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Published on: February 19, 2021
[Pharmacovigilance update]
Christopher Abo Loha1, Françoise Livio1
1Service de pharmacologie clinique, Département des laboratoires, CHUV, 1011 Lausanne.
Abstract:
The main pharmacovigilance updates in 2018 are reviewed. Quinolones : no longer recommended for mild or moderately severe infections. Denosumab in cancer patients: increased risk of new primary malignancies. Cyproterone : increased risk of meningioma at high dose. Saccharomyces boulardii : risk of fungemia in frail patients. Ulipristal : risk of hepatotoxicity. Daclizumab : early withdrawal from the market as risks clearly outweigh benefits. Interactions between boosted antiretrovirals and anti-P2Y12 : prasugrel appears as the best option. Neural tube defects in babies born to women treated with dolutegravir : a signal to investigate. Cobicistat-boosted antiretrovirals exposure is decreased during pregnancy. Fourth generation pills containing drospirenone : a greater propensity to prolong the QT interval than 2nd generation pills.
Insights
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 Daclizumab was withdrawn, and risks associated with dolutegravir and drospirenone were identified.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.
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- Daclizumab was withdrawn; specific interactions and risks with dolutegravir and drospirenone were noted.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.
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