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June 11, 2019
Here’s an important alert for women of childbearing age who are taking dietary supplements containing vinpocetine.
On June 3, the Food and Drug Administration (FDA) issued a statement warning women of childbearing age about safety concerns regarding vinpocetine, an ingredient found in many widely available dietary supplements.[1] The agency’s warning was prompted by data from animal research conducted by the National Institutes of Health’s (NIH’s) National Toxicology...
June 11, 2019
Here’s an important alert for women of childbearing age who are taking dietary supplements containing vinpocetine.
On June 3, the Food and Drug Administration (FDA) issued a statement warning women of childbearing age about safety concerns regarding vinpocetine, an ingredient found in many widely available dietary supplements.[1] The agency’s warning was prompted by data from animal research conducted by the National Institutes of Health’s (NIH’s) National Toxicology Program, which showed that vinpocetine may cause miscarriage and harm fetal development. The FDA advised “pregnant women and women who could become pregnant not to take vinpocetine.” The agency also asked companies that manufacture dietary supplements containing vinpocetine to ensure that labeling of these products provides similar safety warnings.
Vinpocetine is a synthetic compound derived from certain naturally occurring substances found in a type of plant called Vinca minor L. and in Voacanga seeds.[2] Importantly, vinpocetine is not a natural component of these plants or any other plants. As a result, the FDA in 2016 announced its tentative conclusion that vinpocetine does not meet the legal definition of a dietary ingredient and is excluded from the definition of a dietary supplement. However, the FDA has since failed to take appropriate regulatory action to ban the use of vinpocetine in dietary supplements.
Vinpocetine is sold in dietary supplements by itself and in combination with other ingredients.[3] It may be referred to on product labeling by other names, including Vinca minor extract, lesser periwinkle extract and common periwinkle extract. In some foreign countries, vinpocetine is regulated as a prescription medication.
According to the NIH’s National Toxicology Program, vinpocetine is marketed in the U.S. as a dietary supplement primarily to enhance cognitive function in patients with Alzheimer’s disease, dementia and ischemic stroke.[4] It also currently is promoted as a brain supplement for students to improve cognitive performance. Additionally, healthy athletes within the bodybuilding community use vinpocetine to reduce body fat and to enhance visual acuity, memory and focus. Other reported uses include treatment of urinary incontinence, tinnitus (ringing sensation in the ears), visual impairment, menopause symptoms, chronic fatigue syndrome and seizures, and prevention of motion sickness. As with all dietary supplements, the FDA has not assessed the safety and effectiveness of vinpocetine for any of these uses.
In studies sponsored by the NIH’s National Toxicology Program, scientists exposed pregnant rats to vinpocetine. These studies showed that the substance caused miscarriages and fetal abnormalities involving the heart and skeleton in the rats.[5] In its assessment of the data, the FDA noted that the blood levels of vinpocetine measured in the pregnant rats “were similar to those reported in people after taking a single dose of vinpocetine, indicating that pregnant women may experience [similar] adverse effects.”[6]
In its June 3 statement, the FDA indicated that it now plans to “expedite completion of the administrative proceeding” regarding the agency’s tentative conclusion in 2016 that vinpocetine does not meet the legal definition of a dietary ingredient and is excluded from the definition of a dietary supplement.[7]
What You Can Do
Do not use dietary supplements containing vinpocetine (or Vinca minor extract, lesser periwinkle extract and common periwinkle extract), particularly if you are a woman who is pregnant or could become pregnant.
To see the FDA’s statement, visit the following link: https://www.fda.gov/news-events/press-announcements/statement-warning-women-childbearing-age-about-possible-safety-risks-dietary-supplements-containing.
References
[1] Food and Drug Administration. Statement on warning for women of childbearing age about possible safety risks of dietary supplements containing vinpocetine. June 3, 2019. https://www.fda.gov/news-events/press-announcements/statement-warning-women-childbearing-age-about-possible-safety-risks-dietary-supplements-containing. Accessed June 11, 2019.
[2] Food and Drug Administration. Vinpocetine in dietary supplements. June 3, 2019. https://www.fda.gov/food/dietary-supplement-products-ingredients/vinpocetine-dietary-supplements. Accessed June 11, 2019.
[3] Food and Drug Administration. Statement on warning for women of childbearing age about possible safety risks of dietary supplements containing vinpocetine. June 3, 2019. https://www.fda.gov/news-events/press-announcements/statement-warning-women-childbearing-age-about-possible-safety-risks-dietary-supplements-containing. Accessed June 11, 2019.
[4] National Institutes of Health, National Toxicology Program. Peer Review Draft NTP Technical Report on the Prenatal Developmental Toxicity Study of Vinpocetine (CAS No. 42971-09-5) in Sprague Dawley (Hsd:Sprague Dawley SD) Rats and New Zealand White (Hra:NZW SPF) Rabbits (Gavage Studies). Scheduled peer review date: 2019. https://ntp.niehs.nih.gov/ntp/about_ntp/trpanel/2019/july/dart03_508.pdf. Accessed June 11, 2019.
[5] Ibid.
[6] Food and Drug Administration. Statement on warning for women of childbearing age about possible safety risks of dietary supplements containing vinpocetine. June 3, 2019. https://www.fda.gov/news-events/press-announcements/statement-warning-women-childbearing-age-about-possible-safety-risks-dietary-supplements-containing. Accessed June 11, 2019.
[7] Ibid.
