lunes, 3 de junio de 2019

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

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

US FDA Masthead

Women's Health Alert



Message from the Acting Associate Commissioner

Dear Stakeholders,

Today, FDA issued a warning advising pregnant women and women who could become pregnant to not take dietary supplements containing vinpocetine due to possible reproductive safety risks. Please see link to full statement below for detailed information about this warning and to learn more about additional steps FDA is taking to protect the health of women


Today, the U.S. Food and Drug Administration 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 (NIH) National Toxicology Program (NTP), 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 today 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.

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