其 他 安 全 警 示
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| The United States: Statement on warning for women of childbearing age about possible safety risks of dietary supplements containing vinpocetine (English Only) |
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The US Food and Drug Administration (FDA) is warning consumers about safety concerns regarding an ingredient called vinpocetine that is found in dietary supplements, specifically concerns about the use of this ingredient by women of childbearing age. According to data reviewed by the FDA, including a recent report by the National Institute of Health’s National Toxicology Program, consumption of vinpocetine is associated with adverse reproductive effects – in other words, vinpocetine may cause a miscarriage or harm fetal development.
These findings are particularly concerning since products containing vinpocetine are widely available for use by women of childbearing age. That’s why the FDA is advising pregnant women and women who could become pregnant not to take vinpocetine. The FDA is 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.
Vinpocetine is a synthetically produced compound that is used in some products marketed as dietary supplements, either by itself or combined with other ingredients. Vinpocetine 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. Scientists who have studied the effects of vinpocetine on pregnant animals concluded 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.
In some countries outside of the US, vinpocetine is regulated as a prescription drug. When products like vinpocetine are sold as dietary supplements in the US, they have not been reviewed by the FDA under the safety and effectiveness standards that apply to drug products. This means that the FDA has not reviewed each vinpocetine product, or its labeling, before those products become available to consumers.
Please refer to the following website in FDA for details:
http://www.fda.gov/news-events/press-announcements/statement-warning-women-childbearing-age-about-possible-safety-risks-dietary-supplements-containing
In Hong Kong, there is no registered pharmaceutical product containing vinpocetine.
Ends/Tuesday, Jun 4, 2019
Issued at HKT 16:00
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