*Product associated with death, disability, hospitalisation in children, young adults
An ingredient found in dietary supplements may cause a miscarriage or harm foetal development, the US Food and Drug Administration (FDA) warned women of childbearing age on Monday. Vinpocetine, a synthetically produced compound sold by itself or combined with other ingredients, is usually marketed for increased cognitive performance, enhanced energy and rapid reduction of body fat.
Product labels may refer to vinpocetine as “Vinca minor extract,” “lesser periwinkle extract,” or “common periwinkle extract.”
By any name, this supplement may cause harm to pregnant women, a report from the National Toxicology Programme of the National Institutes of Health suggests.
Vinpocetine decreased fetal weight and increased the chances of a miscarriage in test animals, according to the report. Blood levels 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. Toxicology tests also proved that in a significant number of products, the actual content of vinpocetine varied from what was stated on the label; this could result in higher doses than what is recommended.
All of these findings are “concerning since products containing vinpocetine are widely available for use by women of childbearing age,” stated Principal Deputy Commissioner Dr. Amy Abernethy and Deputy Commissioner for Food Policy and Response Frank Yiannas, both of the FDA, in their warning to women.
Manufacturers and distributors of dietary supplements and dietary ingredients are “responsible for evaluating the safety and labeling of their products before marketing” to ensure that they meet all federal requirements, according to the agency’s website. “FDA is responsible for taking action against any adulterated or misbranded dietary supplement product after it reaches the market.” This means the FDA has not reviewed each individual vinpocetine dietary supplement or its labeling before the product has become available to consumers.
Meanwhile, consumption of dietary supplements sold for weight loss, muscle building, and energy was associated with increased risk for severe medical events in children and young adults compared to consumption of vitamins, according to new research led by Harvard T.H. Chan School of Public Health, United States (U.S.). The study found that, compared with vitamins, these types of supplements were linked to nearly three times as many severe medical outcomes in young people.
Lead author Flora Or, a researcher with Harvard Chan School’s Strategic Training Initiative for the Prevention of Eating Disorders, said: “The United States Food and Drug Administration (FDA) has issued countless warnings about supplements sold for weight loss, muscle building or sport performance, sexual function, and energy, and we know these products are widely marketed to and used by young people. So what are the consequences for their health? That’s the question we wanted to answer.”
The study was published online June 5, 2019 in the Journal of Adolescent Health.
The researchers looked at adverse event reports between January 2004 and April 2015 in the FDA Adverse Event Reporting System on the food and dietary supplements database. They analyzed the relative risk for severe medical events such as death, disability, and hospitalization in individuals aged 0 and 25 years that were linked with the use of dietary supplements sold for weight loss, muscle building, or energy compared to vitamins.
They found that there were 977 single-supplement-related adverse event reports for the target age group. Of those, approximately 40 per cent involved severe medical outcomes, including death and hospitalization. Supplements sold for weight loss, muscle building, and energy were associated with almost three times the risk for severe medical outcomes compared to vitamins. Supplements sold for sexual function and colon cleanse were associated with approximately two times the risk for severe medical outcomes compared to vitamins.
Senior author S. Bryn Austin, professor in the Department of Social and Behavioral Sciences, noted that reputable physicians do not recommend the use of the type of dietary supplements analyzed in this study. Many of these products have been found to be adulterated with prescription pharmaceuticals, banned substances, heavy metals, pesticides, and other dangerous chemicals. And other studies have linked weight-loss and muscle-building supplements with stroke, testicular cancer, liver damage, and even death.
“How can we continue to let the manufacturers of these products and the retailers who profit from them play Russian roulette with America’s youth?” Austin said. “It is well past time for policymakers and retailers to take meaningful action to protect children and consumers of all ages.”
Yongjoo Kim of Harvard Chan School was also a co-author.
This study was funded by the Ellen Feldberg Gordon Fund for Eating Disorders Prevention Research and the Strategic Training Initiative for the Prevention of Eating Disorders.