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Priority review Notice Amended Final

Swissmedic: Lisdexamfetamine Contraindication for Pheochromocytoma Patients

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Published March 20th, 2026
Detected March 20th, 2026
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Summary

Swissmedic is updating the contraindications for lisdexamfetamine dimesylate to include patients with pheochromocytoma. This change aims to prevent potentially life-threatening increases in catecholamine levels. The product information for both healthcare professionals and patients will be amended to reflect this new contraindication.

What changed

Swissmedic has issued a Health Professional Communication (HPC) mandating an amendment to the contraindications for lisdexamfetamine dimesylate. The drug will now be contraindicated for patients diagnosed with pheochromocytoma, a condition involving tumors that can cause excessive catecholamine release. This update is necessary because sympathomimetic stimulants like lisdexamfetamine can exacerbate this condition, leading to potentially fatal consequences.

The product information for lisdexamfetamine dimesylate-containing medicines will be updated. Specifically, the 'Contraindications' section will include 'Pheochromocytoma,' and the patient information leaflet will add a warning against taking the medication if the patient suffers from this condition. This change requires immediate attention from drug manufacturers to update their labeling and from healthcare providers to ensure appropriate patient counseling and prescription practices.

What to do next

  1. Update product information for lisdexamfetamine dimesylate to include pheochromocytoma as a contraindication.
  2. Communicate this contraindication to healthcare professionals.
  3. Ensure patient information leaflets reflect the updated contraindication.

Source document (simplified)

Context sidebar

HPC – Lisdexamfetamindimesylat

Kontraindikation für Patienten mit Phäochromozytom

20.03.2026

Swissmedic möchte Sie über folgende Punkte informieren:

Zusammenfassung

  • Bei Patienten mit Phäochromozytom können sympathomimetische Stimulanzien, einschliesslich Lisdexamfetamindimesylat (LDX), den Anstieg zirkulierender Katecholamine verstärken und potenziell lebensbedrohliche Folgen haben.
  • Die Fachinformationen von Lisdexamfetamindimesylat-haltigen Arzneimitteln werden geändert. In der Rubrik „Kontraindikationen" wird „Phäochromozytom" aufgenommen.
  • Die Patienteninformationen von Lisdexamfetamindimesylat-haltigen Arzneimitteln werden geändert. In der Rubrik „Wann darf [Arzneimittelname ] nicht eingenommen werden?" wird „wenn Sie an einem Phäochromozytom leiden (ein seltener Tumor, der in der Regel in den Nebennieren wächst, die oberhalb der Nieren liegen)" ergänzt. Detaillierte Informationen dazu können dem PDF-Dokument entnommen werden.


- Swissmedic communication
HPC – Lisdexamfetamindimesylat (PDF, 149 kB, 20.03.2026)

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Named provisions

Kontraindikation für Patienten mit Phäochromozytom

Classification

Agency
Swissmedic
Published
March 20th, 2026
Instrument
Notice
Legal weight
Binding
Stage
Final
Change scope
Substantive
Document ID
HPC – Lisdexamfetamindimesylat

Who this affects

Applies to
Drug manufacturers Healthcare providers Patients
Industry sector
3254 Pharmaceutical Manufacturing
Activity scope
Drug Labeling Drug Safety
Geographic scope
CH CH

Taxonomy

Primary area
Pharmaceuticals
Operational domain
Compliance
Compliance frameworks
FDA 21 CFR Part 11 GxP
Topics
Drug Safety Medical Conditions

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