U.S. Food & Drug Administration

Activity Outline
FDA Drug Safety Podcast: Update on FDA’s ongoing evaluation of reports of suicidal thoughts or actions in patients taking a certain type of medicines approved for type 2 diabetes and obesity
April 9, 2024 - April 8, 2027

Activity Coordinators:

Kimberly De Fronzo (Kimberly.Defronzo@fda.hhs.gov), Ellicia Weber (Ellicia.Weber@fda.hhs.gov)

Description

This enduring material focuses on FDA's evaluation of reports of suicidal thoughts or actions in patients treated with glucagon-like peptide-1 receptor agonists (GLP-1 RAs). GLP-1 RAs are used to treat people with type 2 diabetes or to help those with obesity or overweight to lose weight. The presenter will discuss the preliminary evaluation and the limitations of the available data.

References

Sentinel: https://sentinelinitiative.org/news-events/fda-safety-communications-labeling-changes/update-fdas-ongoing-evaluation-reports
Drugs@FDA: FDA-Approved Drugs: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm
Drug Safety Communications: https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications
DailyMed: https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=GLP-1+RECEPTOR+AGONIST+%5BESTABLISHED+PHARMACOLOGIC+CLASS%5D

Learning Objectives

Explain the types of data analysis conducted during the preliminary evaluation.
Discuss FDA’s preliminary evaluation of reports of suicidal thoughts or actions in patients treated with glucagon-like peptide-1 receptor agonists (GLP-1 RAs).
Review recommendations for healthcare providers when treating patients with these medications .

Target Audience
This activity is intended for physicians, pharmacists, pharmacy technicians, nurses, Certified Public Health (CPH) Professionals, and physician assistants.

Registration Information
Registration is complimentary; therefore refunds are not applicable. For information on how to register to attend this activity, please contact the Activity Coordinator(s) listed above.

Continuing Education Accreditation

In support of improving patient care, FDA Center for Drug Evaluation and Research 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.

This activity was planned by and for the healthcare team, and learners will receive 0.5 Interprofessional Continuing Education (IPCE) credit(s) for learning and change.

CME

FDA Center for Drug Evaluation and Research designates this enduring material for a maximum of 0.50 AMA PRA Category 1 Credit(s)^™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

CPE

This knowledge-based activity has been assigned ACPE Universal Activity Number JA0002895-0000-24-052-H99-P, and ACPE Universal Activity Number JA0002895-0000-24-052-H99-T for 0.50 contact hour(s).

CNE

FDA Center for Drug Evaluation and Research designates this activity for 0.50 contact hour(s).

AAPA

FDA Center for Drug Evaluation and Research has been authorized by the American Academy of Physician Associates (AAPA) to award AAPA Category 1 CME credit for activities planned in accordance with AAPA CME Criteria. This activity is designated for 0.50 AAPA Category 1 CME credits. Approval is valid until April 8, 2027. PAs should only claim credit commensurate with the extent of their participation.

CPH

Up to 0.50 CPH Recertification Credits may be earned at this event.

Requirements for Receiving CE Credit

All learners claiming credit must attest to their attendance and complete all required activity evaluation(s) in the FDA CE Portal (ceportal.fda.gov) within 14 days after an activity ends. Upon completion, learners may view/print statement of credit.

Attention NABP Pharmacists and Pharmacy Technicians: The FDA CE Team will report your credit to the National Association of Boards of Pharmacy (NABP) provided you add your NABP ID and date of birth to your profile in the FDA CE Portal. The only official Statement of Credit is the one you pull from CPE Monitor®. If you do not see your credit reflected on CPE Monitor®* after 45 days of attestation, please contact FDACETeam@fda.hhs.gov.
*CPE Monitor® sets a strict 60-day limit on uploading credits.

Disclosure

Subject Matter Experts

Vu, Phi Phung, PharmD, Pharmacist, CDER - nothing to disclose

Faculty

Powers, Joan, Consumer Safety Officer, FDA - nothing to disclose

Planning Committee

Cao, Christian, MPAS, PA-C, Cross-Discipline Safety Advisor, FDA/CDER/OSE/OPE - nothing to disclose
De Fronzo, Kimberly, RPh, MS, MBA, Consumer Safety Officer, FDA/CDER/OCOMM/DDI - nothing to disclose
Kapoor, Rama, MD, Senior Physician, FDA - nothing to disclose
Lal, Renu, Pharm.D., Pharmacist, FDA - nothing to disclose
Paraoan, Dianne, MPH, BSN, RN, Associate Director for Regulatory Affairs, FDA/ CDER/ OMP - nothing to disclose
Vu, Phi Phung, PharmD, Pharmacist, CDER - nothing to disclose

CE Consultation and Accreditation Team

Bueide, Rachel E., MPhil, Training Specialist, FDA/CDER/OEP/DLOD - nothing to disclose
Bryant, Traci, M.A.T., Lead Training Specialist, FDA/CDER/OEP/DLOD - nothing to disclose
Wood, Sara, Accreditation Program Administrator, CECAT, FDA/CDER/OEP/DLOD - nothing to disclose

Any relationship shown above in italics has been divested within the last 24 months and is therefore considered mitigated.
All relevant financial relationships have been mitigated.

Requirements for Certificate of Completion (Non CE)
Must attend 100% of the activity.

Initial Release Date
April 9, 2024

Expiration Date
April 8, 2027

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