The new study was written by Cohen and his frequent collaborators, Bharathi Avula, PhD and Ikhlas Khan, PhD, both of the National Center for Natural Products Research within the School of Pharmacy at the University of Mississippi. The research was published in the journal Clinical Toxicology.
Dr Cohen, who is associated with Harvard Medical School, has been the lead author on a string of studies that have documented unapproved drugs and other dodgy ingredients in supplements that are widely for sale.
Drug used in many countries
The subject of his latest research is the drug centrophenoxine, also known as meclofenoxate. From a chemical description standpoint, this substance is an ester of dimethylethanolamine (DMAE) and 4-chlorophenoxyacetic acid (pCPA). According to one reference, the drug was originally developed in France in 1959. According to another reference, it is available as a drug under the brand name Lucidril in Egypt and Japan.
According to the present study, the drug is used in China and other, unspecified countries to treat ethanol toxicity, brain trauma, dementia and other indications.
The researchers noted the drug has been shown to affect choline and other neurotransmitter levels in rat brains. But clinical evidence for effects in humans is scanty at best. It has not been approved by FDA for any indication.
Unpredictable levels found in supplements
To test how this substance is being marketed as a dietary supplement in the United States the team found seven products for sale online and bought samples of each for analysis. They also obtained a verified sample of centrophenoxine to use in setting up baseline calibration for their product analysis.
The products were sold with a variety of claims including “supports memory and cognition,” “neuroprotection,” and “mental acuity, healthy aging.”
The analysis revealed that centrophenoxine, which was listed on all of the labels, was present in the products at dosages ranging from 238 mg/day to more than 700 mg/day by the recommended maximum intake on the labels. Only one product came close to meeting label claim, with 95% of the stated label amount found in the actual product. Others hit only 26% of label claim as a low up to about 88%.
Those maximum intake levels compare to the dosages the pharmaceutical is offered in, which is commonly sold in 250 mg or 500 mg tablets, the authors said.
“Our study adds centrophenoxine, a drug that may increase choline levels in the central nervous system, to several other prohibited drugs, including picamilon, phenibut, piracetam, omberacetam, tianeptine, and aniracetam, found in cognitive enhancement supplements sold in the US. The FDA should warn consumers and manufacturers that centrophenoxine is an unapproved drug, and clinicians should advise patients that cognitive enhancement supplements may contain any one of a number of unapproved and prohibited drugs,” they concluded.
Source: Clinical Toxicology
doi.org/10.1080/15563650.2022.2109485
The unapproved drug centrophenoxine (meclofenoxate) in cognitive enhancement dietary supplements
Authors: Cohen PA, Avula B, Khan I
