In case you missed it, the U.S. Food and Drug Administration recently warned that a compound in supplements marketed for weight loss, increased energy, and memory “may cause a miscarriage or harm fetal development.”
Obviously, women of childbearing age should stay away from vinpocetine — and there may be concerns for other people as well. Here’s an overview:
Vinpocetine is a man-made chemical, developed in the 1960s, that is similar to a substance in the leaves of Vinca minor, the periwinkle plant. Some basic science studies have been used to claim that vinpocetine has valuable effects in the brain, but definitive clinical trials have not been done.
In Europe, vinpocetine is available as a prescription drug to treat cognitive problems and cerebrovascular diseases. In the United States, it is marketed as a dietary supplement — but that’s stretching the definition of a supplement as spelled out in federal law.
Dietary supplements do not undergo FDA review for safety and effectiveness, and can make extravagant claims as long as they don’t explicitly promise to prevent or treat a disease. Vinpocetine, alone or with other ingredients, is marketed to burn fat, enhance memory and focus, sharpen eyesight, relieve menopausal symptoms, and more.
In 2016, the FDA published a Federal Register notice seeking comment on whether vinpocetine is legal for sale as a supplement. The action was prompted in part by a study that tested 26 products and found only six contained the amount of vinpocetine listed on the label. The agency now says it intends to “expedite completion” of the reevaluation.
Side effects of vinpocetine may include indigestion, nausea, dizziness, anxiety, facial flushing, insomnia, headache, drowsiness, slower blood clotting, and a temporary drop in blood pressure, according to WebMD.
Rigorous, long-term safety research in humans is lacking. But the FDA reviewed available data, including a recent report by the National Institutes of Health’s National Toxicology Program.
The program conducted studies in rats and rabbits to look for effects on fetal development. There was clear evidence that vinpocetine could trigger miscarriages. The compound also suppressed fetal growth and increased fetal heart and bone defects.
“The blood levels of vinpocetine in the pregnant animals were similar to those reported in people after taking a single dose of vinpocetine, indicating that pregnant women may experience adverse effects from vinpocetine,” the FDA warning said. “That’s why today we’re advising pregnant women and women who could become pregnant not to take vinpocetine.”
The FDA has directed supplement-makers to update product labeling accordingly. The agency also gave a shout-out to its new Dietary Supplements Ingredient Advisory List, a compilation of ingredients that “appear to be unlawfully marketed in dietary supplements.”