Preferred Label : Safety-Based drug withdrawals;
MeSH definition : Removal of a drug from the market due to the identification of an intrinsic property
of the drug that results in a serious risk to public health.;
MeSH synonym : Drug Withdrawal, Safety-Based; Drug Withdrawals, Safety-Based; Drug Withdrawals Due to Safety; Safety-Based Drug Withdrawal; Safety Based Drug Withdrawal; Drug Withdrawal Due to Safety; safety based drug withdrawals;
MeSH annotation : DRUG RECALLS is also available;
Origin ID : D056737;
UMLS CUI : C2717885;
Allowable qualifiers
Metaterm(s)
Record concept(s)
See also
See also (suggested by CISMeF)
Semantic type(s)
Removal of a drug from the market due to the identification of an intrinsic property
of the drug that results in a serious risk to public health.
https://ansm.sante.fr/actualites/lansm-suspend-lactivite-de-linstitut-georges-lopez-et-rappelle-les-lots-de-celsior-fabriques-depuis-mars-2024
2025
false
false
false
France
French
Safety-Based drug withdrawals
drug information
organ preservation solutions
---
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://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/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/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://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://ansm.sante.fr/actualites/retour-dinformation-sur-le-prac-de-mai-2024-13-16-mai
2024
false
false
false
France
French
drug information
Safety-Based drug withdrawals
17 alpha-Hydroxyprogesterone Caproate
europe
---
https://ansm.sante.fr/tableau-acces-derogatoire/oxbryta-voxelotor
2024
false
false
false
France
French
risk management
voxelotor
voxelotor
administration, oral
hematologic agents
drug information
anemia, hemolytic
anemia, sickle cell
Safety-Based drug withdrawals
---
https://ansm.sante.fr/informations-de-securite/adakveo-crizanlizumab-retrait-de-lautorisation-de-mise-sur-le-marche-en-raison-dun-manque-defficacite
2023
false
false
false
France
French
drug information
Drug effect lack of
crizanlizumab
crizanlizumab
anemia, sickle cell
Vaso-Occlusive Crisis
Safety-Based drug withdrawals
---
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/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://www.ema.europa.eu/en/medicines/human/EPAR/qutavina
2021
false
false
false
Netherlands
French
English
Safety-Based drug withdrawals
teriparatide
drug evaluation
summary of product characteristics
teriparatide
treatment outcome
syndication feed
package leaflet
---
https://www.ansm.sante.fr/actualites/arret-de-commercialisation-du-medicament-esmya-ulipristal
2021
false
false
false
France
French
drug information
Safety-Based drug withdrawals
ulipristal acetate
fibroid uterus
ulipristal
leiomyoma
norpregnadienes
---
https://www.ansm.sante.fr/actualites/suspension-temporaire-par-mesure-de-precaution-de-lutilisation-du-vaccin-astrazeneca-en-france-dans-lattente-dun-avis-de-lagence-europeenne-du-medicament-ema
2021
false
false
false
France
French
pharmacovigilance note
Safety-Based drug withdrawals
france
vaccination
covid-19, viral vector, non-replicating
pneumonia, viral
coronavirus infections
pandemics
viral vaccines
coronavirus infections
COVID-19
COVID-19 Vaccines
---
https://canadiensensante.gc.ca/recall-alert-rappel-avis/hc-sc/2020/73939a-fra.php
2020
false
false
false
Canada
French
pharmacovigilance note
Safety-Based drug withdrawals
canada
ulipristal acetate
Chemical and Drug Induced Liver Injury
ulipristal
leiomyoma
fibroid uterus
norpregnadienes
---
https://www.ansm.sante.fr/actualites/esmya-ulipristal-5-mg-retrait-de-lautorisation-de-mise-sur-le-marche-amm
2020
false
false
false
France
French
pharmacovigilance note
Safety-Based drug withdrawals
ulipristal acetate
drug evaluation
risk assessment
Chemical and Drug Induced Liver Injury
ulipristal
fibroid uterus
leiomyoma
norpregnadienes
---
https://www.ansm.sante.fr/actualites/lansm-suspend-lautorisation-du-medicament-ifosfamide-eg
2020
false
false
false
France
French
pharmacovigilance note
Safety-Based drug withdrawals
ifosfamide
pharmaceutical solutions
brain diseases
---
https://ansm.sante.fr/informations-de-securite/acetate-dulipristal-esmya-ne-plus-utiliser-dans-lattente-des-conclusions-de-levaluation-europeenne-du-risque-hepatique
2020
false
false
false
France
French
risk assessment
pharmacovigilance note
ulipristal acetate
ulipristal
fibroid uterus
acute disease
Hepatitis fulminant
Safety-Based drug withdrawals
hepatitis, Drug-Induced
guidelines for drug use
hepatitis, Drug-Induced
signs and symptoms
leiomyoma
Chemical and Drug Induced Liver Injury
Chemical and Drug Induced Liver Injury
norpregnadienes
---
https://ansm.sante.fr/actualites/picato-mebutate-dingenol-suspension-de-lautorisation-de-mise-sur-le-marche-dans-lattente-des-conclusions-de-la-reevaluation-du-rapport-benefice-risque
2020
false
false
false
France
French
Safety-Based drug withdrawals
ingenol mebutate
pharmacovigilance note
administration, cutaneous
skin neoplasms
ingenol mebutate
keratosis, actinic
3-ingenyl angelate
diterpenes
---
PICATO (ingenol mebutate gel, 0.015% and 0.05%) - Product Withdrawal in Canada due
to Potential Increased Risk of Skin Cancer
https://canadiensensante.gc.ca/recall-alert-rappel-avis/hc-sc/2020/74193a-fra.php
2020
false
false
false
Canada
French
English
pharmacovigilance note
Safety-Based drug withdrawals
canada
ingenol mebutate
skin neoplasms
risk
ingenol mebutate
administration, cutaneous
keratosis, actinic
3-ingenyl angelate
diterpenes
---
https://www.ansm.sante.fr/actualites/picato-mebutate-dingenol-suspension-de-lautorisation-de-mise-sur-le-marche-dans-lattente-des-conclusions-de-la-reevaluation-du-rapport-benefice-risque
2020
false
false
false
France
French
Safety-Based drug withdrawals
ingenol mebutate
risk assessment
skin neoplasms
pharmacovigilance note
guidelines for drug use
administration, cutaneous
ingenol mebutate
carcinoma, squamous cell
keratosis, actinic
3-ingenyl angelate
diterpenes
---
https://www.ansm.sante.fr/actualites/rappel-des-medicaments-a-base-de-ranitidine-en-comprime-azantac-et-generiques-informations-pour-les-patients-et-les-professionnels-de-sante
2019
false
false
false
France
French
pharmacovigilance note
drug contamination
ranitidine
Safety-Based drug withdrawals
-
-
administration, oral
---
https://www.ansm.sante.fr/actualites/decontractyl-mephenesine-retrait-des-autorisations-de-mise-sur-le-marche-a-compter-du-28-juin-2019
2019
false
false
false
France
French
Safety-Based drug withdrawals
administration, oral
administration, cutaneous
mephenesin
muscle relaxants, central
contracture
musculoskeletal pain
---
https://ansm.sante.fr/informations-de-securite/mephenesine-decontractyl-r-500mg-comprime-enrobe-et-decontractyl-r-baume-pommade-retrait-des-autorisations-de-mise-sur-le-marche-le-28-juin-2019
2019
false
false
false
France
French
Safety-Based drug withdrawals
mephenesin
contracture
musculoskeletal pain
muscle relaxants, central
risk assessment
Drug Misuse
administration, oral
administration, cutaneous
pharmacovigilance note
---
https://ansm.sante.fr/informations-de-securite/fenspiride-pneumorel-80-mg-comprime-enrobe-et-pneumorel-0-2-pour-cent-sirop-suspension-des-autorisations-de-mise-sur-le-marche-le-8-fevrier-2019
2019
false
false
false
France
French
Safety-Based drug withdrawals
fenspiride hydrochloride
bronchodilator agents
arrhythmias, cardiac
fenspiride
administration, oral
cough
pharmacovigilance note
fenspiride
spiro compounds
---
Recalls and safety alerts mobile application
Application mobile sur les rappels et les avis de sécurité
https://www.canada.ca/en/services/health/stay-connected/recalls-safety-alerts-mobile-application.html
https://www.canada.ca/fr/services/sante/restez-branche/application-mobile-rappels-et-avis-securite.html
https://play.google.com/store/apps/details?id=com.tristan.healthcanada
https://apps.apple.com/fr/app/recalls-and-safety-alerts/id408663389?mt=8
https://is1-ssl.mzstatic.com/image/thumb/Purple123/v4/0b/3d/4a/0b3d4a21-b227-1f76-a0d8-9a895ab1e6b0/AppIcon-0-1x_U007emarketing-0-0-GLES2_U002c0-512MB-sRGB-0-0-0-85-220-0-0-0-10.png/230x0w.png
3.0.23
3.0.23
2020-06-11
2020-06-13
https://is4-ssl.mzstatic.com/image/thumb/Purple113/v4/02/be/74/02be745c-ed48-87e2-4385-a6fd6e9e5e24/pr_source.png/230x0w.png
https://is5-ssl.mzstatic.com/image/thumb/Purple123/v4/37/e7/97/37e79740-0216-567c-e8bb-ac9f7b7a6eb1/pr_source.png/230x0w.png
https://is4-ssl.mzstatic.com/image/thumb/Purple113/v4/38/c1/1d/38c11d01-010a-8aed-e06a-1f6eb7b7ee39/pr_source.png/230x0w.png
https://is4-ssl.mzstatic.com/image/thumb/Purple113/v4/ec/da/2d/ecda2d67-2d5b-3414-9882-4f275aa94eab/pr_source.png/230x0w.png
false
false
false
Safety-Based drug withdrawals
pharmacovigilance
canada
---
https://www.ansm.sante.fr/actualites/rappel-de-lots-de-medicaments-a-base-dirbesartan
2019
false
false
false
France
French
drug contamination
drugs, generic
diethylnitrosamine
Safety-Based drug withdrawals
pharmacovigilance note
hotlines
biphenyl compounds
tetrazoles
Irbesartan
---
https://canadiensensante.gc.ca/recall-alert-rappel-avis/hc-sc/2018/68448a-fra.php
2018
false
false
false
France
French
Valsartan
pharmacovigilance note
Safety-Based drug withdrawals
drug contamination
drugs, generic
canada
---
https://www.ansm.sante.fr/S-informer/Informations-de-securite-Lettres-aux-professionnels-de-sante/Ozurdex-R-700-microgrammes-implant-intravitreen-avec-applicateur-dexamethasone-recommandations-suite-a-la-detection-de-particule-de-silicone-sur-certains-implants-Lettre-aux-professionnels-de-sante
2018
false
false
false
France
French
drug implants
pharmacovigilance note
drug contamination
watchful waiting
Safety-Based drug withdrawals
guidelines for drug use
dexamethasone
Dexamethasone Intravitreal Implant
intravitreal injections
risk assessment
silicones
ocular inflammation
eye diseases
silicones
dexamethasone
---
https://www.ansm.sante.fr/actualites/arret-de-commercialisation-du-medicament-artotec-diclofenac-misoprostol
2018
false
false
false
France
French
pharmacovigilance note
Safety-Based drug withdrawals
Off-Label use
arthotec
hemorrhage
abortion, Drug-Induced
abortion, spontaneous
diclofenac, combinations
rheumatic diseases
abortion, induced
diclofenac
---
Teva Canada expands recall of valsartan drugs to include additional lots, as a precaution
https://canadiensensante.gc.ca/recall-alert-rappel-avis/hc-sc/2018/67552a-fra.php
2018
false
false
false
Canada
French
English
drugs, generic
Valsartan
pharmacovigilance note
Safety-Based drug withdrawals
drug contamination
canada
---
ZINBRYTA (daclizumab beta) - Voluntary Withdrawal in Canada due to Risk of Encephalitis
https://canadiensensante.gc.ca/recall-alert-rappel-avis/hc-sc/2018/66214a-fra.php
2018
false
false
false
Canada
French
English
pharmacovigilance note
Safety-Based drug withdrawals
risk
encephalitis
daclizumab
meningoencephalitis
meningoencephalitis
encephalitis
multiple sclerosis
guidelines for drug use
popular works
Chemical and Drug Induced Liver Injury
Zinbryta
Daclizumab
---
https://ansm.sante.fr/informations-de-securite/produits-de-contraste-a-base-de-gadolinium-et-retention-de-gadolinium-dans-le-cerveau-et-dans-dautres-tissus-suspension-des-amm-de-lacide-gadopentetique-et-du-gadodiamide-utilises-en-intraveineux-restriction-de-lamm-de-lacide-gadobenique-a-li
2018
false
false
false
France
French
pharmacovigilance note
Safety-Based drug withdrawals
gadolinium
contrast media
cerebrum
gadobenic acid
gadolinium DTPA
injections, intravenous
injections, Intra-Articular
gadobenic acid
gadopentetic acid
gadodiamide
gadodiamide
organometallic compounds
meglumine
meglumine
---
https://ansm.sante.fr/actualites/Nouveau-rappel-de-medicaments-a-base-de-valsartan-Informations-pour-les-patients-et-les-professionnels-de-sante
2018
false
false
false
false
France
French
guidelines for drug use
Valsartan
Valsartan
drug combinations
hydrochlorothiazide
administration, oral
drug contamination
patients guideline
valsartan
valsartan and diuretics
Safety-Based drug withdrawals
---
Recalls and safety alerts mobile application
https://www.canada.ca/fr/services/sante/restez-branche/application-mobile-rappels-et-avis-securite.html
https://www.canada.ca/en/services/health/stay-connected/recalls-safety-alerts-mobile-application.html
https://play.google.com/store/apps/details?id=com.tristan.healthcanada
https://apps.apple.com/fr/app/recalls-and-safety-alerts/id408663389?mt=8
2017
false
false
false
Canada
French
English
mobile application
pharmacovigilance
Safety-Based drug withdrawals
canada
---
https://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2013/34783a-fra.php
2013
Canada
French
English
Safety-Based drug withdrawals
salmon calcitonin
administration, intranasal
nasal sprays
calcitonin (salmon synthetic)
osteoporosis, postmenopausal
neoplasms
bone density conservation agents
pharmacovigilance note
calcitonin
---
http://www.ssmg.be/images/ssmg/files/RMG/306/RMG306_34-41.pdf
2013
Belgium
French
journal article
tetrazepam
benzodiazepines
muscle relaxants, central
low back pain
Evidence-Based medicine
Safety-Based drug withdrawals
general practice
general practitioners
---
https://www.healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2011/14093a-fra.php
https://www.healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2011/14633a-fra.php
2011
Canada
English
French
Cardiotoxicity
adult
dolasetron
arrhythmias, cardiac
Safety-Based drug withdrawals
canada
indoles
quinolizines
injections, intravenous
dolasetron
antiemetics
pharmacovigilance note
patient education handout
Product containing dolasetron in parenteral dose form (medicinal product form)
---
https://ansm.sante.fr/uploads/2021/03/11/991ba07542cf2721a4ce1f46e6217894.pdf
2011
false
France
French
practice guideline
drug information
Therapy cessation
Safety-Based drug withdrawals
hypnotics and sedatives
sleep initiation and maintenance disorders
Noctran
drug combinations
mepronizine
---
https://www.healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2010/14614a-fra.php
https://www.healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2010/13438a-fra.php
2010
Canada
French
English
canada
sibutramine
cyclobutanes
appetite depressants
sibutramine
Safety-Based drug withdrawals
risk assessment
cardiovascular diseases
cyclobutanes
pharmacovigilance note
---
https://www.healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2010/14597a-fra.php
https://www.healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2010/16115a-fra.php
2010
Canada
English
French
Cardiotoxicity
canada
dextropropoxyphene
Safety-Based drug withdrawals
analgesics, opioid
dextropropoxyphene
arrhythmias, cardiac
pharmacovigilance note
patient education handout
---
https://www.healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2010/16113a-fra.php
https://www.healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2010/14627a-fra.php
2010
Canada
French
English
sitaxsentan
orphan drug production
Safety-Based drug withdrawals
hypertension, pulmonary
administration, oral
sitaxentan
thiophenes
isoxazoles
receptors, endothelin
liver diseases
isoxazoles
thiophenes
pharmacovigilance note
patient education handout
---