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Regulatory Focus™ > News Articles > 2019 > 6 > FDA Warns Pregnant Women Not to Take Vinpocetine

FDA Warns Pregnant Women Not to Take Vinpocetine

Posted 03 June 2019 | By Zachary Brennan 

FDA Warns Pregnant Women Not to Take Vinpocetine

The US Food and Drug Administration (FDA) on Monday issued a warning that consumption of the dietary supplement vinpocetine is associated with adverse reproductive effects.

The FDA warning comes as a rat study conducted by the National Institutes of Health’s National Toxicology Program (NTP) found that vinpocetine decreased fetal weight and increased the chances of a miscarriage.

“The blood levels of vinpocetine measured 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 similar to those seen in the pregnant animals,” FDA said.

The agency, which explains that it has not reviewed vinpocetine products that are sold in the US, also said such products may be referred to on product labels as, “Vinca minor extract, lesser periwinkle extract, or common periwinkle extract. Dietary supplements containing vinpocetine are often marketed for uses that include enhanced memory, focus, or mental acuity; increased energy; and weight loss.”

In the 1990s, FDA received several new dietary ingredient notifications for vinpocetine, but it wasn’t until 2016 when FDA requested comment from stakeholders as part of an evaluation of whether vinpocetine is legal for sale as a dietary supplement.

“With the results in NTP’s report, it was important to issue today’s warning because the availability of dietary supplement products containing vinpocetine has grown and the labels of vinpocetine products often have no warnings about the dangers of miscarriage and harm to fetal development. For the same reasons, the FDA will expedite completion of the administrative proceeding that we began in September 2016,” the agency said.

The warning on vinpocetine follows FDA’s February release of 12 warning letters and five advisory letters to foreign and domestic companies that are illegally selling more than 58 unapproved new drugs and/or misbranded drugs that claim to prevent, treat or cure Alzheimer’s disease and a number of other serious diseases and health conditions.

Statement on warning for women of childbearing age about possible safety risks of dietary supplements containing vinpocetine

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