FDA Releases Warning Regarding Dietary Supplement Vinpocetine and Fetal Safety Risk
Learning Objectives and CME/Disclosure Information
This activity is intended for healthcare providers delivering care to women and their families.
After completing this activity, the participant should be better able to:
1. Describe vinpocetine, including common product label names and potential fetal risks 2. Discuss steps that the FDA is undertaking to prevent the use of vinpocetine in women of childbearing age
Estimated time to complete activity: 0.25 hours
Susan J. Gross, MD, FRCSC, FACOG, FACMG President and CEO, The ObG Project
Disclosure of Conflicts of Interest
Postgraduate Institute for Medicine (PIM) requires instructors, planners, managers and other individuals who are in a position to control the content of this activity to disclose any real or apparent conflict of interest (COI) they may have as related to the content of this activity. All identified COI are thoroughly vetted and resolved according to PIM policy. PIM is committed to providing its learners with high quality CME activities and related materials that promote improvements or quality in healthcare and not a specific proprietary business interest of a commercial interest.
Faculty: Susan J. Gross, MD, receives consulting fees from Cradle Genomics, and has financial interest in The ObG Project, Inc.
Planners and Managers: The PIM planners and managers, Trace Hutchison, PharmD, Samantha Mattiucci, PharmD, CHCP, Judi Smelker-Mitchek, MBA, MSN, RN, and Jan Schultz, MSN, RN, CHCP have nothing to disclose.
Method of Participation and Request for Credit
Fees for participating and receiving CME credit for this activity are as posted on The ObG Project website. During the period from 7/1/2019 through 7/1/2021, participants must read the learning objectives and faculty disclosures and study the educational activity.
If you wish to receive acknowledgment for completing this activity, please complete the post-test and evaluation. Upon registering and successfully completing the post-test with a score of 100% and the activity evaluation, your certificate will be made available immediately.
For Pharmacists: Upon successfully completing the post-test with a score of 100% and the activity evaluation form, transcript information will be sent to the NABP CPE Monitor Service within 4 weeks.
Joint Accreditation Statement
In support of improving patient care, this activity has been planned and implemented by the Postgraduate Institute for Medicine and The ObG Project. Postgraduate Institute for Medicine is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.
Physician Continuing Medical Education
Postgraduate Institute for Medicine designates this enduring material for a maximum of 0.25 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
Continuing Nursing Education
The maximum number of hours awarded for this Continuing Nursing Education activity is 0.2 contact hours.
Designated for 0.1 contact hours of pharmacotherapy credit for Advance Practice Registered Nurses.
The FDA issued a statement (June 2019) warning women of childbearing age about possible safety risks of dietary supplements containing vinpocetine. The FDA states
…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.
Synthetically produced compound
Marketed as dietary supplements, alone or in combination
Product label names
Vinca minor extract
Lesser periwinkle extract
Common periwinkle extract
Marketed to enhance
Memory | Focus | Mental acuity
Potential harms (animal studies), reviewed by NIH National Toxicology Program (NTP)
Decreased fetal weight
Increased miscarriage risk
Blood levels in pregnant animals are similar to human levels following a single dose
Products that are currently on the market and readily available
FDA is advising firms to evaluate their product labeling to ensure that it provides safety warnings against use by pregnant women and women who could become pregnant
Vinpocetine is a prescription drug in some countries outside the US
If sold in the US as a dietary supplement, they have not been reviewed by the FDA under the safety and effectiveness standards that apply to drug products
The dietary supplement industry has grown ten-fold over the past 25 years
Over 50% of Americans take at least one dietary supplement regularly
FDA released the Dietary Supplement Ingredient Advisory List (April 2019), to alert the public of unlawful ingredient marketing
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Disclosure of Unlabeled Use
This educational activity may contain discussion of published and/or investigational uses of agents that are not indicated by the FDA. The planners of this activity do not recommend the use of any agent outside of the labeled indications.
The opinions expressed in the educational activity are those of the faculty and do not necessarily represent the views of the planners. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications, and warnings.
Participants have an implied responsibility to use the newly acquired information to enhance patient outcomes and their own professional development. The information
presented in this activity is not meant to serve as a guideline for patient management. Any procedures, medications, or other courses of diagnosis or treatment discussed or suggested in this activity should not be used by clinicians without evaluation of their patient’s conditions and possible contraindications and/or dangers in use, review of any applicable manufacturer’s product information, and comparison with recommendations of other authorities.
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