In early June, the FDA warned that supplements containing vinpocetine could cause spontaneous miscarriage and issues with fetal development and should be avoided by pregnant women and those of childbearing age. The ingredient may also be listed as vinca minor extract, lesser periwinkle extract, or common periwinkle extract.
A conversation with women purchasing the supplement may alert them to the potential risk, particularly because female customers might be obtaining the supplement to overcome baby brain, the forgetfulness often associated with early pregnancy.
A synthetic compound derived from the alkaloid vincamine, a substance that occurs in the plant vinca minor or periwinkle, vinpocetine is frequently combined with gingko biloba in formulations that claim to improve sports performance, enhance memory and focus, boost energy, and increase weight loss. Controlled trials have not produced evidence supporting any of these claims.
The FDA warning cited a recent study by the National Institute of Health’s National Toxicology Program that found vinpocetine decreased fetal weight and increased the chance of miscarriage in pregnant animals in doses equivalent to a single dose of vinpocetine in humans.
In addition to the fetal risk, vinpocetine can cause hypotension and may increase the rate of bleeding or slow the rate of clotting in patients with bleeding disorders and those undergoing surgery.
How much vinpocetine a dose includes varies substantially from manufacturer to manufacturer. A study published in Drug Testing and Analysis in 2015 determined that the daily recommended dose of vinpocetine in 23 supplements claiming to include it ranged from 0.32 to 32 mg in the 17 products that actually contained the ingredient. Six products that listed vinpocetine as an ingredient did not have any at all.
The appropriate regulatory treatment of vinpocetine has been a subject of ongoing debate. Germany, Russia, and China regulate vinpocetine as a prescription drug used to treat acute stroke and cognitive impairment in doses of 5 mg to 40 mg. Australia, New Zealand, and Canada ban supplements containing the ingredient.
As a dietary supplement in the United States, vinpocetine has not been regulated by the FDA. In 2016, the agency tentatively determined that the ingredient’s high level of processing did not meet its requirements for a dietary ingredient, but it did not take steps to remove or regulate it. The recent announcement indicated that the FDA would move quickly to complete the process started 3 years ago.
In the meantime, the FDA advised manufacturers and marketers of supplements containing vinpocetine to add warning labels to alert pregnant women and those who might become pregnant of the product’s risk. Products on the shelves and in the distribution chain now will not have these labels, so a discussion of the risks of vinpocetine with customers could save a life.
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