Excess sodium from certain forms of acetaminophen may increase CVD, mortality risk
Excess daily intake of sodium from soluble or effervescent acetaminophen may increase risk for CVD and all-cause death, regardless of baseline hypertension status, according to research published in the European Heart Journal.
“Excessive sodium intake is a major public health concern globally,” Chao Zeng, MD, of the department of orthopedic surgery at Xiangya Hospital of Central South University in Changsha, China, and colleagues wrote. “In addition to dietary sodium intake, sodium-containing drugs are another source of sodium intake as it is widely used in drug preparations for enhancing solubility or disintegration.”
Zeng and colleagues highlighted that acetaminophen 0.5 g, a commonly used pain reliever, in its effervescent or soluble forms contains 0.44 g and 0.39 g of sodium, respectively. The maximum daily dose of acetaminophen 0.5 g is 4 g per day, correlating to 3.5 g of sodium in its effervescent form and 3.1 g in soluble form, exceeding WHO recommended daily limit of 2 g per day.
Therefore, researchers utilized the Health Improvement Network to perform two cohort studies evaluating the effects of sodium-containing (effervescent or soluble formulation) compared with non-sodium-containing acetaminophen (tablet, oral suspension or capsule) on 1-year CVD outcomes and all-cause mortality among individuals with (n = 151,398) and without hypertension (n = 147,299).
Sodium-containing-acetaminophen and CV risk
Researchers observed elevated CVD risk in patients with and without hypertension taking sodium-containing acetaminophen compared with non-sodium acetaminophen (with hypertension, 5.6% vs. 4.6%; HR = 1.59; 95% CI 1.32-1.92; without hypertension, 4.4% vs. 3.7%; HR = 1.45; 95% CI, 1.18-1.79).
Risk for all-cause mortality was also higher among those who took sodium-containing acetaminophen compared with those who took non-sodium-containing acetaminophen, regardless of hypertension status (7.6% vs. 6.1%; HR = 2.05; 95% CI, 1.92-2.19).
Zeng and colleagues observed a dose-response relationship between the number of daily sodium-containing acetaminophen prescriptions and odds of CVD in patients with hypertension (OR for 1 = 1.26; OR for 2-4 = 1.33; OR for 5 = 1.45; P for trend = .034).
A similar dose-dependent trend was observed for all-cause mortality risk (OR for 1 = 2.77; OR for 2-4 = 3.02; OR for 5 = 3.64; P for trend = .001) among individuals with hypertension.
The dose-response relationship for CVD and all-cause mortality was similar for patients without hypertension.
Researchers also observed greater risk for incident hypertension among participants taking sodium-containing acetaminophen compared with non-sodium-containing acetaminophen (4.4% vs. 3.6%; HR = 1.37; 95% CI, 1.22-1.54).
“Given that the pain relief of non-sodium-containing acetaminophen is similar to that of sodium-containing acetaminophen, our results suggest revisiting the safety profile of effervescent and soluble acetaminophen use,” the researchers wrote. “Large observational studies mimicking a randomized controlled trial, such as the present study, can provide real-world empirical evidence for public health and clinical care in the absence of clinical trials.”
‘Millions’ increasing their CV risk
In a related editorial, Aletta E. Schutte, PhD, professor and principal theme lead of cardiac, vascular and metabolic medicine in the faculty of medicine and health at the University of New South Wales in Sydney, Australia, and Bruce Neal, MB, ChB, PhD, professor of medicine and executive director at The George Institute for Global Health Australia, discussed the implications of excess sodium intake due to acetaminophen what might be done to mitigate CV risk.
“The direct message from this study is clear — there are likely to be millions of people worldwide taking paracetamol on a daily basis in a ‘fast-acting’ effervescent or soluble formulation who are increasing their risks of cardiovascular disease and premature death,” Schutte and Neal wrote.
“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 authors wrote. “Information programs that raise public and practitioner awareness of the hidden sodium in medications, and educate about the need to avoid effervescent, dispersible and soluble medicines in all but essential circumstance should also be considered.”
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