Research Discovers Multiple Unapproved Drugs With “Brain Boosting” Supplements

Supplements claiming to improve mental concentration and memory include unapproved medications and potentially dangerous combinations and doses, according to a new study published online on September 23, 2020. May be Neurology clinical practice, The official journal of the American Academy of Neurology. Researchers have found five such drugs that have not been approved in the United States among the supplements they examined. Supplements are sometimes referred to as “nootropics,” “smart drugs,” or “cognitive enhancers.”

Dr. Pieter A. Cohen, MD, a research author at Harvard Medical School in Boston, Massachusetts, said: Of these supplements, they pose a potentially serious health risk. Unapproved drug Some unlabeled drugs were also detected in these products, and the dose of the unapproved drug was found to be four times higher than what would be considered the normal dose. “

According to Cohen, supplements can be especially risky when used in combination with prescription medications or instead of seeking medical advice.

Unlike Pharmaceuticals The law does not require US Food and Drug Administration (FDA) approval if they must be proven safe and effective for their intended use before being sold to consumers. Diet supplements For safety or effectiveness before they reach the consumer. The FDA will take action after a product is on the market if the product is labeled incorrectly or contains an unapproved product.

For this study, researchers searched the National Institutes of Health’s dietary supplement label database and natural medicine database to list drugs similar to piracetam that were previously included in supplements but not approved in the United States. I searched for cognitive supplements that have similar chemical structures but slightly different drugs. Analog may be introduced in supplements to circumvent the law.

Researchers have identified 10 supplements. 8 promised to enhance mental function, 1 was sold as a “workout explosive”, and the other contained the words “sustain, endure, overcome” on the label.

Researchers examined each content Supplement A measurement of each drug present, using a variety of methods.

In the 10 supplements they examined, researchers detected five unapproved drugs. The two were analogs of piracetam called omberasetam and aniracetam. Others were the unapproved drugs vinpocetine, phenibut and picamilon. The FDA has warned that vinpocetine should not be taken by women of childbearing age. Not all of the risks of these drugs are known, but side effects include increased and decreased blood pressure, agitation, sedation, and hospitalization.

All 10 supplements contained onveracetam, which is prescribed in Russia for traumatic brain injury and mood disorders. A typical drug dose is 10 milligrams (mg). The recommended supplement size dose was as high as 40 mg, four times the drug dose.

Some supplements contained multiple unapproved drugs. One product contained four unapproved drugs.

“People who use these cognitive-enhancing supplements may be at potential serious health risk because each product has as many as four unapproved drugs and has never been tested in humans in combination. There is sex, “says Cohen. “The effects of taking unverified combinations of unapproved drugs at unpredictable doses are unknown and should be warned to anyone taking these supplements.”

Researchers also medicine Most of the quantities listed on the label and declared were inaccurate.

“The fact that these supplements are listed in the official database does not mean that the labeling is accurate or that the dosage levels of the ingredients in these supplements are safe,” Cohen said. .. “U.S. law does not allow the introduction of non-approved medicines into dietary supplements, but the FDA is responsible for eliminating those products. The FDA is responsible for eliminating non-approved medicines. We have issued a series of warnings to companies that sell supplements that contain, but such medications remain openly listed in the database as an ingredient in supplements. There are also concerns about the quality and legality of the supplements we have. “

One of the limitations of this study is that it has not examined all unapproved drugs sold in cognitive supplements.