Study: Some “brain-boosting” supplements sold in the US contain not-approved drugs at supratherapeutic doses, exposing users to unknown side effects

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Some brain-boost­ing sup­ple­ments con­tain an unap­proved drug that could harm users, study warns (STAT news):

“Promis­ing to lift brain fog or improve mem­o­ry, brain-boost­ing sup­ple­ments have joined sex­u­al-enhance­ment and weight-loss reme­dies in the light­ly reg­u­lat­ed world of dietary sup­ple­ments. These prod­ucts may be sold legal­ly with broad-brush come-ons like these, as long as they don’t make spe­cif­ic claims about treat­ing a dis­ease — or con­tain actu­al drugs.

New research led by Dr. Pieter Cohen of Har­vard Med­ical School doc­u­ments five sup­ple­ment brands for sale in the U.S. that con­tain var­i­ous amounts of pirac­etam, a drug pre­scribed in Euro­pean coun­tries for cog­ni­tive impair­ment in demen­tia but not approved in the U.S … Relent­less Improve­ment, Nootrop­ics, and Spe­cial­ty Phar­ma­cy sold their prod­ucts as pirac­etam. BPS named its sup­ple­ment Com­pel, and Cog­ni­tive Nutri­tion called its Neu­roPill but includ­ed pirac­etam on the label.

Side effects of pirac­etam include agi­ta­tion, anx­i­ety, and depres­sion, but that’s when pre­scribed at a stan­dard dose of the drug, whose mech­a­nism of action was described in one research paper as “an enig­ma.” In Europe, old­er patients tend to be pre­scribed low­er dos­es, Cohen said, to account for reduced kid­ney func­tion that comes with age.”

The Study:

Pres­ence of Pirac­etam in Cog­ni­tive Enhance­ment Dietary Sup­ple­ments (JAMA Inter­nal Medicine).

From the Dis­cus­sion: Con­sumers of cog­ni­tive enhance­ment sup­ple­ments may be exposed to high dosages of a pro­hib­it­ed drug. In Europe, pre­scrip­tion pirac­etam is com­mon­ly for­mu­lat­ed in 800- and 1200-mg tablets with a usu­al dai­ly dose for cog­ni­tive dis­or­ders of 2400 to 4800 mg, with dos­ing adjust­ed based on renal func­tion. In this study, we found sup­ple­ments with indi­vid­ual dos­es of pirac­etam exceed­ing 1500 mg, and dai­ly dos­es greater than 11000 mg. Adverse effects of pirac­etam at phar­ma­ceu­ti­cal dosages include anx­i­ety, insom­nia, agi­ta­tion, depres­sion, drowsi­ness, and weight gain. The risks of pirac­etam in over-the-counter sup­ple­ments at suprather­a­peu­tic dosages, par­tic­u­lar­ly in elder­ly con­sumers with renal insuf­fi­cien­cy, are unknown … Our find­ings demon­strate that even after the FDA reject­ed an appli­ca­tion to mar­ket pirac­etam as a new sup­ple­ment ingre­di­ent, the drug was nev­er­the­less intro­duced into the mar­ket­place. Despite FDA warn­ing let­ters, the prod­ucts remain on the mar­ket. Until the law gov­ern­ing sup­ple­ments is reformed such that prod­ucts adul­ter­at­ed with drugs can be effec­tive­ly removed from the mar­ket, clin­i­cians should advise patients that sup­ple­ments mar­ket­ed as cog­ni­tive enhancers may con­tain pro­hib­it­ed drugs at suprather­a­peu­tic doses.

The Study in Context:

• AARP: A major­i­ty of Amer­i­cans believe dietary sup­ple­ments improve brain health, despite the lack of evidence
• The FDA cracks down on dozens of sup­ple­ments claim­ing to pre­vent or cure Alzheimer’s Disease
• Solv­ing the Brain Fit­ness Puz­zle Is the Key to Self-Empow­ered Aging