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PRAC recommendations on signals adopted at the  9–12 March 2026 PRAC meeting

April 8, 2026

New aspect of a known risk (aseptic meningitis in healthy young adults following live attenuated chikungunya vaccination), a new adverse reaction for an established acetylcholinesterase inhibitor (nightmares with galantamine), and a request for supplementary information on the increased risk of ectopic pregnancy with lower-dose levonorgestrel intrauterine devices (13.5 mg).

The EPVC Newsletter (Volume 20, Issue 3- March 2026)

April 5, 2026

A label update from the New Zealand regulatory authority (Medsafe) regarding Pisa syndrome associated with donepezil and other medicines. Two local Individual Case Safety Reports (ICSRs) of urinary incontinence following isotretinoin use, with a positive rechallenge in one case.

VigiBase 2026: Global Patterns, Trends, and Tools for Pharmacovigilance

April 1, 2026

This article provides a detailed medical and scientific overview of VigiBase, based on the 2026 resource profile update published by UMC researchers. It covers the database’s history, data collection and processing workflows, coding standards (WHODrug Global and MedDRA), analytical tools (including vigiMatch, vigiGrade, vigiRank, and the VigiBase pregnancy algorithm), and key descriptive statistics....

When AI Fails: Lessons from Pharmacovigilance Case Studies

March 27, 2026

Artificial intelligence (AI) is transforming pharmacovigilance. From automated case processing to signal detection and duplicate identification, AI systems promise to enhance efficiency, improve quality, and enable entirely new capabilities. However, the rapid proliferation of AI tools—coupled with decreasing development costs—creates a critical challenge: how do we know which AI systems actually work?

Drug-Induced Tuberculosis and Anti-Tuberculosis Drug Safety

March 24, 2026

World Tuberculosis Day 2026 – "Yes! We Can End TB: Led by Countries, Powered by People" From a pharmacovigilance perspective, TB presents two distinct challenges: Drug-Induced TB: Immunosuppressive medications—particularly biologics used in autoimmune diseases—can reactivate latent TB infection or predispose to new active TB. Anti-TB Drug Adverse Reactions: First-line and second-line anti-TB drugs carry significant...

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