Five unapproved pharmaceutical drugs ID’d in supplements marketed to improve memory, cognition
THURSDAY, Sept. 24, 2020 (HealthDay News) — Supplements marketed to improve memory and cognitive function frequently contain unapproved drugs, often at supratherapeutic dosages, according to a study published online Sept. 23 in Neurology: Clinical Practice.
Pieter A. Cohen, M.D., from Cambridge Health Alliance in Somerville, Massachusetts, and colleagues examined the presence of unapproved pharmaceutical drugs (omberacetam, aniracetam, phenylpiracetam, or oxiracetam) in 10 over-the-counter dietary supplements marketed to improve memory and cognitive function.
The researchers found that omberacetam and aniracetam were identified in the 10 products tested, along with three additional unapproved drugs (phenibut, vinpocetine, and picamilon). Consumers could be exposed to pharmaceutical-level dosages of drugs by consuming recommended serving sizes, including a maximum of 40.6 ± 0.4 mg omberacetam, 502 ± 0.8 mg aniracetam, 15.4 ± 0.3 mg phenibut, 4.3 ± 0.1 mg vinpocetine, and 90.1 ± 0.7 mg picamilon. Several of the drugs detected were not declared on the label, while several that were declared were not detected. Seventy-five percent of declared quantities were inaccurate for the 12 products with drug quantities provided on the label. When using individual products, consumers could be exposed to dosages that are up to fourfold greater than pharmaceutical dosages and as many as four unapproved drugs.
“The presence of these five 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 United States,” the authors write.
One author disclosed financial ties to UpToDate.
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