Pharmacovigilance–The next chapter
N Moore, D Berdaï, P Blin, C Droz - Therapies, 2019 - Elsevier
The discovery and quantification of adverse drug reactions has long relied on the careful
analysis of spontaneously reported cases. Causality assessment (imputation) was a …
analysis of spontaneously reported cases. Causality assessment (imputation) was a …
Pharmacovigilance of sodium-glucose co-transporter-2 inhibitors: what a clinician should know on disproportionality analysis of spontaneous reporting systems
E Raschi, E Poluzzi, F Salvo, A Pariente… - Nutrition, Metabolism …, 2018 - Elsevier
Abstract Sodium-glucose co-transporter-2 inhibitors (SGLT2-Is) have consistently
demonstrated a clinically significant reduction of cardiovascular mortality. However, their …
demonstrated a clinically significant reduction of cardiovascular mortality. However, their …
Cardiovascular toxicity of tyrosine kinase inhibitors used in chronic myeloid leukemia: an analysis of the FDA adverse event reporting system database (FAERS)
Tyrosine kinase inhibitors (TKIs), the treatment of choice for chronic myeloid leukemia
(CML), can be associated to cardiovascular (CV) adverse events (AEs). A case/non-case …
(CML), can be associated to cardiovascular (CV) adverse events (AEs). A case/non-case …
Adverse drug reaction risks obtained from meta-analyses and pharmacovigilance disproportionality analyses are correlated in most cases
Objective We aimed at testing if a correlation between adverse drug reactions relative risks
estimated from meta-analyses and disproportionality analyses calculated from …
estimated from meta-analyses and disproportionality analyses calculated from …
Good signal detection practices: evidence from IMI PROTECT
Over a period of 5 years, the Innovative Medicines Initiative PROTECT (
Pharmacoepidemiological Research on Outcomes of Therapeutics by a European …
Pharmacoepidemiological Research on Outcomes of Therapeutics by a European …
Liver injury with novel oral anticoagulants: assessing post‐marketing reports in the US Food and Drug Administration adverse event reporting system
E Raschi, E Poluzzi, A Koci, F Salvo… - British journal of …, 2015 - Wiley Online Library
Aim We assessed the hepatic safety of novel oral anticoagulants (NOACs) analyzing the
publicly available US‐FDA adverse event reporting system (FAERS). Methods We extracted …
publicly available US‐FDA adverse event reporting system (FAERS). Methods We extracted …
Impact of the COVID-19 pandemic on the spontaneous reporting and signal detection of adverse drug events
D Montes-Grajales, R Garcia-Serna, J Mestres - Scientific Reports, 2023 - nature.com
External factors severely affecting in a short period of time the spontaneous reporting of
adverse events (AEs) can significantly impact drug safety signal detection. Coronavirus …
adverse events (AEs) can significantly impact drug safety signal detection. Coronavirus …
Analysis of factors associated with hiccups based on the Japanese Adverse Drug Event Report database
R Hosoya, Y Uesawa, R Ishii-Nozawa, H Kagaya - PLoS One, 2017 - journals.plos.org
Hiccups are occasionally experienced by most individuals. Although hiccups are not life-
threatening, they may lead to a decline in quality of life. Previous studies showed that …
threatening, they may lead to a decline in quality of life. Previous studies showed that …
Drug-induced immune hemolytic anemia: detection of new signals and risk assessment in a nationwide cohort study
J Maquet, M Lafaurie, M Michel… - Blood …, 2024 - ashpublications.org
More than 130 drugs have been suspected to induce immune hemolytic anemia.
Comparative studies measuring the risk of drug-induced immune hemolytic anemia (DIIHA) …
Comparative studies measuring the risk of drug-induced immune hemolytic anemia (DIIHA) …
Comprehensive study of the risk factors for medication-related osteonecrosis of the jaw based on the Japanese Adverse Drug Event Report Database
S Toriumi, A Kobayashi, Y Uesawa - Pharmaceuticals, 2020 - mdpi.com
Medication-related osteonecrosis of the jaw (MRONJ) is associated with many drugs,
including bisphosphonates (BPs). BPs are associated with atypical femoral fractures and …
including bisphosphonates (BPs). BPs are associated with atypical femoral fractures and …