The Cambridge Health Alliance–led study notes in a research letter published in JAMA that galantamine is approved as a prescription medication by the FDA for the treatment of mild-to-moderate Alzheimer’s dementia. “However, galantamine is ineffective in treating mild cognitive impairment or preventing Alzheimer dementia, but, when sold as a dietary supplement, the drug is marketed for a variety of cognitive conditions including memory enhancement,” the authors noted.
Past studies have suggested mislabeling of both generic drugs and dietary supplements, according to the study team, which explained, “While the regulatory framework for prescription drugs and dietary supplements are distinct in the U.S., labels in both categories are required to accurately represent the products’ contents. To our knowledge, whether label accuracy differs between generic drugs and dietary supplements containing the same active pharmaceutical ingredient has not been studied.”
The investigation had two components:
• The accuracy of galantamine products formulated both as generic drugs and dietary supplements, and
• Quantification of microorganisms in the products because contamination can occur when products are manufactured without following appropriate control measures.
In June 2023, the researchers purchased all dietary supplements available for sale in the U.S. on Amazon.com labeled with both galantamine as an ingredient and a Supplement Facts panel. A Supplement Facts panel was required to ensure that the product was marketed as a dietary supplement. That September, all generic immediate-release formulations of galantamine available in the U.S. were purchased.
The researchers reconstituted the content of the products in water, then analyzed them for the presence of galantamine employing ultrahigh-performance liquid chromatography and mass spectrometry and quantified using liquid chromatography diode array detection. Membrane filtration was used to determine contamination with microorganisms; retrieved microorganisms were quantified and identified by matrix-assisted laser desorption ionization, time of flight mass spectrometry, and whole-genome sequencing.
Overall, 10 brands of galantamine supplements and 11 brands of generic galantamine medications were included. Generic drugs were labeled as containing 4 mg, 8 mg, and 12 mg of galantamine per tablet or capsule, and the actual content of galantamine in the generic drugs ranged from 97.5% to 104.2% of the labeled content. No generic drugs were contaminated with microorganisms.
Dietary supplements were labeled as containing 4 mg, 6 mg, 8 mg, and 12 mg of galantamine per serving. The actual quantity of galantamine in the dietary supplements ranged from less than 2% to 110% of the labeled quantity, according to the research letter.
In addition, three supplements (30%) were contaminated with Bacillus cereus sensu stricto–encoding enterotoxin genes associated with diarrheal illness. “The contaminated supplements contained 60%, 62%, and 75% of the labeled quantity of galantamine. All 11 generic drugs (100%) and one supplement (10%) contained a quantity of galantamine that was within 10% of the quantity declared on the label,” the researchers advised.
“Galantamine sold as generic drugs was accurately labeled and free of contamination, in contrast to galantamine sold as dietary supplements,” the study team concluded. “The detected quantities of B cereus ss may suggest lack of appropriate quality control during manufacturing. However, adverse health effects would not be expected with these quantities of bacteria.
For patients with Alzheimer disease, use of galantamine supplements instead of generic galantamine may adversely affect their care. Furthermore, the sale of inaccurately labeled galantamine supplements promoted for nonspecific memory and other cognitive problems is concerning given the lack of proven efficacy, potential drug-drug interactions, and adverse effects, including nausea, vomiting, dizziness, bradycardia, and syncope.”
Limitations of the study include that the products were purchased at only one time point. It is not known whether the results are generalizable to other supplement ingredients, such as niacin, potassium, and iron, which are also available as either dietary supplements or generic drugs.
“The laws regulating dietary supplements should be reformed such that the FDA has enforcement mechanisms to ensure that dietary supplement labels accurately reflect their contents,” the authors pointed out. “Meanwhile, clinicians should query patients with memory concerns about the use of dietary supplements and advise patients not to use galantamine supplements.”
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