FDA Releases Warning Regarding Dietary Supplement Vinpocetine and Fetal Safety Risk
The FDA issued a statement (June 2019) warning women of childbearing age about possible safety risks of dietary supplements containing vinpocetine. The FDA states
…we’re advising pregnant women and women who could become pregnant not to take vinpocetine. We are also advising firms marketing dietary supplements containing vinpocetine to evaluate their product labeling to ensure that it provides safety warnings against use by pregnant women and women who could become pregnant.
Synthetically produced compound
Marketed as dietary supplements, alone or in combination
Product label names
Vinca minor extract
Lesser periwinkle extract
Common periwinkle extract
Marketed to enhance
Memory | Focus | Mental acuity
Potential harms (animal studies), reviewed by NIH National Toxicology Program (NTP)
Decreased fetal weight
Increased miscarriage risk
Blood levels in pregnant animals are similar to human levels following a single dose
Products that are currently on the market and readily available
FDA is advising firms to evaluate their product labeling to ensure that it provides safety warnings against use by pregnant women and women who could become pregnant
Vinpocetine is a prescription drug in some countries outside the US
If sold in the US as a dietary supplement, they have not been reviewed by the FDA under the safety and effectiveness standards that apply to drug products
The dietary supplement industry has grown ten-fold over the past 25 years
Over 50% of Americans take at least one dietary supplement regularly
FDA released the Dietary Supplement Ingredient Advisory List (April 2019), to alert the public of unlawful ingredient marketing
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