The Risk of Dementia Associated With The Aluminum Salts Added to Foods and Drugs

One of the earliest major projects of Associated Pharmacologists & Toxicologists (APT) was petitioning the US Food & Drug Administration (FDA) to reevaluate the safety of aluminum salts as components of over-the-counter (OTC) products.

The APT petition to the FDA was submitted in 1981. At that time antacid products, such as Rolaids, were primarily aluminum salts. Detailed concerns about the potential safety risks with loading consumers, especially elderly consumers, with aluminum were described in detail in a 1985 paper (Lione, 1985).

The origins of the concern with the potential toxicity of aluminum had come from the identification of dementias (and blood pathologies) that had developed in dialysis patients who had been dialyzed with tap water that had residual aluminum in it (Alfrey, 1980). The source of that aluminum was the residual water content from the use of aluminum salts in the treatment of tap water. As we get older, it is not uncommon for renal function to decline, so aluminum exposures that would be limited in a younger population might reach toxic levels in the elderly.

The FDA did not act on the petition request, but subsequently, some manufacturers reformulated their products to replace the aluminum salts. For example, Rolaids antacid tablets are now composed entirely of calcium carbonate and magnesium hydroxide (DailyMed, 2023; Wikipedia/Grote, 2022). The buffered aspirin product, The regular strength buffered aspirin,“Bufferin,” also once contained an aluminum salt, now is formulated using magnesium oxide (Wikipedia/Aspirin, 2024).

Based on clinical and pathological analysis of post mortem brain samples, it appears that dementia may have multiple causes. In classic cases of Alzheimer's disease, brain cells contain abnormalities described as plaques and tangles. But in some patients with dementia, brain pathology doesn't include these pathologies. One study reported that 14% of its patient population with dementia did not have any notable brain pathology (Schnieder, 2007). When elevated aluminum has been reported in brain tissue, it can not be established as a cause of brain pathology or the result of brain pathology that permitted aluminum to gain access to neurological tissues. Aluminum doesn't have a useful physiological function (Alfrey 1986), so even with a lack of clear association between aluminum and dementia, the prophylactic reduction of aluminum intake is a reasonable safety precaution, given what we know about the neurotoxicity of aluminum (Lione, 1983).

For more information or your questions about this topic, please contact:

Armand Lione, Ph.D.

armandlione@gmail.com


References:

Lione, A., 1985 Aluminum intake from non-prescription drugs and sucralfate. Gen Pharmacol. 1985;16(3):223-8. doi: 10.1016/0306-3623(85)90073-4. PMID: 3839482.

Alfrey AC, Hegg A, Craswell P. Metabolism and toxicity of aluminum in renal failure. Am J Clin Nutr 1980; 33:1509-1516.

DailyMed, 2024. ROLAIDS EXTRA STRENGTH ANTACID MINT. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0ce3e7ee-aa52-16bc-e063-6294a90a527d

Wikipedia/Irving W. Grote, 2022. https://en.wikipedia.org/wiki/Irvine_W._Grote

Wikipedia/Aspirin, 2024. https://en.wikipedia.org/wiki/Aspirin#Gastrointestinal

Schneider, JA et al: Mixed brain pathologies account for most dementia cases in community-dwelling older persons. Neurology 69 (24) 2197-2204, 2007. https://doi.org/10.1212/01.wnl.0000271090.28148.24

Alfrey A.C. (1986). Aluminum. Trace Elements in Human and Animal Nutrition, Vol 2 (W. Mertz, ed.) Academic Press, Orlando. p. 399.

Lione A. The prophylactic reduction of aluminium intake. Food Chem Toxicol. 1983 Feb;21(1):103-9. doi: 10.1016/0278-6915(83)90277-6. PMID: 6337934.

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