FDA News

FDA issues warning for vinpocetine

The FDA said it was warning women of childbearing age about the synthetically produced compound vinpocetine found in dietary supplements or as a stand-alone product.

The agency also said it was encouraging companies that market products containing vinpocetine to check their product labeling to assure that it provides safety warnings against use by pregnant women and women who could become pregnant.

An NIH analysis showed consuming vinpocetine could cause miscarriage or harm fetal development, Amy Abernethy MD, PhD, FDA principal deputy commissioner, and Frank Yiannas, FDA deputy commissioner for food policy and response, said in a statement. They added that the blood levels of vinpocetine measured in pregnant animals were similar to those reported in someone who took a single dose of vinpocetine.

Pregnant Woman 
The FDA said it was warning women of childbearing age about the synthetically produced compound vinpocetine found in dietary supplements or as a stand-alone product.

Source:Shutterstock

According to the FDA, vinpocetine is sometimes called Vinca minor extract, lesser periwinkle extract or common periwinkle extract on product labels and is often contained in products marketed to increase memory, focus or mental acuity, help with weight loss or increase energy. In some locations outside the United States, it is regulated as a prescription drug.

Abernethy and Yiannas noted that about 20 years ago, the FDA received several premarket safety submissions for vinpocetine as an ingredient in dietary supplements, and that in 2016, the FDA requested comment from the product’s stakeholders to ascertain whether vinpocetine can legally be sold as a dietary supplement. The agency is seeking to resolve the 2016 issues as quickly as possible, according to the statement.

Disclosures: Abernethy and Yiannas are employed by the FDA.

 

The FDA said it was warning women of childbearing age about the synthetically produced compound vinpocetine found in dietary supplements or as a stand-alone product.

The agency also said it was encouraging companies that market products containing vinpocetine to check their product labeling to assure that it provides safety warnings against use by pregnant women and women who could become pregnant.

An NIH analysis showed consuming vinpocetine could cause miscarriage or harm fetal development, Amy Abernethy MD, PhD, FDA principal deputy commissioner, and Frank Yiannas, FDA deputy commissioner for food policy and response, said in a statement. They added that the blood levels of vinpocetine measured in pregnant animals were similar to those reported in someone who took a single dose of vinpocetine.

Pregnant Woman 
The FDA said it was warning women of childbearing age about the synthetically produced compound vinpocetine found in dietary supplements or as a stand-alone product.

Source:Shutterstock

According to the FDA, vinpocetine is sometimes called Vinca minor extract, lesser periwinkle extract or common periwinkle extract on product labels and is often contained in products marketed to increase memory, focus or mental acuity, help with weight loss or increase energy. In some locations outside the United States, it is regulated as a prescription drug.

Abernethy and Yiannas noted that about 20 years ago, the FDA received several premarket safety submissions for vinpocetine as an ingredient in dietary supplements, and that in 2016, the FDA requested comment from the product’s stakeholders to ascertain whether vinpocetine can legally be sold as a dietary supplement. The agency is seeking to resolve the 2016 issues as quickly as possible, according to the statement.

Disclosures: Abernethy and Yiannas are employed by the FDA.