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Pharmacovigilance

Pharmacovigilance

Post-marketing surveillance is a critical component of pharmaceutical regulation, often uncovering unanticipated adverse drug reactions (ADRs) once a drug is widely used over an extended period.
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...

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Related Experiment Video

Updated: Jan 30, 2026

The Participant-Reported Implementation Update and Score PRIUS: A Novel Method for Capturing Implementation-Related Data Over Time

The Participant-Reported Implementation Update and Score PRIUS: A Novel Method for Capturing Implementation-Related Data Over Time

Published on: February 19, 2021

[Pharmacovigilance update].

Christopher Abo Loha¹, Françoise Livio¹

¹Service de pharmacologie clinique, Département des laboratoires, CHUV, 1011 Lausanne.

Revue Medicale Suisse

|January 11, 2019

Summary

Pharmacovigilance updates in 2018 highlight new safety concerns for quinolones, denosumab, cyproterone, and ulipristal. Daclizumab was withdrawn, and risks associated with dolutegravir and drospirenone were identified.

Area of Science:

Pharmacovigilance and Drug Safety
Clinical Pharmacology
Regulatory Science

Background:

The year 2018 saw significant pharmacovigilance updates impacting various medications.
These updates reflect ongoing efforts to ensure drug safety and efficacy through post-marketing surveillance.

Purpose of the Study:

To review and summarize key pharmacovigilance findings and regulatory actions from 2018.
To inform healthcare professionals about important safety information regarding specific drug classes and individual agents.

Main Methods:

Review of reported adverse events and regulatory communications.
Analysis of safety data for drugs including quinolones, denosumab, cyproterone, Saccharomyces boulardii, ulipristal, daclizumab, antiretrovirals, and drospirenone-containing oral contraceptives.

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Main Results:

Quinolones are no longer recommended for mild infections.
Increased risks observed for denosumab (malignancies), cyproterone (meningioma), Saccharomyces boulardii (fungemia), and ulipristal (hepatotoxicity).
Daclizumab was withdrawn; specific interactions and risks with dolutegravir and drospirenone were noted.

Conclusions:

Healthcare providers must be aware of updated safety profiles for numerous medications.
Regulatory actions and revised recommendations aim to mitigate patient risks and optimize therapeutic choices.