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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:

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Categories: Cognitive Neuroscience, Education & Lifelong Learning

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As seen in The New York Times, The Wall Street Journal, BBC News, CNN, Reuters,  SharpBrains is an independent market research firm tracking how brain science can improve our health and our lives.

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