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OTC memory supplements may contain risky, unapproved prescriptions

| Oct 13, 2020 | Pharmaceutical Liability

When you take an over-the-counter supplement, you assume it’s safe of it wouldn’t be allowed on the market. Unfortunately, some supplements are made using pharmaceutical drugs that are approved in other countries but not the U.S. Moreover, they are often present in much higher doses than they would be prescribed even if they were approved.

A recent study in the journal Neurology Clinical Practice found that memory and cognitive supplements, called nootropics, were vulnerable to this practice. The researchers analyzed 10 supplements that claimed to enhance memory, sharpen your mental focus and the like. These supplements were all purchased online.

Each supplement openly listed the substances that are considered prescription drugs abroad. However, three-quarters of the supplements inaccurately listed the quantities of the drugs on their labels.

“I have gotten used to the fact that foreign drugs are being sold directly to consumers as supplements,” commented a Harvard University Medical school professor who was involved in the study. “But I was surprised by how many different drugs are being sold in these products.”

The number of different drugs included in the supplements only adds to the risk. That is because combining different medications can cause drug interaction issues. And, some of the combinations the researchers found have never been studied for safety or effectiveness.

“We’re basically completely flying blind when trying to understand what the cocktails of these unapproved drugs would do if you consumed them,” said the Harvard Medical School professor.

Interest in brain-boosting supplements is on the rise

The nootropic industry is booming, according to Consumer Reports. Between 2006 and 2015, sales of OTC memory-boosting supplements have nearly doubled by value. Purchases of these supplements are growing faster than the overall supplement market, according to the Government Accountability Office.

Researchers find piracetam and analogs in the supplements

The researchers combed through two scientific databases to identify substances that are chemically similar to the drug piracetam, which has previously been found in other brain-enhancing supplements. Piracetam is not approved by the FDA, but several countries in Europe, Asia and Latin America have approved the drug to treat dementia, brain injuries, strokes and certain other neurological issues.

They found piracetam and piracetam-like chemicals in all of the supplements, which was no surprise as their labels included the drug. However, some of the supplements they tested contained two to four times the amount of piracetam that would typically be prescribed in countries where it is approved.

In addition, the researchers found two other unapproved drugs, picamilon and phenibut, in the supplements. It is illegal to sell picamilon and phenibut, or any unapproved pharmaceutical drug, as a supplement in the U.S.

Furthermore, the amount of the chemicals listed on the label was often inaccurate.

The combination of high doses of piracetam, inaccurate dose labeling and the combination with other untested drugs increases the risk of serious side effects and interactions. The risk is much higher when using these supplements than it would be if a doctor prescribed the compounds.

The risk of side effects is significant

The CDC recently said that phenibut, one of the unapproved drugs often found in cognitive-enhancing supplements, has been linked to a sharp rise in poison control center calls between 2009 and 2019. Of those cases reported, one in eight involved side effects that were either life-threatening or resulted in significant disability.

In a statement, supplement industry representatives claimed that the study was not representative of the market in general, or the brain and memory supplement market specifically.

Unfortunately, it was only too easy to buy supplements that contained these unapproved drugs.


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