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09.23.20

Supplements Claimed to Improve Concentration May Contain Unapproved Drugs

  • KEYWORDS:
  • Cognitive therapy
  • Concentration
  • FDA Approvals
  • FDA Unapproved
  • TBI

Certain supplements with claims to improve concentration and memory may contain drugs not approved by the Food and Drug Administration (FDA) in potentially dangerous combinations and doses, according to a new study published in Neurology Clinical Practice.

Researchers investigated the National Institutes of Health Dietary Supplement Label Database and the Natural Medicines Database for supplements that listed drugs similar to piracetam. The researchers were looking for analogs of piracetam, drugs with a similar but slightly different chemical structure.

In the study, researchers identified 10 supplements: 8 promised to enhance mental function; 1 that was marketed as “workout explosives”; and 1 that had “outlast, endure, and overcome” on the label. The researchers examined each supplement and measured quantities of each drug present.

In the supplements, there were 5 unapproved drugs, 2 were analogs of piracetam called omberacetam and aniracetam. The other 3 were vinpocetine, phenibut, and picamilon.

All 10 supplements contained omberacetam, which is prescribed in Russia for traumatic brain injury (TBI) and mood disorders. A typical dose of this drug is 10 mg; the doses in a recommended supplement were as high as 40 mg.

Some supplements contained as many as 4 unapproved drugs. Researchers also found that for products with drug quantities provided on the labels, most of the declared quantities were inaccurate.

“Over-the-counter cognitive supplements are popular because they promise a sharper mind, but they are not as closely regulated as pharmaceutical drugs,” said Pieter A. Cohen, MD, Harvard Medical School. “Not only did we detect 5 unapproved drugs in these products, we also detected several drugs that were not mentioned on the labels, and we found doses of unapproved drugs that were as much as 4 times higher than what would be considered a typical dose. With as many as 4 unapproved drugs in individual products, and in combinations never tested in humans, people who use these cognitive enhancement supplements could be exposing themselves to potentially serious health risks.”

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