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Drug Safety Newsletter Issue 122: Hydroxycarbamide CGM Interference and Miconazole-Warfarin Interaction

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Summary

The HPRA Drug Safety Newsletter Issue 122 (April 2026) covers four safety topics for medicines for human use: potential interference of hydroxycarbamide-containing products with continuous glucose monitoring systems; a drug-drug interaction between topical miconazole and warfarin; the importance of reporting suspected adverse reactions to pharmacovigilance; and updates from EMA's PRAC. The newsletter also references Direct Healthcare Professional Communications published on the HPRA website since the prior issue.

“The latest edition of the HPRA newsletter includes important updates to support the safe and appropriate use of the following medicines:”

Published by HPRA Ireland on hpra.ie . Detected, standardized, and enriched by GovPing. Review our methodology and editorial standards .

What changed

The newsletter announces updated safety information on two specific drug interaction risks: hydroxycarbamide-containing products may interfere with continuous glucose monitoring system readings, and topical miconazole formulations can interact with warfarin therapy. These are communicated alongside broader pharmacovigilance reporting reminders and a summary of EMA PRAC product information updates.\n\nHealthcare providers and pharmaceutical companies should note these safety communications for incorporation into relevant prescribing and dispensing guidance. The HPRA's inclusion of DHPCs published since the last issue signals ongoing monitoring activity that affected parties should track on the HPRA website.

Archived snapshot

Apr 20, 2026

GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.

Back to safety notices

HPRA Drug Safety Newsletter Issue 122 08 April 2026

08/04/2026 Medicines for human use Safety update

The latest edition of the HPRA newsletter includes important updates to support the safe and appropriate use of the following medicines:

  • Hydroxycarbamide-containing medicinal products: Potential interference with continuous glucose monitoring systems

  • Miconazole: Drug-drug interaction between miconazole topical formulations and warfarin

  • Reporting suspected adverse reactions: The importance of reports of suspected adverse reactions to pharmacovigilance

  • Product information updates recommended by the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC)

  • Direct Healthcare Professional Communications published on the HPRA website since the last Drug Safety Newsletter

Documents

Drug Safety Newsletter Issue 122 April 2026 PDF : 232KB | 08/04/2026

Named provisions

Hydroxycarbamide CGM interference Miconazole-warfarin interaction Pharmacovigilance reporting PRAC updates

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Last updated

Classification

Agency
HPRA Ireland
Published
April 8th, 2026
Instrument
Notice
Branch
Executive
Legal weight
Non-binding
Stage
Final
Change scope
Minor
Document ID
HPRA DSN-122

Who this affects

Applies to
Pharmaceutical companies Healthcare providers
Industry sector
3254 Pharmaceutical Manufacturing
Activity scope
Drug safety monitoring Pharmacovigilance reporting Adverse reaction tracking
Geographic scope
Ireland IE

Taxonomy

Primary area
Pharmaceuticals
Operational domain
Clinical Operations
Compliance frameworks
GxP
Topics
Medical Devices Public Health

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