Preferred Label : pharmacovigilance note;
Origin ID : TR327;
Metaterm(s)
- See also
https://ansm.sante.fr/informations-de-securite/opzelura-15-mg-g-creme-phosphate-de-ruxolitinib-information-importante-concernant-la-presence-de-particules
2025
false
false
false
France
French
pharmacovigilance note
ruxolitinib
administration, cutaneous
ruxolitinib
guideline
---
https://www.cbip.be/fr/articles/4475?folia=4464
2025
false
false
false
Belgium
French
pharmacovigilance note
journal article
Olmesartan Medoxomil
Adverse reaction caused by olmesartan (disorder)
risk
intestinal diseases
---
https://www.afmps.be/fr/news/surdosage_accidentel_avec_les_solutions_buvables_de_risperidone_1_mgml_chez_les_enfants_et
2025
false
false
false
Belgium
French
risperidone
child
adolescent
administration, oral
pharmaceutical solutions
medication errors
pharmacovigilance note
Product containing precisely risperidone 1 milligram/1 milliliter conventional release
oral solution (clinical drug)
Accidental risperidone overdose (disorder)
Drug administration error
---
https://ansm.sante.fr/informations-de-securite/specialites-contenant-du-thiocolchicoside-rappels-et-nouvelles-recommandations-concernant-le-risque-potentiel-de-genotoxicite?
2025
false
false
false
France
French
pharmacovigilance note
risk management
thiocolchicoside
Genotoxicity
administration, oral
injections, intramuscular
thiocolchicoside
Male
thiocolchicoside
---
https://ansm.sante.fr/informations-de-securite/celocurine-50-mg-ml-solution-injectable-risques-derreurs-medicamenteuses-graves-clarification-sur-le-volume-des-ampoules
2025
false
false
false
France
French
pharmacovigilance note
medication errors
suxamethonium chloride
injections, intravenous
drug labeling
suxamethonium
---
https://ansm.sante.fr/actualites/l-thyroxin-henning-levothyroxine-50-ug-et-75ug-comprime-secable-risque-de-sous-dosage-en-principe-actif-avant-leur-peremption-pour-quatre-lots
2025
false
false
false
France
French
Underdose
risk
pharmacovigilance note
---
https://www.afmps.be/fr/news/les_medicaments_de_therapie_innovante_non_reglementes_presentent_de_graves_risques_pour_la
2025
false
false
false
Belgium
French
innovative therapies
risk
patient safety
pharmacovigilance note
Dendritic Cell Therapy
immunotherapy, adoptive
dendritic cells
legislation, drug
europe
belgium
---
https://ansm.sante.fr/actualites/paracetamol-attention-aux-intoxications-volontaires-par-des-enfants-et-des-adolescents
2025
false
false
false
France
French
adolescent
acetaminophen
Intentional paracetamol poisoning (disorder)
pharmacovigilance note
child
Chemical and Drug Induced Liver Injury
liver transplantation
Chemical and Drug Induced Liver Injury
france
patient education handout
guideline
paracetamol
---
https://ansm.sante.fr/informations-de-securite/emblaveo-aztreonam-avibactam-1-5-g-0-5-g-poudre-pour-solution-a-diluer-pour-perfusion-risque-potentiel-de-flacons-fissures-ou-casses
2025
false
false
false
France
French
pharmacovigilance note
---
https://ansm.sante.fr/actualites/medicaments-a-base-de-methotrexate-par-voie-orale-imeth-novatrex-et-generiques-une-carte-patients-et-une-brochure-professionnels-de-sante-pour-eviter-les-surdosages
2025
false
false
false
France
French
risk management
risk
methotrexate
poisoning
pharmacovigilance note
guideline
patients guideline
---
https://ansm.sante.fr/informations-de-securite/entonox-170-bar-gaz-pour-inhalation-en-bouteille-risque-de-defaut-dadministration-lie-au-blocage-du-robinet-par-le-froid-lors-dune-administration-avec-un-debit-continu-superieur-a-8-l-min-branchement-a-partir-de-lolive-de-sortie-du-robinet
2025
false
false
false
France
French
pharmacovigilance note
oxygen
nitrous oxide
drug combinations
meopa
nitrous oxide, combinations
Gas Output Problem
---
https://www.cbip.be/fr/articles/4528?folia=4520
2025
false
false
false
Belgium
French
journal article
pharmacovigilance note
drug interactions
anti-inflammatory agents, non-steroidal
cholinesterase inhibitors
risk
aged
peptic ulcer
alzheimer disease
---
https://www.cbip.be/fr/articles/4495?folia=4486
2025
false
false
false
Belgium
French
journal article
pharmacovigilance note
attention deficit disorder with hyperactivity
cardiovascular diseases
risk
Long-term drug therapy (procedure)
Observational Studies as Topic
methylphenidate
central nervous system stimulants
continuity of patient care
child
adult
Lisdexamfetamine Dimesylate
Atomoxetine Hydrochloride
centrally acting sympathomimetics
---
https://ansm.sante.fr/actualites/en-cas-de-rhume-evitez-les-medicaments-vasoconstricteurs-par-voie-orale
2024
false
false
false
France
French
common cold
administration, oral
nasal decongestants
pseudoephedrine
pharmacovigilance note
patients guideline
nasopharyngitis
pseudoephedrine, combinations
myocardial infarction
stroke
Posterior reversible encephalopathy syndrome (disorder)
Reversible cerebral vasoconstriction syndrome (disorder)
---
https://ansm.sante.fr/tableau-marr/fenfluramine
2024
false
false
false
France
French
administration, oral
risk management
guidelines for drug use
pharmacovigilance note
fenfluramine
fenfluramine
continuity of patient care
drug monitoring
hypertension, pulmonary
Drug-Related side effects and adverse reactions
heart valve diseases
patients guideline
Off-Label use
---
https://ansm.sante.fr/actualites/nouvelles-donnees-en-faveur-dun-risque-accru-de-saignements-menstruels-abondants-apres-la-primovaccination-contre-le-covid-19
2024
false
false
false
France
French
pharmacovigilance note
COVID-19 Vaccines
vaccination
COVID-19
mRNA Vaccines
Administration of first dose of vaccine product containing only severe acute respiratory
syndrome coronavirus 2 messenger ribonucleic acid (procedure)
technical report
menorrhagia
covid-19, RNA-based vaccine
risk
risk assessment
---
https://ansm.sante.fr/actualites/retour-dinformation-sur-le-prac-de-janvier-2024-8-11-janvier
2024
false
false
false
France
French
risk management
valproic acid
Male
Neurodevelopmental Disorders
Chimeric antigen receptor T-cell therapy
genetic therapy
Secondary Carcinoma
Chimeric Antigen Receptor Therapy
immunotherapy, adoptive
pharmacovigilance note
---
https://ansm.sante.fr/informations-de-securite/etoposide-injectable-risque-accru-de-reactions-dhypersensibilite-lorsque-la-ligne-de-perfusion-est-equipee-dun-filtre-en-ligne
2024
false
false
false
France
French
pharmacovigilance note
---
https://ansm.sante.fr/informations-de-securite/pseudoephedrine-risques-de-syndrome-dencephalopathie-posterieure-reversible-pres-et-de-syndrome-de-vasoconstriction-cerebrale-reversible-rcvs
2024
false
false
false
France
French
pharmacovigilance note
pseudoephedrine
Posterior reversible encephalopathy syndrome (disorder)
posterior leukoencephalopathy syndrome
Reversible cerebral vasoconstriction syndrome (disorder)
cerebrovascular disorders
pseudoephedrine
administration, oral
nasal decongestants
pseudoephedrine, combinations
---
https://ansm.sante.fr/actualites/retour-dinformation-sur-le-prac-de-fevrier-2024-5-8-fevrier
2024
false
false
false
France
French
pharmacovigilance note
nirmatrelvir and ritonavir drug combination
nirmatrelvir and ritonavir drug combination
immunosuppressive agents
drug therapy, combination
drug interactions
---
https://ansm.sante.fr/informations-de-securite/paxlovid-nirmatrelvir-ritonavir-rappel-des-interactions-medicamenteuses-avec-certains-immunosuppresseurs-notamment-le-tacrolimus-pouvant-etre-fatales
2024
false
false
false
France
French
pharmacovigilance note
guidelines for drug use
drug interactions
nirmatrelvir and ritonavir drug combination
nirmatrelvir
immunosuppressive agents
tacrolimus
COVID-19 Drug Treatment
adult
nirmatrelvir and ritonavir
tacrolimus
---
Ezetrol (ezetimibe) and the Risks of Drug-Induced Liver Injury and Severe Cutaneous
Adverse Reactions
https://recalls-rappels.canada.ca/fr/avis-rappel/ezetrol-ezetimibe-et-risques-lesions-hepatiques-origine-medicamenteuse-et-reactions
2024
false
false
false
Canada
French
English
pharmacovigilance note
Ezetimibe
Chemical and Drug Induced Liver Injury
Drug-Induced Liver Disease
drug hypersensitivity syndrome
stevens-johnson syndrome
epidermal necrolysis, toxic
Drug-Induced stevens johnson syndrome
canada
administration, oral
ezetimibe
anticholesteremic agents
---
https://ansm.sante.fr/actualites/progestatifs-et-risque-de-meningiomes-intracraniens-le-bmj-publie-une-etude-epidemiologique-francaise
2024
false
false
false
France
French
pharmacovigilance note
epidemiologic studies
france
meningioma
meningioma
medroxyprogesterone acetate
risk assessment
Product containing only levonorgestrel in intrauterine dose form (medicinal product
form)
levonorgestrel
injections, intramuscular
plastic iud with progestogen
administration, intravaginal
progestins
intrauterine devices
medroxyprogesterone
---
https://ansm.sante.fr/informations-de-securite/en-cas-de-rhume-ne-pas-utiliser-de-medicaments-a-base-de-pseudoephedrine-vasoconstricteurs-par-voie-orale
2024
false
false
false
France
French
pseudoephedrine
administration, oral
pharmacovigilance note
nasal decongestants
common cold
risk factors
risk
pseudoephedrine
pseudoephedrine, combinations
guidelines
---
https://recalls-rappels.canada.ca/fr/avis-rappel/renseignements-importants-sur-innocuite-et-efficacite-albrioza-phenylbutyrate-sodium-et
2024
false
false
false
Canada
French
English
pharmacovigilance note
ursodoxicoltaurine
drug combinations
4-phenylbutyric acid, sodium salt
sodium phenylbutyrate and ursodoxicoltaurine
Safety-Based drug withdrawals
canada
multiple sclerosis
adult
---
https://www.cbip.be/fr/articles/4344?folia=4336
2024
false
false
false
Belgium
French
journal article
pharmacovigilance note
Denosumab
hypocalcemia
denosumab
renal insufficiency
---
https://ansm.sante.fr/actualites/retour-dinformation-sur-le-prac-de-juin-2024-10-13-juin
2024
false
false
false
France
French
pharmacovigilance note
risk assessment
risk
dipyrone
agranulocytosis
gene therapy
Chimeric Antigen Receptor T-cells
Antineoplastic Agents, Immunological
Therapy-Associated cancer
Chimeric Antigen Receptor Therapy
---
https://www.cbip.be/fr/articles/4345?folia=4336
2024
false
false
false
Belgium
French
pharmacovigilance note
journal article
mianserin
mianserin
Compulsive Sexual Behavior Disorder
antidepressive agents, second-generation
aged
---
https://ansm.sante.fr/actualites/analogues-du-glp-1-point-sur-la-surveillance-des-effets-indesirables-graves-et-mesusages
2024
false
false
false
France
French
pharmacovigilance note
Glucagon-Like Peptide-1 Receptor Agonists
Serious Adverse Drug Reaction
product surveillance, postmarketing
pharmacovigilance
Drug Misuse
---
https://ansm.sante.fr/actualites/essai-clinique-ribolaris-dans-le-cancer-du-sein-precoce-suspension-partielle-et-modification-des-modalites-de-realisation-de-lessai-clinique
2024
false
false
false
France
French
drugs, investigational
Clinical Trial Suspension
breast neoplasms
drug impurity
nitrosamines
ribociclib
pharmacovigilance note
---
https://ansm.sante.fr/actualites/retour-dinformation-sur-le-prac-de-juillet-2024-8-11-juillet
2024
false
false
false
France
French
pharmacovigilance note
europe
Glatiramer Acetate
Glucagon-Like Peptide-1 Receptor Agonists
risk management
anesthesia, general
deep sedation
Aspiration Pneumonitis
anaphylaxis
---
https://ansm.sante.fr/informations-de-securite/abecma-breyanzi-carvykti-kymriah-tecartus-et-yescarta-therapies-cellulaires-car-t-dirigees-contre-les-antigenes-cd19-ou-bcma-risque-de-tumeur-maligne-secondaire-issue-de-lymphocytes-t
2024
false
false
false
France
French
pharmacovigilance note
Secondary Malignant Neoplasm
Anti-CD19 CAR T Cells Preparation
Anti-BCMA CAR T Cells Preparation
Chimeric Antigen Receptor Therapy
lymphoma, T-Cell
continuity of patient care
hematologic neoplasms
leukemia, t-cell
Antineoplastic cell and gene therapy
---
https://ansm.sante.fr/informations-de-securite/acetate-de-glatiramere-des-reactions-anaphylactiques-peuvent-survenir-des-mois-voire-des-annees-apres-linstauration-du-traitement
2024
false
false
false
France
French
pharmacovigilance note
Glatiramer Acetate
glatiramer acetate
adjuvants, immunologic
anaphylaxis
Anaphylactic Reaction
injections, subcutaneous
multiple sclerosis, relapsing-remitting
---
https://ansm.sante.fr/actualites/lautorisation-de-mise-sur-le-marche-du-medicament-progesterone-retard-pharlon-caproate-dhydroxyprogesterone-est-suspendue
2024
false
false
false
France
French
pharmacovigilance note
Safety-Based drug withdrawals
17 alpha-Hydroxyprogesterone Caproate
injections, intramuscular
Delayed-Action preparations
progestins
hydroxyprogesterone
neoplasms
prenatal exposure delayed effects
In Utero Drug Exposure
---
https://ansm.sante.fr/informations-de-securite/suspension-des-autorisations-de-mise-sur-le-marche-des-medicaments-contenant-du-caproate-dhydroxyprogesterone
2024
false
false
false
France
French
pharmacovigilance note
Safety-Based drug withdrawals
17 alpha-Hydroxyprogesterone Caproate
injections, intramuscular
Delayed-Action preparations
progestins
hydroxyprogesterone
neoplasms
prenatal exposure delayed effects
In Utero Drug Exposure
guideline
---
https://ansm.sante.fr/informations-de-securite/crayon-au-nitrate-dargent-restriction-des-indications-et-rappel-des-risques
2024
false
false
false
France
French
guidelines for drug use
pharmacovigilance note
silver nitrate
silver nitrate
risk
---
https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/medeffet-canada/infovigilance-produits-sante/aout-2024.html#a2_a1
2024
false
false
false
Canada
French
pregnancy
Pregnant People
pharmacovigilance note
calcium carbonate
antacids
Milk-Alkali syndrome
risk
gastroesophageal reflux
calcium carbonate
---
https://ansm.sante.fr/actualites/defaut-qualite-de-certains-flacons-damoxicilline-acide-clavulanique-100-mg-12-5-mg-par-ml-suspension-buvable
2024
false
false
false
France
French
pharmacovigilance note
---
https://ansm.sante.fr/informations-de-securite/caspofungine-lansm-recommande-de-ne-pas-utiliser-de-membrane-derivee-du-polyacrylonitrile-chez-les-patients-en-soins-intensifs-sous-hemofiltration
2024
false
false
false
France
French
pharmacovigilance note
guidelines for drug use
Caspofungin
risk management
intensive care
hemofiltration
Lack of drug action (finding)
Hemofiltration system (physical object)
physicochemical incompatibility
polyacrylonitrile
---
https://ansm.sante.fr/actualites/analogues-du-glp-1-et-obesite-nous-prenons-des-mesures-pour-securiser-leur-utilisation-en-france
2024
false
false
false
France
French
patient safety
Glucagon-Like Peptide-1 Receptor Agonists
obesity
france
Drug Misuse
prescription drug misuse
drug prescriptions
critical pathways
semaglutide
Wegovy
pharmacovigilance note
guideline
Saxenda
---
https://ansm.sante.fr/informations-de-securite/oxbryta-voxelotor-suspension-de-lautorisation-de-mise-sur-le-marche-de-lunion-europeenne
https://ansm.sante.fr/actualites/oxbryta-voxelotor-conduite-a-tenir-suite-a-la-suspension-de-lautorisation-de-mise-sur-le-marche
2024
false
false
false
France
French
Safety-Based drug withdrawals
voxelotor
pharmacovigilance note
voxelotor
guidelines for drug use
drugs, investigational
france
europe
hematologic agents
Vaso-Occlusive Crisis
---
https://www.cbip.be/fr/articles/4448?folia=4434
2024
false
false
false
Belgium
French
pharmacovigilance note
journal article
cyclosporine
risk
fibroadenoma
premenopause
---
https://ansm.sante.fr/actualites/therapie-illegale-dans-le-traitement-du-cancer-nous-prenons-des-decisions-de-police-sanitaire-a-lencontre-de-trois-societes-promouvant-des-therapies-cellulaires-dendritiques-non-autorisees-en-france
2024
false
false
false
France
French
legislation, pharmacy
drug information
pharmacovigilance note
Dendritic Cell Therapy
france
neoplasms
---
https://www.cbip.be/fr/articles/4461?folia=4453
2024
false
false
false
Belgium
French
pharmacovigilance note
journal article
Selective Serotonin Reuptake Inhibitors
anticoagulants
drug interactions
administration, oral
antivitamins K
Direct Oral Anticoagulant
---
https://ansm.sante.fr/informations-de-securite/alofisel-darvadstrocel-retrait-du-marche-de-lunion-europeenne-en-raison-de-labsence-de-demonstration-dun-benefice-clinique-suffisant-justifiant-le-maintien-de-son-utilisation
2024
false
false
false
France
French
Safety-Based drug withdrawals
pharmacovigilance note
Darvadstrocel
europe
risk assessment
mesenchymal stem cell transplantation
---
https://ansm.sante.fr/informations-de-securite/adagrasib-risque-potentiel-deffets-indesirables-cutanes-severes
2024
false
false
false
France
French
pharmacovigilance note
risk
adagrasib
stevens-johnson syndrome
epidermal necrolysis, toxic
adagrasib
antineoplastic agents
Adagrasib Regimen
---
https://ansm.sante.fr/informations-de-securite/valproate-et-derives-risque-potentiel-de-troubles-neurodeveloppementaux-chez-les-enfants-dont-le-pere-a-ete-traite-dans-les-3-mois-qui-precedent-la-conception
2023
false
false
false
France
French
pharmacovigilance note
Divalproex Sodium
Neurodevelopmental Disorders
Male
risk
risk assessment
fathers
infant
child
Perinatal Exposure
paternal exposure
valproic acid
valproate sodium
teratogens
---
https://www.ansm.sante.fr/actualites/anti-inflammatoires-non-steroidiens-ains-et-complications-infectieuses-graves
2023
false
false
false
France
French
pharmacovigilance note
anti-inflammatory agents, non-steroidal
Infections
fever
pain
ibuprofen
ketoprofen
adult
child
streptococcal infections
guidelines for drug use
---
https://ansm.sante.fr/informations-de-securite/ketamine-une-utilisation-prolongee-entraine-des-atteintes-graves-hepatiques-et-uronephrologiques
2023
false
false
false
France
French
pharmacovigilance note
ketamine
kidney diseases
Drug-Induced Liver Disease
cystitis
narcotics
prescription drug misuse
guidelines for drug use
Long-Term
Off-Label use
biliary tract diseases
---
Domperidone and psychiatric withdrawal events when used off-label for lactation stimulation
https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/medeffet-canada/infovigilance-produits-sante/aout-2023.html#a3-1-1
2023
false
false
false
Canada
French
English
pharmacovigilance note
domperidone
Off-Label use
substance withdrawal syndrome
Lactation stimulation therapy
---
https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/medeffet-canada/infovigilance-produits-sante/aout-2023.html#a3-1-2
2023
false
false
false
Canada
French
pharmacovigilance note
Medicinal product acting as mineral supplement (product)
mineral supplements
medication errors
---
https://ansm.sante.fr/actualites/topiramate-epitomax-et-generiques-et-troubles-neurodeveloppementaux-mise-en-place-de-mesures-en-europe-pour-limiter-lutilisation-pendant-la-grossesse
2023
false
false
false
France
French
pharmacovigilance note
guidelines for drug use
Topiramate
pregnancy
europe
Neurodevelopmental Disorders
risk
risk management
drug evaluation
Topiramate
france
anticonvulsants
anticonvulsants
anticonvulsants
Topiramate
topiramate
Female of Childbearing Potential
---
https://ansm.sante.fr/informations-de-securite/lamotrigine-lamictal-et-generiques-rappel-du-bon-usage-afin-de-limiter-le-risque-deruption-cutanee-grave-en-particulier-au-debut-du-traitement
2023
false
false
false
France
French
pharmacovigilance note
guidelines for drug use
Lamotrigine
Lamotrigine
risk management
lamotrigine
anticonvulsants
anticonvulsants
stevens-johnson syndrome
drug eruptions
Drug-Related side effects and adverse reactions
epidermal necrolysis, toxic
drug hypersensitivity syndrome
adult
child
drug interactions
---
https://ansm.sante.fr/informations-de-securite/medicaments-a-base-de-mianserine-rappel-du-bon-usage-et-des-risques-deffets-indesirables-graves-notamment-chez-les-patients-ages
2023
false
false
false
France
French
mianserin
aged
risk
mianserin
pharmacovigilance note
guidelines for drug use
Off-Label use
sleep initiation and maintenance disorders
depressive disorder, major
antidepressive agents, second-generation
---
https://ansm.sante.fr/informations-de-securite/simponi-golimumab-50-mg-et-100-mg-modifications-importantes-des-instructions-dutilisation-du-stylo-prerempli-smartject
2023
false
false
false
France
French
guidelines for drug use
golimumab
pharmacovigilance note
Pre-filled Pen Syringe
injections, subcutaneous
Device malfunction
---
https://www.cbip.be/fr/articles/4168?folia=4158
2023
false
false
false
Belgium
French
pharmacovigilance note
journal article
clomiphene
selective estrogen receptor modulators
vision disorders
Clomiphene adverse reaction (disorder)
clomiphene
---
Summary Safety Review - Keytruda (pembrolizumab) and Tecentriq (atezolizumab) - Assessing
the Potential Risk of Aplastic Anemia
https://pmps.hpfb-dgpsa.ca/documents-d-examen/ressource/SSR1691503886633
2023
false
false
false
Canada
French
drug evaluation
Drug-Related side effects and adverse reactions
pembrolizumab
antibodies, monoclonal, humanized
atezolizumab
Antineoplastic Agents, Immunological
risk assessment
anemia, aplastic
Immune Checkpoint Inhibitors
canada
pharmacovigilance note
---
https://ansm.sante.fr/actualites/encore-trop-de-grossesses-sous-carbamazepine-nous-souhaitons-renforcer-linformation-pour-limiter-lexposition
2023
false
false
false
France
French
pharmacovigilance note
pregnancy
carbamazepine
teratogens
abnormalities, drug-induced
guidelines for drug use
---
https://ansm.sante.fr/actualites/retour-dinformation-sur-le-prac-doctobre-2023-25-28-septembre
2023
false
false
false
France
French
pharmacovigilance note
product surveillance, postmarketing
Omacor
omega-3-triglycerides incl. other esters and acids
atrial fibrillation
omega-3 ethyl ester 90
---
https://ansm.sante.fr/informations-de-securite/lema-alerte-sur-la-circulation-de-stylos-ozempic-falsifies-semaglutide-1mg-solution-injectable-en-europe
2023
false
false
false
France
French
pharmacovigilance note
counterfeit drugs
europe
Falsified Drugs
guideline
semaglutide
---
https://www.cbip.be/fr/articles/4188?folia=4179
2023
false
false
false
Belgium
French
journal article
pharmacovigilance note
migraine disorders
Drug-Related side effects and adverse reactions
alopecia
Medicinal product acting as antimigraine agent (product)
Calcitonin gene-related peptide (CGRP) antagonists
calcitonin gene-related peptide
Calcitonin Gene-Related Peptide Receptor Antagonists
---
https://ansm.sante.fr/informations-de-securite/ferrostrane-0-68-pour-cent-sirop-feredetate-de-sodium-risque-derreur-medicamenteuse-chez-les-nourrissons-de-faible-poids
2023
false
false
false
France
French
pharmacovigilance note
ferric sodium edetate
infant
infant, low birth weight
medication errors
---
https://ansm.sante.fr/informations-de-securite/esters-ethyliques-dacides-omega-3-risque-accru-et-dose-dependant-de-fibrillation-auriculaire-ou-atriale-chez-des-patients-atteints-de-maladies-cardiovasculaires-ou-presentant-des-facteurs-de-risque-cardiovasculaires
2023
false
false
false
France
French
pharmacovigilance note
risk
Dose-dependent
atrial fibrillation
risk factors
fatty acids, Omega-3
Omega-3-Acid Ethyl Esters
---
https://ansm.sante.fr/actualites/chlorhexidine-attention-au-risque-de-reaction-allergique-immediate-grave
2023
false
false
false
France
French
chlorhexidine
anti-infective agents, local
hypersensitivity, immediate
drug hypersensitivity
pharmacovigilance note
---
https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/medeffet-canada/infovigilance-produits-sante/novembre-2023.html#a3.2.1
2023
false
false
false
Canada
French
pharmacovigilance note
canada
---
https://ansm.sante.fr/actualites/risque-dallergie-grave-aux-curares-en-cas-dutilisation-des-sirops-contre-la-toux-contenant-de-la-pholcodine
2023
false
false
false
France
French
pharmacovigilance note
antitussive agents
pholcodine
drug hypersensitivity
Safety-Based drug withdrawals
cross reactions
neuromuscular blocking agents
pholcodine
pholcodine
---
https://ansm.sante.fr/actualites/suspension-des-autorisations-de-mise-sur-le-marche-de-deux-medicaments-apres-decision-de-la-commission-europeenne
2023
false
false
false
France
French
pharmacovigilance note
---
https://www.cbip.be/fr/articles/3988?folia=3979
2023
false
false
false
Belgium
French
pharmacovigilance note
ophthalmic solutions
administration, ophthalmic
risk
prostaglandins, synthetic
pregnancy
abortion, spontaneous
risk assessment
---
https://www.cbip.be/fr/articles/3994?folia=3979
2023
false
false
false
Belgium
French
pharmacovigilance note
journal article
stroke
domperidone
metoclopramide
antiemetics
metopimazine
risk assessment
---
https://www.cbip.be/fr/articles/4012?folia=4002
2023
false
false
false
Belgium
French
journal article
pharmacovigilance note
medication errors
---
https://ansm.sante.fr/informations-de-securite/codeine-ibuprofene-antarene-codeine-risque-datteintes-renales-gastro-intestinales-et-metaboliques-graves-devolution-parfois-fatale-en-cas-dabus-et-de-dependance-a-lantarene-codeine
https://ansm.sante.fr/actualites/antarene-codeine-codeine-ibuprofene-la-prise-prolongee-en-cas-dabus-et-de-dependance-peut-entrainer-une-toxicite-renale-et-intestinale-pouvant-conduire-au-deces
2023
false
false
false
France
French
pharmacovigilance note
drug combinations
codeine
ibuprofen
codeine and ibuprofen
administration, oral
codeine
opioid-related disorders
intestinal perforation
gastrointestinal hemorrhage
ibuprofen
renal insufficiency
hypokalemia
acidosis, renal tubular
anti-inflammatory agents, non-steroidal
analgesics, opioid
---
https://ansm.sante.fr/actualites/les-sterilets-contenant-le-plus-dhormone-presenteraient-davantage-de-risque-de-troubles-depressifs
2023
false
false
false
France
French
pharmacovigilance note
---
https://ansm.sante.fr/informations-de-securite/zolgensma-onasemnogene-abeparvovec-cas-dinsuffisance-hepatique-aigue-dissue-fatale
2023
false
false
false
France
French
pharmacovigilance note
risk
onasemnogene abeparvovec-xioi
Onasemnogene Abeparvovec
onasemnogene abeparvovec
liver function tests
continuity of patient care
Monitoring of liver function (regime/therapy)
liver failure, acute
child
infant
liver failure, acute
guidelines for drug use
---
https://ansm.sante.fr/actualites/ozempic-semaglutide-un-medicament-a-utiliser-uniquement-dans-le-traitement-du-diabete-de-type-2
2023
false
false
false
France
French
Off-Label use
semaglutide
injections, subcutaneous
hypoglycemic agents
weight loss
drug overdose
pharmacovigilance note
guideline
guidelines for drug use
diabetes mellitus, type 2
Glucagon-Like Peptide-1 Receptor
Prescription Drug Monitoring Programs
---
https://ansm.sante.fr/informations-de-securite/clariscan-0-5-mmol-ml-solution-injectable-en-seringue-pre-remplie-15-et-20-ml-precaution-pour-limiter-le-risque-de-mouvement-du-piston-lors-de-linjection
2023
false
false
false
France
French
guidelines for drug use
pharmacovigilance note
injections, intravenous
contrast media
gadoterate meglumine
Syringe issue
---
https://ansm.sante.fr/informations-de-securite/rupture-de-stock-darsenic-trioxide-accord-1mg-ml-attention-au-risque-derreur-medicamenteuse-en-cas-de-remplacement-par-trisenox-2mg-ml
2023
false
false
false
France
French
pharmacovigilance note
---
https://ansm.sante.fr/informations-de-securite/kits-optiject-risque-de-fissure-au-niveau-de-la-connexion-entre-la-seringue-et-la-tubulure-dinjection-de-produit-de-contraste
2023
false
false
false
France
French
pharmacovigilance note
contrast media
risk
Device cracked
ioversol
ioversol
---
https://ansm.sante.fr/actualites/les-enfants-exposes-a-lhydroxychloroquine-pendant-la-grossesse-de-leur-mere-courent-un-risque-plus-eleve-de-malformation-grave-a-la-naissance
2023
false
false
false
France
French
abnormalities, drug-induced
teratogens
pharmacovigilance note
pregnancy
hydroxychloroquine
risk
patient education handout
In Utero Drug Exposure
antirheumatic agents
---
https://ansm.sante.fr/informations-de-securite/inhibiteurs-de-janus-kinase-et-traitement-des-maladies-inflammatoires-chroniques-restrictions-dutilisation-pour-diminuer-le-risque-deffets-indesirables-graves
https://ansm.sante.fr/actualites/inhibiteurs-de-janus-kinase-et-traitement-des-maladies-inflammatoires-chroniques-restrictions-dutilisation-pour-diminuer-le-risque-deffets-indesirables-graves
2023
false
false
false
France
French
pharmacovigilance note
guidelines for drug use
Janus Kinase Inhibitors
Chronic inflammatory disorder (disorder)
chronic disease
---
https://ansm.sante.fr/informations-de-securite/neofordex-40-mg-dexamethasone-suppression-de-la-barre-de-secabilite-et-de-la-posologie-associee-de-20-mg
https://ansm.sante.fr/actualites/neofordex-40-mg-dexamethasone-attention-au-risque-derreur-medicamenteuse-avec-le-nouveau-comprime-sans-barre-de-secabilite
2023
false
false
false
France
French
drug information
dexamethasone
dexamethasone acetate
dexamethasone
administration, oral
medication errors
pharmacovigilance note
---
https://ansm.sante.fr/informations-de-securite/gencebok-10-mg-ml-solution-pour-perfusion-citrate-de-cafeine-attention-au-risque-derreur-medicamenteuse
2023
false
false
false
France
French
pharmacovigilance note
caffeine
caffeine
infusions, intravenous
infant, premature
caffeine citrate
infant, premature, diseases
apnea
central nervous system stimulants
Apnea of Prematurity
medication errors
guidelines for drug use
---
https://ansm.sante.fr/informations-de-securite/simulect-10-mg-et-simulect-20-mg-poudre-et-solvant-pour-solution-injectable-ou-pour-perfusion-ne-pas-utiliser-les-ampoules-de-solvant-eau-pour-preparations-injectables-eau-ppi-conditionnees-avec-les-flacons
2023
false
false
false
France
French
pharmacovigilance note
---
https://www.cbip.be/fr/articles/4075?folia=4050
2023
false
false
false
Belgium
French
journal article
administration, oral
ivermectin
ivermectin
antiparasitic agents
drug eruptions
epidermal necrolysis, toxic
stevens-johnson syndrome
pharmacovigilance note
---
https://ansm.sante.fr/informations-de-securite/attention-au-risque-derreur-medicamenteuse-de-surdose-accidentelle-avec-la-nouvelle-pipette-de-theralene
2023
false
false
false
France
French
medication errors
pharmacovigilance note
trimeprazine
pharmaceutical solutions
administration, oral
---
https://ansm.sante.fr/informations-de-securite/prodilantin-fosphenytoine-sodique-ne-doit-pas-etre-utilise-chez-lenfant-de-moins-de-5-ans
2023
false
false
false
France
French
child
infant
fosphenytoin sodium
pharmacovigilance note
fosphenytoin
emergency treatment
epilepsy, tonic-clonic
seizures
---
https://ansm.sante.fr/actualites/acidose-lactique-et-metformine-un-risque-evitable
2023
false
false
false
France
French
risk management
metformin
acidosis, lactic
Drug-Related side effects and adverse reactions
acidosis, lactic
pharmacovigilance note
guidelines for drug use
patients guideline
renal insufficiency
risk factors
continuity of patient care
hypoglycemic agents
Renal function monitoring (regime/therapy)
---
https://ansm.sante.fr/informations-de-securite/fluoroquinolones-a-ne-prescrire-que-pour-des-infections-severes
2023
false
false
false
France
French
pharmacovigilance note
---
https://ansm.sante.fr/informations-de-securite/gavreto-pralsetinib-augmentation-du-risque-de-tuberculose-et-mesures-de-reduction-du-risque-associees
2023
false
false
false
France
French
pharmacovigilance note
risk
tuberculosis
pralsetinib
pralsetinib
---
https://ansm.sante.fr/actualites/progestatifs-et-meningiome-pas-daugmentation-du-risque-avec-les-diu-au-levonorgestrel-mais-confirmation-du-risque-pour-3-nouvelles-substances
2023
false
false
false
France
French
technical report
pharmacovigilance note
meningioma
risk assessment
meningioma
intrauterine devices, medicated
levonorgestrel
progestins
promegestone
medrogestone
administration, oral
medroxyprogesterone acetate
injections, intramuscular
administration, intravaginal
retrospective studies
---
https://ansm.sante.fr/informations-de-securite/clomid-50-mg-comprime-risque-de-troubles-visuels-graves-cecite
2023
false
false
false
France
French
blindness
pharmacovigilance note
risk
clomiphene
vision disorders
clomiphene citrate
clomifene
optic neuritis
optic neuropathy, ischemic
retinal vein occlusion
Central Retinal Vein Occlusion
retinal detachment
vitreous detachment
---
https://ansm.sante.fr/actualites/clomid-citrate-de-clomifene-le-traitement-doit-etre-arrete-en-cas-dalteration-de-la-vision
2023
false
false
false
France
French
guidelines for drug use
clomiphene
vision disorders
pharmacovigilance note
clomiphene citrate
fertility agents, female
clomifene
---
https://ansm.sante.fr/actualites/lamotrigine-attention-au-risque-deruption-cutanee-grave-en-particulier-au-debut-du-traitement
2023
false
false
false
France
French
pharmacovigilance note
Lamotrigine
lamotrigine
drug eruptions
administration, oral
anticonvulsants
antipsychotic agents
drug hypersensitivity syndrome
epidermal necrolysis, toxic
Drug-Induced stevens johnson syndrome
guidelines for drug use
---
https://ansm.sante.fr/informations-de-securite/bricanyl-turbuhaler-et-bricanyl-nebuliseur-information-importante-a-transmettre-aux-patients
2023
false
false
false
France
French
guidelines for drug use
-
terbutaline
administration, inhalation
bronchodilator agents
adrenergic beta-2 receptor agonists
terbutaline
pharmacovigilance note
---
https://ansm.sante.fr/tableau-marr/citrate-de-cafeine
2023
false
false
false
France
French
pharmacovigilance note
caffeine citrate
guidelines for drug use
infant, newborn
infusions, intravenous
infant, premature
caffeine citrate
sleep apnea, newborn, primary
Primary apnea in the newborn (finding)
sleep apnea, central
caffeine
citrates
caffeine
citrates
---
https://ansm.sante.fr/tableau-marr/chlorhydrate-de-mexiletine
2023
false
false
false
France
French
pharmacovigilance note
mexiletine hydrochloride
guidelines for drug use
risk management
mexiletine hydrochloride
arrhythmias, cardiac
hepatic insufficiency
mexiletine hydrochloride
patient education handout
Drug-Related side effects and adverse reactions
risk
continuity of patient care
mexiletine
mexiletine
mexiletine
---
https://ansm.sante.fr/tableau-marr/atidarsagene-autotemcel
2023
false
false
false
France
French
guidelines for drug use
pharmacovigilance note
Atidarsagene Autotemcel
risk management
infusions, intravenous
gene therapy
atidarsagene autotemcel
biological products
---
https://ansm.sante.fr/informations-de-securite/antibiotiques-de-la-famille-des-fluoroquinolones-administres-par-voie-systemique-ou-inhalee-rappel-des-restrictions-dutilisation
2023
false
false
false
France
French
guidelines for drug use
pharmacovigilance note
fluoroquinolones
administration, oral
administration, inhalation
injections
Off-Label use
---
https://ansm.sante.fr/dossiers-thematiques/lutenyl-luteran
2022
false
true
false
France
French
progesterone congeners
chlormadinone acetate
nomegestrol acetate
nomegestrol
chlormadinone
guidelines for drug use
pharmacovigilance note
meningioma
continuity of patient care
meningioma
risk
risk management
risk assessment
mass screening
meningioma
---
https://ansm.sante.fr/informations-de-securite/irinotecan-cancer-colorectal-reduire-la-dose-initiale-chez-les-patients-metaboliseurs-lents-de-lugt1a1-qui-doivent-recevoir-une-dose-dirinotecan-180-mg-m2-ou-qui-ont-une-sante-particulierement-fragile-quelle-que-soit-la-dose
2022
false
false
false
France
French
pharmacovigilance note
Irinotecan
Uridine diphosphate glucuronosyltransferase family 1 member A1 poor metabolizer (finding)
UGT1A1 enzyme
antineoplastic agents
risk management
diarrhea
neutropenia
topoisomerase I inhibitors
Irinotecan
topoisomerase I inhibitors
antineoplastic agents
colorectal neoplasms
UGT1A1*28 Allele
UGT1A1*6 Allele
Irinotecan
---
https://ansm.sante.fr/tableau-marr/paracetamol
2022
false
false
false
France
French
acetaminophen
infusions, intravenous
medication errors
pharmacovigilance note
guidelines for drug use
child
infant, newborn
infant
paracetamol
---
https://ansm.sante.fr/informations-de-securite/citalopram-et-escitalopram-seropram-seroplex-generiques-rappel-sur-le-risque-dallongement-dose-dependant-de-lintervalle-qt
2022
false
false
false
France
French
guidelines for drug use
citalopram
citalopram
Escitalopram
Escitalopram
Selective Serotonin Reuptake Inhibitors
Selective Serotonin Reuptake Inhibitors
long qt syndrome
adult
aged
escitalopram
citalopram
pharmacovigilance note
---
https://ansm.sante.fr/informations-de-securite/rucaparib-rubraca-recommandation-temporaire-de-ne-pas-initier-de-traitement-en-troisieme-ligne-therapeutique-compte-tenu-de-la-diminution-de-la-survie-globale-par-rapport-au-traitement-de-reference-analyse-intermediaire-de-letude-co-338-043-ariel4
2022
false
false
false
France
French
pharmacovigilance note
survival
rucaparib
Carcinoma, Ovarian Epithelial
fallopian tube neoplasms
peritoneal neoplasms
risk assessment
Poly(ADP-ribose) Polymerase Inhibitors
rucaparib
guidelines
---
https://ansm.sante.fr/informations-de-securite/reactions-cutanees-graves-et-cytolyse-hepatique-avec-etifoxine-gelules-50-mg-stresam-et-generiques-nouvelles-contre-indications-mises-en-garde-et-precautions-demploi
2022
false
false
false
France
French
etifoxine
pharmacovigilance note
administration, oral
drug eruptions
Hepatic cytolysis
Chemical and Drug Induced Liver Injury
etifoxine
etifoxine
---
https://ansm.sante.fr/informations-de-securite/ocalivav-acide-obeticholique-nouvelle-contre-indication-pour-le-traitement-de-la-cholangite-biliaire-primitive-cbp-chez-les-patients-presentant-une-cirrhose-hepatique-decompensee-ou-des-antecedents-de-decompensation-hepatique
2022
false
false
false
France
French
pharmacovigilance note
Primary Biliary Cholangitis
obeticholic acid
Hepatic decompensation
obeticholic acid
guidelines for drug use
---
https://ansm.sante.fr/informations-de-securite/defitelio-defibrotide-v-a-ne-pas-utiliser-en-prophylaxie-de-la-maladie-veino-occlusive-mvo-apres-une-transplantation-de-cellules-souches-hematopoietiques-tcsh
2022
false
false
false
France
French
hematopoietic stem cell transplantation
pharmacovigilance note
defibrotide
infusions, intravenous
defibrotide
survival
hepatic veno-occlusive disease
treatment outcome
medical futility
---
https://ansm.sante.fr/informations-de-securite/dexmedetomidine-risque-accru-de-mortalite-chez-les-patients-jusqua-65-ans-en-unites-de-soins-intensifs-usi
2022
false
false
false
France
French
aged
pharmacovigilance note
risk
mortality
dexmedetomidine
hypnotics and sedatives
dexmedetomidine
infusions, intravenous
risk assessment
---
https://ansm.sante.fr/actualites/candidose-mammaire-et-allaitement-eviter-le-violet-de-gentiane
2022
false
false
false
France
French
breast feeding
gentian violet
pharmacovigilance note
infant, newborn
patients guideline
guidelines for drug use
breast diseases
candidiasis, cutaneous
---
https://ansm.sante.fr/actualites/topiramate-pregabaline-et-valproate-publication-de-nouvelles-donnees-sur-les-risques-lies-a-lexposition-a-ces-medicaments
2022
false
false
false
France
French
pharmacovigilance note
pregnancy
Topiramate
Pregabalin
valproic acid
abnormalities, drug-induced
fertility
anticonvulsants
Neurodevelopmental Disorders
Exposure during pregnancy
---
https://ansm.sante.fr/actualites/topiramate-risque-de-troubles-neurodeveloppementaux-chez-les-enfants-exposes-in-utero-et-rappel-des-regles-dutilisation-chez-les-femmes
2022
false
false
false
France
French
Neurodevelopmental Disorders
pregnancy
pharmacovigilance note
Topiramate
Exposure during pregnancy
anticonvulsants
topiramate
guidelines for drug use
risk
risk management
child
Autism Spectrum Disorder
intellectual disability
---
https://ansm.sante.fr/actualites/le-risque-de-malformation-chez-les-enfants-exposes-pendant-la-grossesse-a-la-pregabaline-est-confirme
2022
false
false
false
France
French
pharmacovigilance note
abnormalities, drug-induced
Pregabalin
anticonvulsants
pregnancy
teratogens
pregabalin
---
https://ansm.sante.fr/actualites/valproate-et-derives-mise-a-jour-des-informations-sur-le-risque
2022
false
false
false
France
French
valproic acid
risk
pharmacovigilance note
valproic acid
pregnancy
abnormalities, drug-induced
eye abnormalities
risk assessment
dipropylacetamide
anticonvulsants
valproic acid
valpromide
valproate sodium
Divalproex Sodium
---
https://ansm.sante.fr/informations-de-securite/intoxications-graves-a-la-colchicine-colchicine-opocalcium-1-mg-et-colchimax-rappel-des-regles-de-bon-usage
2022
false
false
false
France
French
colchicine
administration, oral
pharmacovigilance note
guidelines for drug use
colchicine
gout suppressants
drug combinations
aged
---
https://ansm.sante.fr/actualites/cancer-de-la-vessie-des-mesures-pour-reduire-le-risque-de-graves-reactions-cutanees-associe-a-lenfortumab-vedotin-autorise-en-acces-precoce
2022
false
false
false
France
French
urinary bladder neoplasms
enfortumab vedotin
Metastatic Bladder Urothelial Carcinoma
Locally Advanced Bladder Urothelial Carcinoma
patients guideline
continuity of patient care
drug eruptions
stevens-johnson syndrome
epidermal necrolysis, toxic
pharmacovigilance note
drug monitoring
enfortumab vedotin
---
https://ansm.sante.fr/actualites/medicaments-a-base-de-methotrexate-par-voie-orale-imeth-novatrex-et-generiques-une-carte-patients-et-une-brochure-professionnels-de-sante-pour-eviter-les-surdosages
2022
false
false
false
France
French
methotrexate
administration, oral
Methotrexate overdose (disorder)
drug overdose
pharmacovigilance note
patients guideline
guideline
drug interactions
risk management
methotrexate
---
https://ansm.sante.fr/informations-de-securite/cancer-epithelial-de-lovaire-des-trompes-et-du-peritoine-primitif-rucaparib-rubraca-ne-doit-plus-etre-utilise-en-3-ligne
2022
false
false
false
France
French
pharmacovigilance note
guidelines for drug use
survival analysis
rucaparib
rucaparib
treatment outcome
ovarian neoplasms
fallopian tube neoplasms
peritoneal neoplasms
Maintenance Therapy
---
https://www.cbip.be/fr/articles/3870?folia=3863
2022
false
false
false
Belgium
French
pholcodine
drug interactions
pharmacovigilance note
neuromuscular blocking agents
antitussive agents
drug overdose
pholcodine
---
https://ansm.sante.fr/informations-de-securite/pediaven-ap-hp-attention-aux-erreurs-de-reconstitution-avant-perfusion
2022
false
false
false
France
French
medication errors
pharmacovigilance note
Product preparation error
guidelines for drug use
infusions, intravenous
electrolytes
amino acids
glucose
parenteral nutrition solutions
combinations
infant
child
---
IMBRUVICA (ibrutinib) - Risk of Serious and Fatal Cardiac Arrhythmias or Cardiac Failure
https://recalls-rappels.canada.ca/fr/avis-rappel/imbruvica-ibrutinib-risque-arythmies-cardiaques-ou-insuffisance-cardiaque-graves-et
2022
false
false
false
Canada
French
English
arrhythmias, cardiac
heart failure
ibrutinib
ibrutinib
administration, oral
protein kinase inhibitors
antineoplastic agents
pharmacovigilance note
guidelines for drug use
continuity of patient care
---
https://recalls-rappels.canada.ca/fr/avis-rappel/zolgensma-onasemnogene-abeparvovec-et-cas-mortels-insuffisance-hepatique-aigue
2022
false
false
false
Canada
French
English
pharmacovigilance note
liver failure, acute
onasemnogene abeparvovec-xioi
guidelines for drug use
onasemnogene abeparvovec
drug monitoring
continuity of patient care
liver function tests
glucocorticoids
Chemical and Drug Induced Liver Injury
5q spinal muscular atrophy
spinal muscular atrophies of childhood
---
https://ansm.sante.fr/informations-de-securite/cyclophosphamide-reddy-pharma-500mg-1ml-1000mg-2ml-et-2000mg-4ml-solutions-a-diluer-pour-solution-injectable-pour-perfusion-cyclophosphamide-contre-indication-chez-les-enfants-et-les-adolescents-en-raison-de-la-teneur-en-alcool
2022
false
false
false
France
French
pharmacovigilance note
child
adolescent
infusions, intravenous
ethanol
cyclophosphamide
pharmaceutical solutions
---
https://ansm.sante.fr/informations-de-securite/specialites-a-base-dhydroxyethylamidon-hea-v-suspension-des-autorisations-de-mise-sur-le-marche-amm
https://ansm.sante.fr/actualites/suspension-des-autorisations-de-mise-sur-le-marche-amm-des-medicaments-a-base-dhydroxyethylamidon
2022
false
false
false
France
French
pharmacovigilance note
Safety-Based drug withdrawals
hydroxyethyl starch derivatives
hydroxyethylstarch
plasma substitutes
infusions, intravenous
hypovolemia
---
https://ansm.sante.fr/informations-de-securite/klipal-codeine-paracetamol-codeine-devient-klipal-paracetamol-codeine-et-change-dexcipients-attention-aux-erreurs-medicamenteuses
2022
false
false
false
France
French
pharmacovigilance note
drug information
acetaminophen
drug combinations
acetaminophen, codeine drug combination
administration, oral
codeine phosphate
codeine and paracetamol
medication errors
analgesics
---
https://ansm.sante.fr/informations-de-securite/neorecormon-epoetine-beta-risque-derreur-medicamenteuse-absence-potentielle-detiquette-sur-les-seringues-preremplies-de-neorecormon-en-boite-de-1
2022
false
false
false
France
French
pharmacovigilance note
---
https://ansm.sante.fr/actualites/medicament-lytos-et-complement-alimentaire-lithos-rappel-des-recommandations-pour-eviter-une-confusion-entre-les-deux-produits
2022
false
false
false
France
French
pharmacovigilance note
medication errors
guideline
---
https://ansm.sante.fr/informations-de-securite/haldol-2-mg-ml-solution-buvable-haloperidol-rappel-de-la-dose-unique-maximale-pouvant-etre-administree-avec-le-dispositif-compte-gouttes
2022
false
false
false
France
French
administration, oral
pharmaceutical solutions
-
pharmacovigilance note
haloperidol
antipsychotic agents
medication errors
haloperidol
Dropper container
---
https://recalls-rappels.canada.ca/fr/avis-rappel/evusheld-tixagevimab-et-cilgavimab-injectables-risque-echec-prophylaxie-ou-du
2022
false
false
false
Canada
French
English
pharmacovigilance note
canada
drug resistance, viral
cilgavimab and tixagevimab drug combination
drug combinations
tixagevimab
cilgavimab
tixagevimab and cilgavimab
antibodies, monoclonal
antiviral agents
Evusheld
injections, intramuscular
COVID-19
COVID-19
Pre-Exposure Prophylaxis
SARS-CoV-2 variants
---
Janus Kinase Inhibitors and the Risk of Major Adverse Cardiovascular Events, Thrombosis
(Including Fatal Events) and Malignancy
https://recalls-rappels.canada.ca/fr/avis-rappel/inhibiteurs-janus-kinase-et-risque-manifestation-cardiovasculaire-grave-thrombose-y
2022
false
false
false
Canada
French
English
Janus Kinase Inhibitors
pharmacovigilance note
cardiovascular diseases
thrombosis
neoplasms
abrocitinib
Fedratinib
ruxolitinib
administration, oral
baricitinib
JAK Inhibitor
upadacitinib
tofacitinib
canada
---
https://ansm.sante.fr/informations-de-securite/imbruvica-ibrutinib-nouvelles-mesures-de-reduction-des-risques-incluant-des-recommandations-de-modifications-de-dose-en-raison-du-risque-accru-devenements-cardiaques-graves
2022
false
false
false
France
French
pharmacovigilance note
risk management
ibrutinib
ibrutinib
arrhythmias, cardiac
heart failure
ibrutinib
risk factors
continuity of patient care
adult
aged
administration, oral
---
https://ansm.sante.fr/informations-de-securite/prenoxad-0-91-mg-ml-naloxone-solution-injectable-en-seringue-preremplie-absence-potentielle-daiguilles-dans-le-kit-dutilisation
2022
false
false
false
France
French
pharmacovigilance note
---
https://ansm.sante.fr/actualites/retour-dinformation-sur-le-prac-de-novembre-2022-24-27-octobre
2022
false
false
false
France
French
pharmacovigilance note
Drug-Related side effects and adverse reactions
---
https://ansm.sante.fr/informations-de-securite/nulojix-belatacept-modification-de-la-dose-dentretien-de-5-a-6-mg-kg-en-raison-dun-nouveau-procede-de-fabrication
2022
false
false
false
France
French
guidelines for drug use
Abatacept
infusions, intravenous
immunosuppressive agents
belatacept
graft rejection
medication errors
pharmacovigilance note
---
https://ansm.sante.fr/informations-de-securite/xalkori-crizotinib-troubles-de-la-vision-incluant-un-risque-de-perte-de-vision-severe-et-necessite-de-surveillance-des-patients-pediatriques
2022
false
false
false
France
French
pharmacovigilance note
Crizotinib
crizotinib
vision disorders
continuity of patient care
blindness
child
risk
vision screening
vision disorders
vision disorders
---
OCALIVA (obeticholic acid) – New Contraindication for the Treatment of Primary Biliary
Cholangitis (PBC)
https://recalls-rappels.canada.ca/fr/avis-rappel/ocaliva-acide-obeticholique-nouvelle-contre-indication-pour-traitement-cholangite
2022
false
false
false
Canada
French
English
pharmacovigilance note
administration, oral
obeticholic acid
Primary Biliary Cholangitis
---
https://ansm.sante.fr/informations-de-securite/terlipressine-insuffisance-respiratoire-severe-ou-fatale-et-sepsis-choc-septique-chez-les-patients-atteints-dun-syndrome-hepatorenal-de-type-1-shr-de-type-1
2022
false
false
false
France
French
pharmacovigilance note
Terlipressin
infusions, intravenous
injections, intravenous
terlipressin
respiratory insufficiency
hepatorenal syndrome
Hepatorenal syndrome type 1
shock, septic
sepsis
risk
renal insufficiency
hepatic insufficiency
Terlipressin
continuity of patient care
---
https://ansm.sante.fr/informations-de-securite/specialites-a-base-de-fer-pour-injection-intraveineuse-iv-specialites-non-interchangeables-et-risque-derreur-medicamenteuse
2022
false
false
false
France
French
pharmacovigilance note
medication errors
wrong drug administered
ferric compounds
iron, parenteral preparations
injections, intravenous
infusions, intravenous
---
https://ansm.sante.fr/tableau-marr/vedolizumab
2022
false
false
false
France
French
pharmacovigilance note
risk management
vedolizumab
infusions, intravenous
injections, subcutaneous
guidelines for drug use
drug monitoring
continuity of patient care
package leaflet
Infections
leukoencephalopathy, progressive multifocal
vedolizumab
antibodies, monoclonal, humanized
---
https://ansm.sante.fr/actualites/le-risque-de-myocardite-et-pericardite-apres-la-vaccination-covid-19-est-confirme-mais-peu-frequent-et-devolution-favorable
2022
false
false
false
France
French
pharmacovigilance note
COVID-19 Vaccines
COVID-19
myocarditis
pericarditis
vaccination
risk
risk assessment
myocarditis
pericarditis
mRNA Vaccine
adult
young adult
mRNA Vaccines
---
https://ansm.sante.fr/actualites/traitement-des-varices-rappel-des-conduites-a-tenir-pour-reduire-les-risques-cardiovasculaires-lies-a-lutilisation-des-sclerosants-veineux
2022
false
false
false
France
French
pharmacovigilance note
---
https://ansm.sante.fr/informations-de-securite/methotrexate-haute-dose-mtx-hd-lansm-rappelle-les-mesures-generales-de-prevention-du-risque-de-nephrotoxicite
2022
false
false
false
France
French
pharmacovigilance note
guidelines for drug use
methotrexate
High-Dose Methotrexate Regimen
methotrexate
antimetabolites, antineoplastic
antimetabolites, antineoplastic
hematologic neoplasms
osteosarcoma
risk
acute kidney injury
renal insufficiency, acute
Methotrexate overdose (disorder)
kidney function tests
adult
aged
risk management
drug interactions
continuity of patient care
methotrexate
methotrexate
methotrexate
poisoning
poisoning
leucovorin
glucarpidase
---
https://recalls-rappels.canada.ca/fr/avis-rappel/casirivimab-et-imdevimab-risque-eleve-echec-therapeutique-en-raison-circulation-du
2022
false
false
false
Canada
French
English
pharmacovigilance note
COVID-19
casirivimab and imdevimab drug combination
risk
drug combinations
imdevimab
casirivimab
treatment failure
canada
SARS-CoV-2 variants
---
https://ansm.sante.fr/informations-de-securite/divalcote-divalproate-de-sodium-attention-au-risque-derreur-medicamenteuse-en-cas-de-substitution-avec-les-generiques-contenant-du-valproate-de-sodium
2022
false
false
false
France
French
pharmacovigilance note
medication errors
risk
---
Health Canada safety review finds link between the use of Xeljanz and Xeljanz XR (tofacitinib)
and increased risk of serious heart-related issues and cancer
https://recalls-rappels.canada.ca/fr/avis-rappel/examen-innocuite-mene-sante-canada-revele-lien-entre-prise-tofacitinib-xeljanz-et
2022
false
false
false
Canada
French
English
risk
tofacitinib
pharmacovigilance note
tofacitinib
risk factors
arthritis, rheumatoid
colitis, ulcerative
tofacitinib
guidelines for drug use
canada
heart diseases
neoplasms
thrombosis
Janus Kinase Inhibitors
Janus Kinase Inhibitors
patient education handout
arthritis, psoriatic
serious infection
---
PAXLOVID (nirmatrelvir and ritonavir) - Dosing and Dispensing in Renal Impairment,
Risk of Serious Adverse Reactions Due to Drug Interactions, and English-Only Labels
https://recalls-rappels.canada.ca/fr/avis-rappel/paxlovid-nirmatrelvir-et-ritonavir-posologie-et-administration-en-presence-insuffisance
2022
false
false
false
Canada
French
English
pharmacovigilance note
canada
drug therapy, combination
ritonavir
antiviral agents
lactams
proline
leucine
nitriles
renal insufficiency
drug interactions
COVID-19
adult
administration, oral
Viral Protease Inhibitors
nirmatrelvir and ritonavir
nirmatrelvir and ritonavir drug combination
nirmatrelvir
---
https://ansm.sante.fr/informations-de-securite/acces-compassionnel-a-enfortumab-vedotin-maintien-de-la-suspension-et-recommandations-sur-la-prise-en-charge-des-toxicites-cutanees
2022
false
false
false
France
French
pharmacovigilance note
drug eruptions
stevens-johnson syndrome
epidermal necrolysis, toxic
package leaflet
practice guideline
continuity of patient care
infusions, intravenous
enfortumab vedotin
enfortumab vedotin
---
https://ansm.sante.fr/informations-de-securite/periactine-4-mg-cyproheptadine-risques-lies-a-lutilisation-non-conforme-comme-orexigene-a-des-fins-esthetiques
2022
false
false
false
France
French
administration, oral
Off-Label use
risk
pharmacovigilance note
cyproheptadine
appetite stimulants
weight gain
adult
child
---
Domperidone and serious ventricular arrhythmias, QT interval prolongation and sudden
cardiac death
https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/medeffet-canada/infovigilance-produits-sante/janvier-2022.html#domperidone
2022
false
false
false
Canada
French
English
journal article
pharmacovigilance note
domperidone
---
https://ansm.sante.fr/informations-de-securite/tegeline-50-mg-ml-immunoglobuline-humaine-normale-iv-poudre-et-solvant-pour-solution-pour-perfusion-information-sur-le-risque-dinsuffisance-renale
2022
false
false
false
France
French
infusions, intravenous
pharmacovigilance note
risk
immunoglobulins, intravenous
immunologic factors
acute kidney injury
renal insufficiency, acute
guidelines for drug use
risk factors
immunoglobulins, normal human, for intravascular adm.
continuity of patient care
drug monitoring
sucrose
---
BEOVU (brolucizumab) – Risk of Intraocular Inflammation, Retinal Vasculitis and/or
Retinal Vascular Occlusion
https://recalls-rappels.canada.ca/fr/avis-rappel/beovu-brolucizumab-risque-inflammation-intraoculaire-vascularite-retinienne-etou
2022
false
false
false
Canada
French
English
pharmacovigilance note
brolucizumab
intravitreal injections
Product containing only brolucizumab in parenteral dose form (medicinal product form)
canada
wet macular degeneration
brolucizumab
retinal vasculitis
Retinal Vascular Occlusion
---
https://ansm.sante.fr/informations-de-securite/decongestionnant-nasal-balsolene-attention-aux-erreurs-de-voie-dadministration
2022
false
false
false
France
French
pharmacovigilance note
medication errors
fumigation
drug combinations
Eucalyptus Oil
oils, volatile
Niaouli oil
benzoin
Drug misadministration
Levomenthol
nasal decongestants
Other cold preparations
---
https://ansm.sante.fr/informations-de-securite/mavenclad-10-mg-comprimes-cladribine-risque-datteintes-hepatiques-graves-et-nouvelles-recommandations-sur-le-controle-de-la-fonction-hepatique
2022
false
false
false
France
French
pharmacovigilance note
guidelines for drug use
continuity of patient care
administration, oral
cladribine
cladribine
Chemical and Drug Induced Liver Injury
cladribine
liver function tests
---
https://ansm.sante.fr/informations-de-securite/anagrelide-xagrid-et-generiques-risque-de-thrombose-incluant-un-infarctus-cerebral-en-cas-darret-brutal-du-traitement
2022
false
false
false
France
French
thrombosis
anagrelide
pharmacovigilance note
cerebral infarction
withdrawing treatment
---
https://ansm.sante.fr/actualites/prolapsus-et-incontinence-urinaire-lansm-suspend-lutilisation-de-plusieurs-dispositifs-du-fabricant-microval-pour-raison-reglementaire
2022
false
false
false
France
French
pharmacovigilance note
---
https://ansm.sante.fr/informations-de-securite/specialites-a-base-de-donepezil-aricept-et-generiques-mise-a-jour-de-linformation-produit-concernant-les-troubles-de-la-conduction-cardiaque-incluant-lallongement-de-lintervalle-qtc-et-les-torsades-de-pointes
2022
false
false
false
France
French
pharmacovigilance note
Donepezil
donepezil
administration, oral
long qt syndrome
torsades de pointes
risk factors
cholinesterase inhibitors
---
https://ansm.sante.fr/informations-de-securite/bupivacaine-mylan-20-mg-4-ml-solution-injectable-pour-voie-intra-rachidienne-en-ampoule-echecs-rencontres-lors-de-rachianesthesies
2022
false
false
false
France
French
pharmacovigilance note
---
https://ansm.sante.fr/informations-de-securite/trimebutine-injectable-debridat-et-trimebutine-medisol-risque-de-toxicite-cardiaque-en-cas-de-mesusage
2022
false
false
false
France
French
pharmacovigilance note
Off-Label use
Trimebutine Maleate Salt
injections, intramuscular
injections, intravenous
Trimebutine Maleate Salt
cardiopulmonary arrest
heart diseases
trimebutine
---
https://ansm.sante.fr/actualites/lutilisation-de-vaccins-vivants-attenues-comme-le-ror-ou-bcg-doit-etre-differee-chez-les-enfants-de-meres-traitees-par-infliximab-pendant-la-grossesse-ou-lallaitement
https://ansm.sante.fr/informations-de-securite/infliximab-remicade-flixabi-inflectra-remsima-et-zessly-differer-lutilisation-de-vaccins-vivants-chez-les-nourrissons-exposes-in-utero-ou-pendant-lallaitement
2022
false
false
false
France
French
pharmacovigilance note
vaccines, attenuated
pregnancy
infant
Vaccine exposure during pregnancy
vaccination
Infliximab
breast feeding
immunologic deficiency syndromes
morbilli, combinations with parotitis and rubella, live attenuated
tuberculosis, live attenuated
---
https://ansm.sante.fr/informations-de-securite/xylocaine-adrenaline-injectables-nouvel-etiquetage-pour-eviter-les-erreurs-medicamenteuses
2022
false
false
false
France
French
pharmacovigilance note
injections
epinephrine
lidocaine
drug labeling
drug combinations
medication errors
lidocaine, combinations
---
Sotrovimab for Injection - Risk of Treatment Failure due to Circulation of SARS-CoV-2
Omicron BA.2 Subvariant
https://recalls-rappels.canada.ca/fr/avis-rappel/sotrovimab-pour-injection-risque-echec-therapeutique-en-raison-circulation-du-ba2-sous
2022
false
false
false
Canada
French
English
COVID-19
risk
pharmacovigilance note
treatment failure
sotrovimab
SARS-CoV-2 variants
new coronavirus variant
infusions, intravenous
sotrovimab
---
https://ansm.sante.fr/actualites/prolia-denosumab-et-risque-potentiel-de-fractures-vertebrales-multiples-a-larret-du-traitement
2022
false
false
France
French
Denosumab
spinal fractures
risk
Fractures, Multiple
Rebound effect
Multiple Vertebral Fractures
denosumab
osteoporosis, postmenopausal
pharmacovigilance note
injections, subcutaneous
guidelines for drug use
---
Certain sulfonamide diuretics and the risk of choroidal effusion with acute myopia
and/or acute angle-closure glaucoma
https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/medeffet-canada/infovigilance-produits-sante/mars-2021.html#a10
2021
false
false
false
Canada
French
English
pharmacovigilance note
diuretics
Sulfonamide diuretic (substance)
Choroidal effusion
myopia
glaucoma, angle-closure
acute disease
choroid diseases
acetazolamide
chlorthalidone
hydrochlorothiazide
indapamide
metolazone
sulfonamides
---
https://canadiensensante.gc.ca/recall-alert-rappel-avis/hc-sc/2021/75211a-fra.php
2021
false
false
false
Canada
French
English
pharmacovigilance note
risk
thrombosis
thrombocytopenia
canada
risk assessment
covid-19, viral vector, non-replicating
vaccination
pneumonia, viral
coronavirus infections
pandemics
viral vaccines
coronavirus infections
COVID-19
COVID-19 Vaccines
---
https://ansm.sante.fr/informations-de-securite/covid-19-vaccine-astrazeneca-risque-de-thrombocytopenie-et-de-troubles-de-la-coagulation
2021
false
false
false
France
French
risk assessment
covid-19, viral vector, non-replicating
adenoviruses, simian
thromboembolism
thrombosis
thrombocytopenia
pharmacovigilance note
pneumonia, viral
coronavirus infections
pandemics
viral vaccines
coronavirus infections
COVID-19
COVID-19 Vaccines
---
https://ansm.sante.fr/informations-de-securite/zolgensma-r-onasemnogene-abeparvovec-risque-de-microangiopathie-thrombotique
2021
false
false
false
France
French
pharmacovigilance note
Onasemnogene Abeparvovec
onasemnogene abeparvovec
thrombotic microangiopathies
gene therapy
spinal muscular atrophies of childhood
infusions, intravenous
guidelines for drug use
drug monitoring
continuity of patient care
infant
onasemnogene abeparvovec-xioi
genetic therapy
Zolgensma
biological products
recombinant fusion proteins
---
https://ansm.sante.fr/informations-de-securite/tecentriq-atezolizumab-risque-de-reactions-cutanees-severes
2021
false
false
false
France
French
pharmacovigilance note
atezolizumab
risk
stevens-johnson syndrome
epidermal necrolysis, toxic
drug hypersensitivity syndrome
atezolizumab
antineoplastic agents
antibodies, monoclonal
---
https://ansm.sante.fr/informations-de-securite/cabazitaxel-accord-60-mg-risque-derreurs-medicamenteuses-et-de-confusion-avec-jevtana-60-mg-1-5-ml
2021
false
false
false
France
French
pharmacovigilance note
cabazitaxel
medication errors
infusions, intravenous
wrong drug administered
taxoids
---
https://ansm.sante.fr/informations-de-securite/vaxzevria-covid-19-vaccine-astrazeneca-lien-entre-le-vaccin-et-la-survenue-de-thromboses-en-association-avec-une-thrombocytopenie
2021
false
false
false
France
French
pharmacovigilance note
vaccination
viral vaccines
covid-19, viral vector, non-replicating
thrombosis
thrombocytopenia
risk assessment
thromboembolism
autoantibodies
platelet factor 4
ChAdOx1 nCoV-19
pneumonia, viral
coronavirus infections
pandemics
coronavirus infections
COVID-19
COVID-19 Vaccines
---
https://ansm.sante.fr/actualites/retour-dinformation-sur-le-prac-davril-2021
2021
false
false
false
France
French
pharmacovigilance note
risk assessment
drug evaluation
thrombosis
thrombocytopenia
drug evaluation
covid-19, viral vector, non-replicating
viral vaccines
vaccination
capillary leak syndrome
europe
ChAdOx1 nCoV-19
pneumonia, viral
coronavirus infections
pandemics
coronavirus infections
COVID-19
COVID-19 Vaccines
---
https://ansm.sante.fr/informations-de-securite/eylea-40-mg-ml-aflibercept-en-injection-intravitreenne-risque-plus-eleve-daugmentation-de-la-pression-intraoculaire-a-la-suite-de-lutilisation-de-la-seringue-preremplie
2021
false
false
false
France
French
pharmacovigilance note
intravitreal injections
aflibercept
ocular hypertension
aflibercept
Pre-filled Syringe
drug compounding
intravitreal injections
aflibercept
guidelines for drug use
continuity of patient care
Inappropriate preparation of medication
recombinant fusion proteins
receptors, vascular endothelial growth factor
recombinant fusion proteins
receptors, vascular endothelial growth factor
---
Janssen COVID-19 Vaccine and the Risk of Thrombosis with Thrombocytopenia
https://canadiensensante.gc.ca/recall-alert-rappel-avis/hc-sc/2021/75479a-fra.php
2021
false
false
false
Canada
French
English
vaccination
thrombocytopenia
thrombosis
canada
pharmacovigilance note
pneumonia, viral
coronavirus infections
pandemics
viral vaccines
coronavirus infections
COVID-19
COVID-19 Vaccines
---
Bamlanivimab - Potential Risk of Treatment Failure Due to Circulation of Resistant
SARS-CoV-2 Variants
https://canadiensensante.gc.ca/recall-alert-rappel-avis/hc-sc/2021/75503a-fra.php
2021
false
false
false
Canada
French
pharmacovigilance note
antibodies, monoclonal, humanized
antiviral agents
risk
treatment failure
new coronavirus variant
drug resistance, viral
adult
adolescent
bamlanivimab
SARS-CoV-2
COVID-19
---
https://ansm.sante.fr/informations-de-securite/covid-19-vaccine-janssen-lien-entre-le-vaccin-et-la-survenue-de-thromboses-en-association-avec-une-thrombocytopenie
2021
false
false
false
France
French
pharmacovigilance note
thrombosis
thrombocytopenia
vaccination
covid-19, viral vector, non-replicating
pneumonia, viral
coronavirus infections
pandemics
viral vaccines
coronavirus infections
COVID-19
COVID-19 Vaccines
---
https://ansm.sante.fr/informations-de-securite/rovalcyte-r-50-mg-ml-poudre-pour-solution-buvable-valganciclovir-modification-des-graduations-de-la-nouvelle-seringue-pour-administration-orale-de-mg-a-ml
2021
false
false
false
France
French
pharmacovigilance note
Valganciclovir
---
https://ansm.sante.fr/informations-de-securite/vaxzevria-covid-19-vaccine-astrazeneca-risque-de-thromboses-en-association-avec-une-thrombocytopenie-mise-a-jour-de-linformation
2021
false
false
false
France
French
pharmacovigilance note
guidelines for drug use
thrombosis
continuity of patient care
drug monitoring
thrombocytopenia
thrombosis
vaccination
covid-19, viral vector, non-replicating
Drug Induced Thrombocytopenia
adenoviruses, simian
thrombotic thrombocytopenic syndrome
ChAdOx1 nCoV-19
viral vaccines
coronavirus infections
coronavirus infections
pneumonia, viral
pandemics
COVID-19
COVID-19 Vaccines
---
Labelling update regarding the use of non-steroidal anti-inflammatory drugs (NSAIDs)
beyond 20 weeks of pregnancy and risk of kidney damage to unborn babies
https://canadiensensante.gc.ca/recall-alert-rappel-avis/hc-sc/2021/75763a-fra.php
2021
false
false
false
Canada
French
pharmacovigilance note
pregnancy
fetus
pregnancy trimester, second
anti-inflammatory agents, non-steroidal
kidney diseases
pregnancy trimester, third
anti-inflammatory agents, non-steroidal
fetal diseases
---
https://ansm.sante.fr/informations-de-securite/venclyxto-r-v-venetoclax-comprimes-pellicules-recommandations-actualisees-concernant-le-syndrome-de-lyse-tumorale-slt-chez-les-patients-atteints-de-leucemie-lymphoide-chronique
2021
false
false
false
France
French
pharmacovigilance note
guidelines for drug use
venetoclax
tumor lysis syndrome
leukemia, lymphocytic, chronic, B-Cell
venetoclax
antineoplastic agents
administration, oral
sulfonamides
Bridged Bicyclo Compounds, Heterocyclic
---
Dopamine agonist withdrawal syndrome
https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/medeffet-canada/infovigilance-produits-sante/juin-2021.html#a5.1
2021
false
false
false
Canada
French
English
pharmacovigilance note
journal article
substance withdrawal syndrome
dopamine agonists
dopamine agonists
Pramipexole
quinagolide
ropinirole
risk factors
substance withdrawal syndrome
signs and symptoms
dopamine agonist withdrawal syndrome
aminoquinolines
indoles
---
COVID-19 vaccines and reports of myocarditis and/or pericarditis
https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/medeffet-canada/infovigilance-produits-sante/juin-2021.html#a3.2
2021
false
false
false
Canada
French
pharmacovigilance note
myocarditis
pericarditis
COVID-19 Vaccines
adolescent
adult
COVID-19
mRNA Vaccine
covid-19, RNA-based vaccine
vaccination
mRNA Vaccines
vaccines, synthetic
mRNA Vaccine
---
CHAMPIX (varenicline) — Potential Risk Posed by Long-Term Exposure to Nitrosamine
Impurity, N-nitrosovarenicline, Exceeding Acceptable Intake Limit
https://canadiensensante.gc.ca/recall-alert-rappel-avis/hc-sc/2021/75961a-fra.php
2021
false
false
false
Canada
French
English
Varenicline
varenicline
drug contamination
nitrosamines
nitrosamines
neoplasms
mutation
pharmacovigilance note
---
Health Canada updates Pfizer-BioNTech and Moderna COVID-19 vaccine labels to include
information on myocarditis and pericarditis
https://canadiensensante.gc.ca/recall-alert-rappel-avis/hc-sc/2021/75959a-fra.php
2021
false
false
false
Canada
French
English
COVID-19 Vaccines
vaccination
COVID-19
pericarditis
myocarditis
mRNA Vaccine
pharmacovigilance note
covid-19, RNA-based vaccine
mRNA Vaccines
vaccines, synthetic
mRNA Vaccine
---
https://ansm.sante.fr/informations-de-securite/vaxzevria-covid-19-vaccine-astrazeneca-contre-indication-chez-les-personnes-ayant-des-antecedents-de-syndrome-de-fuite-capillaire-sfc
2021
false
false
false
France
French
pharmacovigilance note
COVID-19 Vaccines
vaccination
COVID-19
capillary leak syndrome
ChAdOx1 nCoV-19
---
https://ansm.sante.fr/informations-de-securite/xeljanz-tofacitinib-augmentation-du-risque-devenements-cardiovasculaires-indesirables-majeurs-et-de-tumeurs-malignes-avec-lutilisation-de-tofacitinib-en-comparaison-aux-antitnf-alpha
2021
false
false
false
France
French
pharmacovigilance note
tofacitinib
cardiovascular diseases
risk
neoplasms
tofacitinib
tofacitinib
arthritis, rheumatoid
major adverse cardiovascular events
pyrimidines
pyrroles
piperidines
pyrimidines
pyrroles
piperidines
---
https://ansm.sante.fr/informations-de-securite/covid-19-vaccine-janssen-contre-indication-chez-les-personnes-ayant-des-antecedents-de-syndrome-de-fuite-capillaire-et-mise-a-jour-concernant-le-syndrome-de-thromboses-associees-a-une-thrombocytopenie
2021
false
false
false
France
French
COVID-19 Vaccines
vaccination
COVID-19
pharmacovigilance note
capillary leak syndrome
thrombocytopenia
thrombosis
COVID-19 Vaccines
---
https://ansm.sante.fr/informations-de-securite/dispositifs-intra-uterins-ancora-et-novaplus-seuls-ou-en-set-complet-de-pose-sethygyn-retrait-preventif-des-diu-poses-chez-les-patientes-avant-mars-2019
https://ansm.sante.fr/actualites/dispositifs-intra-uterins-ancora-et-novaplus-seuls-ou-en-kit-de-pose-sethygyn-retrait-preventif-des-diu-poses-avant-mars-2019
2021
false
false
false
France
French
pharmacovigilance note
Safety-Based medical device withdrawals
intrauterine devices, copper
intrauterine devices, medicated
---
https://ansm.sante.fr/tableau-marr/delamanide
2021
false
false
false
France
French
risk management
delamanid
administration, oral
delamanid
patient education handout
pregnancy
breast feeding
delamanid
long qt syndrome
pharmacovigilance note
drug resistance, bacterial
antibiotics, antitubercular
antibiotics, antitubercular
OPC-67683
OPC-67683
nitroimidazoles
oxazoles
nitroimidazoles
oxazoles
---
https://ansm.sante.fr/informations-de-securite/laroxyl-40-mg-ml-solution-buvable-changement-du-dispositif-dadministration
2021
false
false
false
France
French
pharmacovigilance note
administration, oral
pharmaceutical solutions
amitriptyline
amitriptyline
amitriptyline hydrochloride
Dropper
---
Health Canada updates Pfizer-BioNTech COVID-19 vaccine label to reflect very rare
reports of Bell's Palsy
https://canadiensensante.gc.ca/recall-alert-rappel-avis/hc-sc/2021/76203a-fra.php
2021
false
false
false
Canada
French
English
pharmacovigilance note
COVID-19 Vaccines
COVID-19
vaccination
bell palsy
covid-19, RNA-based vaccine
canada
---
https://canadiensensante.gc.ca/recall-alert-rappel-avis/hc-sc/2021/76365a-fra.php
2021
false
false
false
Canada
French
pharmacovigilance note
COVID-19
---
https://ansm.sante.fr/actualites/suivi-des-effets-indesirables-des-medicaments-utilises-dans-la-prise-en-charge-de-la-covid-19-en-date-du-07-08-2021
2021
false
false
false
France
French
pharmacovigilance note
COVID-19
Drug-Related side effects and adverse reactions
---
https://ansm.sante.fr/informations-de-securite/topalgic-100-mg-ml-et-contramal-100-mg-ml-solution-buvable-tramadol-rappels-de-bon-usage-et-evolution-des-boites-pour-limiter-le-risque-de-surdosage
2021
false
false
false
France
French
pharmacovigilance note
guideline
tramadol
pharmaceutical solutions
administration, oral
medication errors
tramadol
analgesics, opioid
---
https://ansm.sante.fr/informations-de-securite/champix-varenicline-rappel-de-lots-en-raison-de-la-presence-de-limpurete-n-nitrosovarenicline-a-un-taux-superieur-a-la-limite-acceptable
2021
false
false
false
France
French
pharmacovigilance note
Varenicline
drug contamination
nitrosamines
---
https://ansm.sante.fr/informations-de-securite/rappels-sur-le-bon-usage-des-specialites-a-base-de-dinoprostone-pour-limiter-les-risques-dhyperstimulation-uterine-de-rupture-uterine-et-de-mort-foetale-neonatale
2021
false
false
false
France
French
pharmacovigilance note
dinoprostone
guidelines for drug use
administration, intravaginal
drug evaluation
dinoprostone
fetal death
risk
pregnancy
Neonatal Death
risk factors
Uterine hyperstimulation
uterine rupture
---
https://recalls-rappels.canada.ca/fr/avis-rappel/comirnaty-vaccin-contre-covid-19-arnm-aussi-appele-vaccin-contre-covid-19-pfizer
2021
false
false
false
Canada
French
COVID-19 Vaccines
drug information
COVID-19
child
canada
mRNA Vaccine
pharmacovigilance note
covid-19, RNA-based vaccine
mRNA Vaccines
---
https://ansm.sante.fr/informations-de-securite/bitherapie-casirivimab-et-imdevimab-ronapreve-risque-derreur-medicamenteuse-et-modification-de-la-posologie-pour-le-traitement-de-la-covid-19
2021
false
false
false
France
French
pharmacovigilance note
guidelines for drug use
casirivimab and imdevimab drug combination
casirivimab and imdevimab
---
https://ansm.sante.fr/actualites/deces-denfants-suite-a-lingestion-accidentelle-de-methadone-rappel-des-regles-de-bon-usage
2021
false
false
false
France
French
pharmacovigilance note
guidelines for drug use
methadone
child
Accidental ingestion of drug
accident prevention
adolescent
accidents, home
poisoning
death
---
https://ansm.sante.fr/informations-de-securite/mitomycine-substipharm-20-mg-utilisation-dun-filtre-pour-eviter-les-reactions-liees-a-linjection-de-particules
2021
false
false
false
France
French
guidelines for drug use
pharmacovigilance note
mitomycin
filtration
---
https://ansm.sante.fr/informations-de-securite/Zerbaxa-R-ceftolozane-tazobactam-1-g-0-5-g-poudre-pour-solution-a-diluer-pour-perfusion-RAPPEL-DE-LOT-MONDIAL
2021
false
false
false
France
French
pharmacovigilance note
ceftolozane, tazobactam drug combination
drug contamination
ceftolozane
drug combinations
Safety-Based drug withdrawals
infusions, intravenous
Tazobactam
cephalosporins
penicillanic acid
---
Important Safety Information on SUBOXONE (buprenorphine and naloxone) and the Risk
of Overdose or Underdose when Switching Between Dosage Forms or Routes of Administration
https://canadiensensante.gc.ca/recall-alert-rappel-avis/hc-sc/2021/74719a-fra.php
2021
false
false
false
Canada
French
English
pharmacovigilance note
---
GILENYA (fingolimod) - Risk of Liver Injury
https://canadiensensante.gc.ca/recall-alert-rappel-avis/hc-sc/2021/74803a-fra.php
2021
false
false
false
Canada
French
English
pharmacovigilance note
Chemical and Drug Induced Liver Injury
Fingolimod Hydrochloride
fingolimod
administration, oral
immunosuppressive agents
drug monitoring
guidelines for drug use
continuity of patient care
liver function tests
liver failure, acute
---
https://ansm.sante.fr/informations-de-securite/prodilantin-75-mg-ml-fosphenytoine-sodique-equivalent-a-50-mg-ml-de-phenytoine-sodique-ep-nouvelle-diffusion-des-guides-posologiques-adulte-et-enfant-afin-deviter-lutilisation-chez-les-enfants-de-moins-de-5-ans-et-les-erreurs-medicamenteuses
2021
false
false
false
France
French
pharmacovigilance note
guidelines for drug use
medication errors
fosphenytoin sodium
adult
child
status epilepticus
emergency treatment
anticonvulsants
fosphenytoin
administration, intravenous
continuity of patient care
fosphenytoin
phenytoin
phenytoin
---
https://www.ansm.sante.fr/actualites/traitement-contre-lacne-severe-avec-isotretinoine-orale-lansm-informe-dun-risque-potentiel-de-troubles-neuro-developpementaux-en-cas-dexposition-pendant-la-grossesse
2021
false
false
false
France
French
pregnancy
acne vulgaris
administration, oral
isotretinoin
dermatologic agents
isotretinoin
Product containing isotretinoin in oral dose form (medicinal product form)
Neurodevelopmental Disorders
infant, newborn
infant
child
pharmacovigilance note
guidelines for drug use
prenatal exposure delayed effects
---
