Expert Consultations: Real-World Answers

Prescribing in Pregnancy: What Every Psychiatrist Should Know – Interview

Published on June 1, 2025 Certification expiration date: June 1, 2028 DOI: 10.64239/PI-EC081

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Helen Tellegen, P.M.H.N.P.

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FDA Medication Risk Categories in Pregnancy

Helen Tellegen, PMHNP: The FDA discontinued the ABCDX risk categories for medications in pregnancy due to their oversimplification. What important considerations were missing from this system that could help prescribers make more informed decisions?

Amanda Koire, M.D.: The ABCDX risk categories had a fundamental flaw in that medications with minimal safety data often appeared to be the safest options.

This is analogous to choosing a restaurant based solely on star ratings without considering the number of reviews.

The category system had several issues:

It considered some medications as a class, even though they had different amounts of safety data at an individual level.
Concerning animal data made it difficult to change the designation, even in the presence of reassuring human data.
The system did not reflect the nuanced nature of the available information.

The new Pregnancy and Lactation Labeling Rule (PLLR) system provides relevant

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Learning Objectives

After completing this activity, the learner will be able to:

Evaluate the risks and benefits of psychiatric medications during pregnancy using contemporary evidence-based approaches.
Implement appropriate monitoring and dosing adjustments for psychiatric medications throughout pregnancy and the postpartum period.
Develop effective communication strategies for discussing medication management decisions with pregnant patients.

Activity

Original Release Date: June 1, 2025
Expiration Date: June 1, 2028
Expert: Amanda Koire, M.D., Ph.D.
Medical Editors: Flavio Guzmán, M.D. & Helen Tellegen, P.M.H.N.P.

Relevant Financial Disclosures:

None of the faculty, planners, and reviewers for this educational activity has relevant financial relationships to disclose during the last 24 months with ineligible companies whose primary business is producing, marketing, selling, re-selling, or distributing healthcare products used by or on patients.

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Accreditation

Physicians

Accreditation Statement:
This activity has been planned and implemented in accordance with the accreditation requirements and policies of the Accreditation Council for Continuing Medical Education through the joint providership of Medical Academy LLC and the Psychopharmacology Institute. Medical Academy is accredited by the ACCME to provide continuing medical education for physicians.

Credit Designation Statement:
Medical Academy designates this enduring activity for a maximum of 0.5 AMA PRA Category 1 credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Nursing professionals — The ANCC accepts AMA PRA Category 1 Credit(s)™ as Contact Hours, under this calculation: 1 CME = 1 Contact Hour. All of our content is psychopharmacology, so the pharmacology hours shown on your certificate match the credits awarded for that activity. Your certificate states them on their own line, separately from the credit designation statement. This applies to APRN pharmacology renewal as well. Boards of nursing define pharmacology CE in their own way, so please confirm with your board that this is the documentation they expect.

Physician assistants — The NCCPA accepts AMA PRA Category 1 Credit™ from providers accredited by the ACCME toward PA certification maintenance. Requirements are set by the NCCPA, so please confirm with them what your current cycle requires.

Physicians outside the United States — AMA PRA Category 1 Credit™ may be awarded to physicians regardless of where they are licensed. Physicians interested in converting AMA PRA Category 1 Credit™ to UEMS-European Accreditation Council for Continuing Medical Education CME credits (ECMEC®s) should contact the UEMS at mutualrecognition@uems.eu. Acceptance toward a national continuing education requirement is determined by each country’s own authority.

Artificial Intelligence (AI) Use Disclosure

Artificial intelligence (AI) tools may have been used in limited stages of developing this activity (e.g., drafting or language refinement). The specific tool, version, and date of use are documented internally. AI is used solely as an editorial support mechanism and does not replace human expertise. AI does not determine clinical recommendations. All content is reviewed, verified, and approved by the listed experts and medical editors, and reflects independent human clinical judgment consistent with ACCME Standards for Integrity and Independence in Accredited Continuing Education.