Over-the-counter supplements advertised to improve memory and cognitive function may contain unapproved pharmaceutical drugs in potentially dangerous combinations and dosages, new research shows.
"Americans spend more than $600 million on over-the-counter smart pills every year, but we know very little about what is actually in these products," Pieter A. Cohen, Harvard Medical School, Boston, Massachusetts, told Medscape Medical News.
"Finding new combinations of drugs [that have] never been tested in humans in over-the-counter brain-boosting supplements is alarming," said Cohen.
The study was published online September 23 in Neurology Clinical Practice, a journal of the American Academy of Neurology (AAN).
Buyer Beware
In a search of the National Institutes of Health (NIH) Dietary Supplement Label Database and the Natural Medicines Database, Cohen and colleagues identified 10 supplements labeled as containing omberacetam, aniracetam, phenylpiracetam, or oxiracetam — four analogs of piracetam that are not approved for human use in the US. Piracetam is also not approved in the US.
In these 10 products, five unapproved drugs were discovered — omberacetam and aniracetam along with three others (phenibut, vinpocetine and picamilon).
By consuming the recommended serving size of these products, consumers could be exposed to pharmaceutical-level dosages of drugs including a maximum of 40.6 mg omberacetam (typical pharmacologic dose 10 mg), 502 mg of aniracetam (typical pharmacologic dose 200-750 mg), 15.4 mg of phenibut (typical dose 250-500 mg), 4.3 mg of vinpocetine (typical dose 5-40 mg), and 90.1 mg of picamilon (typical dose 50-200 mg), the study team reports.
Several drugs detected in these "smart" pills were not declared on the label, and several declared drugs were not detected in the products. For those products with drug quantities provided on the labels, three quarters of declared quantities were inaccurate.
Consumers who use these cognitive enhancers could be exposed to amounts of these unapproved drugs that are fourfold greater than pharmaceutical dosages and combinations never tested in humans, the study team says. One product combined three different unapproved drugs and another product contained four different drugs.
"We have previously shown that these products may contain individual foreign drugs, but in our new study we found complex combinations of foreign drugs, up to four different drugs in a single product," Cohen told Medscape Medical News.
The presence of these unapproved drugs in supplements, including at supratherapeutic dosages, suggests "serious risks to consumers and weaknesses in the regulatory framework under which supplements are permitted to be introduced in the US," Cohen and colleagues write.
"We should counsel our patients to avoid over-the-counter 'smart pills' until we can be assured as to the safety and efficacy of these products," said Cohen.
Concerning Findings
Reached for comment, Glen R. Finney, MD, fellow of the American Academy of Neurology, said two findings are very concerning: the lack of listed ingredients and especially the presence of unlisted drugs at active levels.
"What if a person has a sensitivity or allergy to one of the unlisted drugs? This is a safety issue and a consumer issue," Finney told Medscape Medical News.
Despite being widely promoted on television, "over-the-counter supplements are not regulated, so there is no guarantee that they contain what they claim, and there is very little evidence that they help memory and thinking even when they do have the ingredients they claim in the supplement," said Finney, who directs the memory and cognition program, Neuroscience Institute, Geisinger Health System, Wilkes-Barre, Pennsylvania.
"The best way to stay safe and help memory and thinking is to speak with your health providers about proven treatments that have good safety regulation, so you know what you’re getting, and what you’re getting from it," Finney advised.
The study had no targeted funding. Cohen has collaborated in research with NSF International, received compensation from UptoDate, and received research support from Consumers Union and PEW Charitable Trusts. Finney has no relevant disclosures.
Neurol Clin Pract. Published online September 23, 2020. Full text
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