Vinpocetine FDA Status: The 2019 Warning and What It Means for SonoVive

FDA said two things. Women who are pregnant, or who could become pregnant, should not take it. And it does not count as a dietary ingredient in FDA's view.

The warning came out on June 3, 2019. FDA wrote that vinpocetine "is associated with adverse reproductive effects," which it described as miscarriage and harm to an unborn baby (FDA vinpocetine). The same FDA page repeats an earlier view: "Vinpocetine does not meet the definition of a dietary ingredient." FDA first reached that view in 2016 and still calls it tentative.

Both points matter for SonoVive, which names vinpocetine among its five ingredients. If you are buying it for yourself or a parent, settle the vinpocetine question first.

If something feels wrong after you start any supplement, stop it, call your doctor, and report it to FDA MedWatch at 800-FDA-1088 (FDA MedWatch).

1. Vinpocetine in Dietary Supplements. U.S. Food and Drug Administration, 2019.June 3, 2019 warning: vinpocetine "is associated with adverse reproductive effects" (miscarriage, fetal harm); pregnant women and women who could become pregnant should not take it. FDA states "Vinpocetine does not meet the definition of a dietary ingredient" (tentative 2016 conclusion).
2. Vinpocetine (About Herbs). Memorial Sloan Kettering Cancer Center, 2021.Systematic review found no Alzheimer's benefit. Developed in Europe as a drug. May increase bleeding with anticoagulants and add to blood-pressure drugs; flushing, rash, GI upset, low blood pressure; one agranulocytosis case; NTP data suggest harm in pregnancy.
3. Cognitive Vitality Report: Vinpocetine. Alzheimer's Drug Discovery Foundation, not stated (cites to 2015).Trial doses 5-60 mg/day; 30-60 mg showed benefit in dementia trials while 15 mg did not; "The available evidence does not appear strong enough to support clinical implementation." Avoid with blood thinners and in pregnancy.
4. Vinpocetine for cognitive impairment and dementia (CD003119). Szatmari SZ, Whitehouse PJ; Cochrane, 2003.3 studies, 583 people with dementia: evidence is "inconclusive and does not support clinical use."
5. Questions and Answers on Dietary Supplements. U.S. Food and Drug Administration, current."Under DSHEA, FDA does not have the authority to approve dietary supplements before they are marketed." Manufacturers and distributors have initial responsibility for safety.
6. Dietary Supplements: What You Need to Know. NIH Office of Dietary Supplements, 2023.Supplements can interact with some medicines; some can increase bleeding risk or change response to anesthesia if taken before surgery. FDA does not determine whether supplements are effective before they are marketed. Report problems to FDA at 800-FDA-1088.
7. MedWatch: The FDA Safety Information and Adverse Event Reporting Program. U.S. Food and Drug Administration, current.Consumers can report adverse events online through the MedWatch "Report a Problem" form.