A child diagnosed with Dravet syndrome is receiving multi-drug anti-seizure therapy and is being considered for add-on treatment with fenfluramine. Which of the following monitoring strategies is most critical before initiating and during the course of this therapy, given the known pharmacological adverse-effect profile of fenfluramine?

Appeared in: INI-CET EXAM -2026

Explanation

Fenfluramine carries a black box warning for causing cardiac valvular disease and pulmonary arterial hypertension (PAH).
This severe adverse effect is linked to its metabolite, norfenfluramine, which can cause proliferative damage to heart valves and pulmonary artery cells.
Due to this risk, the drug is distributed under a strict Risk Evaluation and Mitigation Strategy (REMS) program.
The REMS program mandates baseline and serial echocardiography to monitor cardiac structure and function before and during therapy.

Option A: Agranulocytosis and aplastic anemia are severe hematologic side effects, but they are not the primary risk associated with fenfluramine.
Option C: Visual field defects are not a known adverse effect of fenfluramine.
Option D: While many drugs can affect the liver, severe hepatotoxicity is not the most critical or specific risk for fenfluramine.

Clinical Relevance

Nursing practice connection: Prioritize focused assessment, early escalation, and real-time monitoring when managing Pharmacological adverse effects and monitoring for fenfluramine in acute care settings.
Nurses are essential in the fenfluramine REMS program. Responsibilities include verifying that mandatory echocardiograms are completed on schedule and educating the family on the signs of heart failure or pulmonary hypertension (e.g., shortness of breath, fatigue, swelling in the ankles, chest pain).
Patient safety hinges on strict adherence to this monitoring protocol. A missed echocardiogram could lead to a delay in detecting life-threatening cardiac changes.
What if? If a child on fenfluramine develops new-onset fatigue and shortness of breath during play, the nurse's priority action is to perform a focused cardiopulmonary assessment and immediately notify the prescriber. This is a red flag for potential PAH or valvular disease, requiring urgent evaluation.

How to Approach the Question

First, identify the key drug in the question stem: fenfluramine.
Recall the most significant, life-threatening adverse effect associated with this specific drug. Fenfluramine is historically known for its link to heart and lung problems (from the 'fen-phen' era).
Evaluate each option based on this specific drug's profile. Option B directly addresses the known black box warning for fenfluramine (cardiac valvular disease and pulmonary hypertension).
Recognize the other options as 'classic' side effects of other common antiepileptic drugs.
Eliminate the distractors: Agranulocytosis points to carbamazepine, visual defects to vigabatrin, and hepatotoxicity to valproic acid.
Conclude that the most critical monitoring for fenfluramine is cardiac-related, making Option B the correct answer.

Concept Tested & Keywords

Concept Tested: Pharmacological adverse effects and monitoring for fenfluramine.
Stem keywords: Dravet syndrome, fenfluramine, add-on treatment, monitoring, adverse-effect
Lead-in keywords: most critical
Clinical cues: The specific drug mentioned, fenfluramine, has a well-known history of severe cardiopulmonary side effects, which is the key to answering the question.

QCIRqQWEcizfcppCyT4TaO

E6 Pharmacology Katzung 16e p. 669-671

E6 Nelson Textbook of Pediatrics(2024) — Volume 2 p. 1419-1421

Practise the full INI-CET EXAM -2026

Attempt every question from this paper in a timed mock, then review the full solution for each one.