Researchers find dangerous, FDA-rejected drug in supplements—by reading labels

Several supposed brain-enhancing supplements sold in the US contain a questionable drug that has been rejected by the Food and Drug Administration, according to a new analysis published in the journal JAMA Internal Medicine.

Researchers led by Harvard’s Pieter Cohen identified four dietary supplement makers illegally selling the drug, piracetam, in their products.

The researchers were clued in to the presence of the unapproved drug by simply reading the products’ labels. Two of the supplement makers brazenly called their brain pills “piracetam” outright.

In a twist, researchers found that a fifth supplement maker named its product after the unapproved drug but didn’t actually include any piracetam in the product.

Those familiar with the supplement industry may not be surprised by the flagrant products. The sprawling industry now worth over $40 billion is riddled with questionable and unsubstantiated health claims, as well as illicit and potentially dangerous ingredients. Cognition-enhancing supplements, aka nootropics—which logged sales upward of $640 million in 2015 alone—are no different.

In fact, earlier this year, the FDA cracked down on 17 supplement makers who illegally claimed their nootropic supplements could treat Alzheimer’s disease. The agency has specifically called out supplement makers for selling piracetam.

Not so smart

Piracetam is a small-molecule drug that some have claimed can improve memory and other intellectual functions. In some European countries, doctors prescribe it for involuntary muscle jerks, cognitive impairment, dementia, and other conditions. But a 2004 Cochrane Review that examined 24 studies involving 11,959 study participants found no benefits of piracetam over placebo. “Published evidence does not support the use of piracetam in the treatment of people with dementia or cognitive impairment,” the authors concluded.

Moreover, piracetam has significant side-effects, including insomnia, anxiety, agitation, depression, drowsiness, and weight gain.

The FDA rejected an application to market piracetam as a supplement in the US in 2004. The agency has not approved it for any medical use, either.

Nevertheless, piracetam blatantly made its way onto the US market. Cohen and his colleagues found products by a simple Google search for piracetam and ordered samples of five products said to contain the drug.

Of the four that actually did contain piracetam, one had dangerously high levels. In Europe, piracetam is given at a daily dose of 2,400mg to 4,800mg. The Neuropill, sold by the manufacturer Cognitive Nutrition, offered a daily dose of 11,283mg of piracetam. The researchers said this level could be harmful, particularly to elderly patients who have problems with their kidneys.

The researchers call for the FDA and lawmakers to do more to address the problem. They conclude, “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.”

, 2019.  DOI:10.1001/jamainternmed.2019.5507  (About DOIs).

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