contain high amounts of sodium – 0.44 g and 0.39 g, respectively.
 
Therefore, a person taking the maximum daily dose of two 0.5 g effervescent tablets every six hours would consume up to 3.5 g of sodium – a dose that exceeds the total daily intake of 2 g a day recommended by the World Health Organization.
 
In an editorial to accompany the research paper, The George Institute’s Professor Alta Schutte and Professor Bruce Neal wrote that there were 42 million paracetamol-containing medicines prescribed in the UK alone in 2014, with a further 200 million packs sold over the counter.
 
‘This equates to [roughly] 6300 tons of paracetamol sold each year in the UK, with the figure for France close to 10,000 tons,’ they wrote.
 
‘Fortunately, only a small proportion of paracetamol formulations contain sodium but, with “fast-acting” and “fizzy” medications increasing in popularity, the adverse effects of medication-related sodium intake look set to rise rather than fall.’
 
Paracetamol is also one of the most commonly used over-the-counter analgesics in Australia, and Professor Zeng said clinicians and patients should be aware of the risks associated with tablets containing sodium and avoid unnecessary consumption, especially when the medication is taken for a long period of time.
 
‘Given that the pain relief effect of non-sodium-containing paracetamol is similar to that of sodium-containing paracetamol, clinicians may prescribe non-sodium-containing paracetamol to their patients to minimise the risk of cardiovascular disease and death,’ he said.
 
‘People should pay attention not only to salt intake in their food but also not overlook hidden salt intake from the medication in their cabinet.’
 
Meanwhile, Professors Schutte and Neal have called for urgent action to be taken.
 
The editorial states that the most plausible and effective strategy is likely to be the mandatory labelling of all medications containing significant quantities of sodium with a front-of-pack warning label.
 
‘The weight of the evidence makes ongoing inaction on sodium-containing medications untenable,’ they wrote.
 
‘Particularly concerning is the observation in some surveys that up to 94% of users of fizzy medications are self-medication using over-the-counter preparations.
 
‘There is an immediate need for protection of consumers against these risks.’
 
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