Recalls and Warnings

Cognitive Enhancement Supplements Contain Unapproved Drug

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(Date Posted: 11/26/2019)

Several supplements sold in the U.S. and promoted for cognitive enhancement contain significant amounts of the drug piracetam -- a drug that is not approved for use in the U.S. -- according to a study published this week in JAMA Internal Medicine

Piracetam is prescribed in some European countries for cognitive impairment and dementia, but evidence for its efficacy as a cognitive enhancer, or "nootropic," is mixed (Flicker, Cochrane Database Syst Rev 2001; Winblad, CNS Drug Rev 2005). At typical dosages prescribed in Europe (800 mg to 1,200 mg per pill and 2,400 mg to 4,800 mg per day) piracetam can cause adverse effects such as anxiety, agitation, drowsiness, insomnia, and depression. Dosage must also be adjusted based on kidney function. In the U.S., the drug has no FDA-approved use and is not permitted to be sold as a dietary supplement.

However, researchers were able to purchase five products sold online in the U.S. that were labeled as dietary supplements and listed amounts of piracetam in doses ranging from 250 mg to 800 mg per capsule: Relentless Improvement, Nootropics, BPS, Cognitive Nutrition, and Specialty Pharmacy. Two samples of each product were tested. Analyses showed that Specialty Pharmacy was labeled as containing 700 mg of piracetam per serving but contained no detectable amount of the drug. Samples of the four other products were found to contain 85% to 118% of the labeled amount of piracetam, with amounts ranging from 277 mg to 940 mg piracetam per capsule. Recommended daily doses for some of the products exceeded daily dosages prescribed in other countries. Cognitive Nutrition's NeuroPill, for example, contained 11,283 mg piracetam per day if taken in the highest recommended dose of 12 capsules -- more than twice the daily dosage for piracetam when prescribed in Europe.

(Be aware that some nootropic supplements, such as Noopept, may contain compounds that are chemically very similar to piracetam).

Also see ConsumerLab's answer to the question: Do any supplements really help with brain function, like memory and cognition?

See related warnings:

Supplements Promoted for Alzheimer's Disease and Dementia Sell "False Hope," Warns FDA

Prescription and Street Drug Alternatives Found in Male Enhancement, Mood, and Sleep Supplements

For more information, use the link below.

Presence of Piracetam in Cognitive Enhancement Dietary Supplements



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For information about reporting serious reactions and problems with medical products to the U.S. Food and Drug Administration through its MedWatch reporting program, please go to http://www.fda.gov/medwatch/how.htm.


 

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