MHRAsafety guidance83% confidence
Domperidone: new contraindication in patients with phaeochromocytoma due to the risk of severe hypertension
Source: MHRA
Why This Matters
Why this matters: illustrates how regulators handled a comparable safety guidance decision relevant to Roche.
Regulatory Analysis
The product information has been updated for all domperidone products, to include a contraindication for patients with confirmed or suspected phaeochromocytoma (a rare tumour of the adrenal gland), due to the risk of episodes of severe hypertension.
Supporting Context
- Therapeutic area
- Oncology · CLL
- Sub-indication
- General
Related signal: Phase 2 Study of Mosunetuzumab in CLL Patients Post-BTKi Treatment