Supplementary ingredient causing miscarriage and fetal harm

Scientists say this ingredient can increase the risk of miscarriage or impair fetal development in pregnant animals. And they worry the same could be true for pregnant women. So, the FDA is advising pregnant women or women who could become pregnant not to take supplements containing this compound.

Vinpocetine – A supplement causing miscarriages and fetal harms

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. Because it is indicating that pregnant women may experience adverse effects from vinpocetine similar to those seen in the pregnant animals.

By any name, this supplement may cause harm to pregnant women

FDA is responsible for taking action against any misbrand dietary supplement product after it reaches the market.

A report from the National Toxicology Program of the National Institutes of Health

Manufacturers and distributors of dietary supplements and dietary ingredients are

responsible for evaluating the safety and labeling of their products before marketing

FDA website

to ensure that they meet all federal requirements.

The warning comes after the Agency reviewed a report by the National Institute of Health’s (NIH) National Toxicology Program (NTP) which evaluated the “developmental and/or reproductive toxicity of selected substances in laboratory animals.” Results showed vinopocetine decreased fetal weight and increased the chance for miscarriage in pregnant animals. As the blood levels of vinpocetine measured in the animals were similar to those reported in individuals who consumed a single dose of vinpocetine, it can inferred that the risks would apply to humans as well.

Also read about how high fiber diet can help many diseases during pregnancy

FDA

The FDA is also advising marketing firms to ensure their products contain safety warning on the labels. In some countries, vinpocetine treated like a prescription drug but not here in the United States where dietary supplements are not strictly regulated by the FDA.

Laws that regulate supplements are suppose to govern products that are derived from or subcategories of foods, like vitamins and minerals.

It’s not supposed to be a backdoor to introduce pharmacological drugs to consumers without FDA approval

Cohen

That poses a risk to consumers, because unlike pharmaceuticals, supplements aren’t formally studied for safety. And efficacy they’re under much less stringent oversight. For example, a pharmaceutical drug must undergo multiple phases of clinical trials. Which include giving the drug to large and diverse groups of people. And as well as targeted groups with a specific disorder the drug is meant to treat. In addition, since vinpocetine can be sold over the counter, researchers and pharmaceutical companies are unlikely to study the substance, even though it might have a useful medical purpose.

Who is going to spend money to do clinical trials when people can buy [it] over the counter? It’s a huge disincentive to study the drug. No company would spend the money to do the studies.

Cohen

In 2016, the FDA announced that it was re-considering vinpocetine’s classification as a supplement. Cohen speculates that’s why the FDA highlighted this particular NTP report: The results could have more of an impact. Vinpocetine isn’t necessarily widely used by people who could become pregnant, specifically—cognitive enhancers are, broadly speaking, primarily used by the elderly and people in the tech industry interested in improving focus.

Cohen

I suspect the FDA decided, let’s take a deeper dive into safety, and see if in addition to it being a pharmaceutical, what are the biggest safety concerns.

Cohen

The NTP regularly studies dietary supplements—because there isn’t much safety research done on supplements, their work fills the gap, wrote a spokesperson from the National Institute of Environmental Health Sciences, which houses the program, in an email to Popular Science. However, most of their reports, regardless of findings, aren’t accompanied by a warning from the FDA, Cohen says.

Conclusions

More than half of all Americans take at least one dietary supplement on a regular basis, according to the agency.  In some countries, vinpocetine treated like a prescription drug but not in the United States where dietary supplements are not strictly regulated by the FDA. Scientists say this ingredient can increase the risk of miscarriage. To help ensure your own and your family’s safety, check advisory list before purchasing dietary supplements. 

Here are some good books that can help you get aware about some other facts leading to miscarriages.

• It Starts with the Egg: How the Science of Egg Quality Can Help You Get Pregnant Naturally, Prevent Miscarriage, and Improve Your Odds in IVF
• The Pregnant Body Book: The Complete Illustrated Guide from Conception to Birth
• Not Broken: An Approachable Guide to Miscarriage and Recurrent Pregnancy Loss
• Trying Again: A Guide to Pregnancy After Miscarriage, Stillbirth, and Infant Loss