Which of the following medications is subject to a Risk Evaluation and Mitigation Strategy (REMS)...

ARisk Evaluation and Mitigation Strategy (REMS)program is required by theFDAfor certain medications that have serious safety concerns, ensuring their risks do not outweigh their benefits.Mycophenolateis subject to a REMS program due to its severe teratogenic effects.

(A) Sertraline❌Not Subject to REMS

Sertraline (Zoloft) is aSelective Serotonin Reuptake Inhibitor (SSRI)used to treat depression and anxiety.

While SSRIs can carry arisk of birth defects (such as persistent pulmonary hypertension in newborns - PPHN),sertraline is not included in the REMS program.

(B) Ondansetron❌Not Subject to REMS

Ondansetron (Zofran) is anantiemeticused to prevent nausea and vomiting.

While some studies suggest a possible increased risk of congenital defects, it isnot part of a REMS program.

(C) Montelukast❌Not Subject to REMS

Montelukast (Singulair) is aleukotriene receptor antagonist (LTRA)used forasthma and allergies.

It has aBoxed Warningfor mental health side effects butis not subject to a REMS program for pregnancy risks.

(D) Mycophenolate✅Correct – Subject to REMS

Mycophenolate (CellCept, Myfortic)is animmunosuppressantused to prevent organ rejection in transplant patients.

It carries ahigh risk of birth defects and miscarriage, making pregnancy preventionmandatorywhile taking the medication.

TheMycophenolate REMS Programrequires:

Mandatory counselingon pregnancy risks

Negative pregnancy testsbefore starting therapy

Use of effective contraceptionbefore, during, and after treatment

FDA REMS Program for Mycophenolate:https://www.mycophenolaterems.com/

FDA REMS Program Overview: https://www.fda.gov/drugs/risk-evaluation-and-mitigation-strategies-rems

PTCB Exam Content Outline – Medication Safety & Risk Management

Analysis of Answer Choices:References for Pharmacy Technicians: