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This type of painkiller increases the risk of heart attacks, stroke and death, according to experts

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Following the findings of a big study that demonstrates a link with a greatly higher risk of heart attacks, stroke, heart failure, and death, doctors have recommended that people should avoid using dissolving, fizzy paracetamol that contains salt.

The study, which included over 300,000 individuals registered with UK general practitioners (GPs), was published today in the European Heart Journal.

Sodium, one of the main components of salt, is frequently used to enhance the dissolution and disintegration of medications such as paracetamol (also known as acetaminophen) in water. Effervescent and soluble formulations of 0.5 g paracetamol tablets, on the other hand, may include 0.44 and 0.39 g sodium, respectively. A person who takes the maximum daily dose of two 0.5 g tablets every six hours would ingest 3.5 and 3.1 g of sodium, respectively, exceeding the World Health Organization’s recommended total daily intake of 2 g. Other formulas contain a negligible quantity of salt or none at all.

Too much salt in the diet is a major public health concern, as it is linked to an increased risk of cardiovascular disease (CVD) and death in people with high blood pressure. However, there is inconclusive evidence of a similar risk among those with normal blood pressure, and conducting a randomized controlled trial to investigate this would be unethical.

Scientists led by Prof. Chao Zeng of Xiangya Hospital, Central South University in Changsha, China, examined data from the UK’s Health Improvement Network, which is an electronic medical database of GP information for almost 17 million people. They compared 4,532 high blood pressure patients who had been prescribed sodium-containing paracetamol to 146,866 high blood pressure patients who had been prescribed paracetamol without sodium. They also compared 5,351 non-hypertensive patients who were prescribed sodium-containing paracetamol to 141,948 non-hypertensive patients who were prescribed non-sodium-containing paracetamol. The patients were between 60 and 90, and the researchers observed them for one year.

The researchers discovered that patients with high blood pressure who took sodium-containing paracetamol had a 5.6 percent (122 instances of CVD) risk of heart attack, stroke, or heart failure after one year, compared to 4.6 percent (3051 CVD cases) for those who took non-sodium-containing paracetamol. The risk of mortality was also higher: 7.6 percent (404 deaths) and 6.1 percent (5,510 deaths) over one year, respectively.

Patients without high blood pressure faced a comparable higher risk. The one-year CVD risk was 4.4 percent (105 instances of CVD) among those taking sodium-containing paracetamol and 3.7 percent (2079 cases of CVD) among those taking non-sodium-containing paracetamol. There was a 7.3 percent (517 fatalities) and a 5.9 percent (5,190 deaths) chance of dying, respectively.

Prof. Zeng says: “We 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. 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.”

According to Prof. Zeng, clinicians and patients should be aware of the risks associated with sodium-containing paracetamol and avoid unnecessary use, particularly when the medication is used for a long time.

“Although the US Food and Drug Administration requires that all over-the-counter medications should label the sodium content, no warning has been issued about the potentially detrimental effect of sodium-containing paracetamol on the risks of hypertension, cardiovascular disease and death. Our results suggest re-visiting the safety profile of effervescent and soluble paracetamol,” concludes the author.

Source: 10.1093/eurheartj/ehac059

Image Credit: Getty

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