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MedEffect Canada safety and effectiveness reviews - Canada.ca

18 avr. 2025

legacy-hc-2025-04-21

ID 211694

Capture suivante

MedEffect Canada safety and effectiveness reviews for health products - Canada.ca

2 janv. 2026

hc-20260101

ID 428937

updated1 sections changed; 1 added; 1 removed
1 sections modifiées1 ajoutées1 retirées+145 / -80 lignesVariation: 14%
---
+++
@@ -1,12 +1,117 @@
-New safety and effectiveness reviews
+New safety and effectiveness reviews for health products
The following tables list the safety and effectiveness reviews that were started by Health Canada during the identified period. The appearance of a health product in these tables means that Health Canada has identified a potential safety issue, through
surveillance
, but it does not mean that Health Canada has identified a causal relationship between the health product and the listed risk.
Once a safety and effectiveness review is completed, a
summary safety review
is published to inform Canadians of what was found and what action was taken by Health Canada, if any.
-No safety and effectiveness reviews initiated from 2025‑01‑01 to 2025‑01‑31
-No safety and effectiveness reviews initiated from 2024‑12‑01 to 2024‑12‑31
+List of Safety and Effectiveness Reviews Initiated from 2025-10-01 to 2025-10-31
+Brand Name and / or Product Class / Medical Device(s)
+Medicinal Ingredient(s)
+Potential Safety Issue
+Trigger
+Ozempic, Rybelsus, Wegovy
+Semaglutide
+Non-arteritic anterior ischemic optic neuropathy (NAION) (sudden vision loss or changes caused by reduced blood flow to the optic nerve)
+Scientific literature
+Calcitonin gene-related peptide (CGRP) receptor inhibitors (Aimovig, Ajovy, Emgality, Nurtec ODT, Qulipta, Ubrelvy, Vyepti)
+Erenumab, fremanezumab, galcanezumab, rimegepant, atogepant, ubrogepant, eptinezumab
+Raynaud’s phenomenon (a disorder that causes some areas of the body to feel numb and cold as a result of limited blood flow to the affected areas)
+Foreign agency - U.S. Food and Drug Administration (US FDA)
+Tramadol-containing products
+Tramadol hydrochloride
+Hiccups lasting more than several hours
+Case reports
+Ciprofloxacin-containing products
+Ciprofloxacin
+Syndrome of inappropriate antidiuretic hormone secretion (SIADH, a condition in which the body makes too much antidiuretic hormone, leading to more water being held in the body) and hyponatremia (low blood sodium levels)
+Foreign agency - European Medicines Agency (EMA)
+List of Safety and Effectiveness Reviews Initiated from 2025-09-01 to 2025-09-30
+Brand Name and / or Product Class / Medical Device(s)
+Medicinal Ingredient(s)
+Potential Safety Issue
+Trigger
+Ashwagandha-containing products
+Withania somnifera
+Hepatotoxicity (liver injury)
+Scientific literature
+Clozapine-containing products
+Clozapine
+Hematologic (blood) cancer
+Foreign agency - European Medicines Agency (EMA)
+Clozapine-containing products
+Clozapine
+Effectiveness of the monitoring measures for low numbers of white blood cells
+Foreign agencies - U.S. Food and Drug Administration (US FDA) and European Medicines Agency (EMA)
+No safety and effectiveness reviews initiated from 2025-08-01 to 2025-08-31
+List of Safety and Effectiveness Reviews Initiated from 2025-07-01 to 2025-07-31
+Brand Name and / or Product Class / Medical Device(s)
+Medicinal Ingredient(s)
+Potential Safety Issue
+Trigger
+Bortezomib-containing products
+Bortezomib (bortezomib mannitol boronic ester)
+Drug reaction with eosinophilia and systemic symptoms (DRESS) (a type of allergic drug reaction with rash, fever, increased white blood cell count, and injury to one or more organs)
+Drug manufacturer (Notification of Foreign Action)
+Finasteride-containing products
+Dutasteride-containing products
+Finasteride
+Dutasteride
+Suicidal ideation (thoughts of suicide)
+Foreign agency - European Medicines Agency (EMA)
+Finasteride-containing products
+Dutasteride-containing products
+Finasteride
+Dutasteride
+Sexual dysfunction
+Case reports and scientific literature
+No safety and effectiveness reviews initiated from 2025-06-01 to 2025-06-30
+List of Safety and Effectiveness Reviews Initiated from 2025-05-01 to 2025-05-31
+Brand Name and / or Product Class / Medical Device(s)
+Medicinal Ingredient(s)
+Potential Safety Issue
+Trigger
+Hemovel
+Diosmin
+Bleeding
+Case report
+List of Safety and Effectiveness Reviews Initiated from 2025-04-01 to 2025-04-30
+Brand Name and / or Product Class / Medical Device(s)
+Medicinal Ingredient(s)
+Potential Safety Issue
+Trigger
+Givlaari
+Givosiran
+Acute pancreatitis (sudden inflammation of the pancreas)
+Drug manufacturer (Notification of Foreign Action) Foreign agency - U.S. Food and Drug Administration (US FDA)
+Rylaze
+Crisantaspase
+Hepatic veno-occlusive disease (a condition where small veins in the liver become blocked)
+Drug manufacturer (Notification of Foreign Action)
+List of Safety and Effectiveness Reviews Initiated from 2025-03-01 to 2025-03-31
+Brand Name and / or Product Class / Medical Device(s)
+Medicinal Ingredient(s)
+Potential Safety Issue
+Trigger
+Imbruvica, Calquence, Brukinsa (BTK [Bruton's tyrosine kinase] inhibitors)
+Ibrutinib, acalabrutinib, zanubrutinib
+Serious liver injury
+Drug manufacturer (Notification of Foreign Action)
+List of Safety and Effectiveness Reviews Initiated from 2025-02-01 to 2025-02-28
+Brand Name and / or Product Class / Medical Device(s)
+Medicinal Ingredient(s)
+Potential Safety Issue
+Trigger
+Etibi
+Ethambutol hydrochloride
+Drug reaction with eosinophilia and systemic symptoms (DRESS) (a type of allergic drug reaction with rash, fever, increased white blood cell count, and injury to one or more organs)
+Foreign agency - European Medicines Agency (EMA)
+Dimethyl fumarate-containing products
+Dimethyl fumarate
+Gastrointestinal adverse events, including perforation (hole in the wall of the gastrointestinal tract), ulceration (open sore on the lining of the gastrointestinal tract), hemorrhage (bleeding in the gastrointestinal tract) and obstruction (blockage of the gastrointestinal tract)
+Foreign agency - U.S. Food and Drug Administration (US FDA)
+No safety and effectiveness reviews initiated from 2025-01-01 to 2025-01-31
+No safety and effectiveness reviews initiated from 2024-12-01 to 2024-12-31
List of Safety and Effectiveness Reviews Initiated from 2024-11-01 to 2024-11-30
Brand Name and / or Product Class / Medical Device(s)
Medicinal Ingredient(s)
@@ -32,8 +137,7 @@
Scientific literature
No safety and effectiveness reviews initiated from 2024-08-01 to 2024-08-31
List of Safety and Effectiveness Reviews Initiated from 2024-07-01 to 2024-07-31
-Brand Name and / or
-Product Class /
+Brand Name and / or Product Class /
Medical Device(s)
Medicinal Ingredient(s)
Potential Safety Issue
@@ -43,9 +147,7 @@
Hepatotoxicity (liver injury)
Foreign agency - Australian Therapeutic Goods Administration (TGA)
List of Safety and Effectiveness Reviews Initiated from 2024-06-01 to 2024-06-30
-Brand Name and / or
-Product Class /
-Medical Device(s)
+Brand Name and / or Product Class / Medical Device(s)
Medicinal Ingredient(s)
Potential Safety Issue
Trigger
@@ -62,9 +164,7 @@
Pulmonary edema (build up of fluid in the lungs) in patients with pulmonary veno-occlusive disease (condition characterized by the blockage of the blood vessels that carry blood from the lungs to the heart)
Case reports
List of Safety and Effectiveness Reviews Initiated from 2024-05-01 to 2024-05-31
-Brand Name and / or
-Product Class /
-Medical Device(s)
+Brand Name and / or Product Class / Medical Device(s)
Medicinal Ingredient(s)
Potential Safety Issue
Trigger
@@ -74,37 +174,31 @@
Foreign agency - U.S. Food and Drug Administration (US FDA)
No safety and effectiveness reviews initiated from 2024-04-01 to 2024-04-30
List of Safety and Effectiveness Reviews Initiated from 2024-03-01 to 2024-03-31
-Brand Name and / or
-Product Class /
-Medical Device(s)
+Brand Name and / or Product Class / Medical Device(s)
Medicinal Ingredient(s)
Potential Safety Issue
Trigger
Breyanzi, Tecartus, Kymriah, Yescarta, Carvykti
Lisocabtagene maraleucel, brexucabtagene autoleucel, tisagenlecleucel, axicabtagene ciloleucel, ciltacabtagene autoleucel
T-cell malignancy (cancer that forms in white blood cells called T cells)
-Foreign agency – U.S. Food and Drug Administration (US FDA)
+Foreign agency - U.S. Food and Drug Administration (US FDA)
Stivarga
Regorafenib
Thrombotic microangiopathy (blood clotting disorder affecting small blood vessels)
-Foreign agency – European Medicines Agency (EMA)
+Foreign agency - European Medicines Agency (EMA)
List of Safety and Effectiveness Reviews Initiated from 2024-02-01 to 2024-02-29
-Brand Name and / or
-Product Class /
-Medical Device(s)
+Brand Name and / or Product Class / Medical Device(s)
Medicinal Ingredient(s)
Potential Safety Issue
Trigger
Direct oral anticoagulants and warfarin-containing products
Rivaroxaban, dabigatran, apixaban, edoxaban, warfarin
-Splenic rupture (tear in the spleen’s surface)
+Splenic rupture (tear in the spleen's surface)
Signal identification from foreign agency
No safety and effectiveness reviews initiated from 2024-01-01 to 2024-01-31
No safety and effectiveness reviews initiated from 2023-12-01 to 2023-12-31
List of Safety and Effectiveness Reviews Initiated from 2023-11-01 to 2023-11-30
-Brand Name and / or
-Product Class /
-Medical Device(s)
+Brand Name and / or Product Class / Medical Device(s)
Medicinal Ingredient(s)
Potential Safety Issue
Trigger
@@ -140,9 +234,7 @@
Drug manufacturer (Notification of Foreign Action)
No safety and effectiveness reviews initiated from 2023-08-01 to 2023-08-31
List of Safety and Effectiveness Reviews Initiated from 2023-07-01 to 2023-07-31
-Brand Name and / or
-Product Class /
-Medical Device(s)
+Brand Name and / or Product Class / Medical Device(s)
Medicinal Ingredient(s)
Potential Safety Issue
Trigger
@@ -163,9 +255,7 @@
Hypothyroidism (abnormally low activity of the thyroid gland) in children up to 3 years of age
Foreign agency - U.S. Food and Drug Administration (US FDA)
List of Safety and Effectiveness Reviews Initiated from 2023-06-01 to 2023-06-30
-Brand Name and / or
-Product Class /
-Medical Device(s)
+Brand Name and / or Product Class / Medical Device(s)
Medicinal Ingredient(s)
Potential Safety Issue
Trigger
@@ -195,7 +285,7 @@
Amiodarone-containing products
Amiodarone hydrochloride
Primary graft dysfunction (impaired function of the heart occurring within 24 hours after heart transplantation)
-Foreign agency – Medicines and Healthcare products Regulatory Agency (MHRA)
+Foreign agency - Medicines and Healthcare products Regulatory Agency (MHRA)
No safety and effectiveness reviews initiated from 2023-03-01 to 2023-03-31
No safety and effectiveness reviews initiated from 2023-02-01 to 2023-02-28
No safety and effectiveness reviews initiated from 2023-01-01 to 2023-01-31
@@ -517,8 +607,7 @@
Health Canada review of routine safety reports from the manufacturer
List of Safety and Effectiveness Reviews Initiated from 2020-07-01 to 2020-07-31
Brand Name and / or Product Class / Medical Device(s)
-Medicinal
-Ingredient(s)
+Medicinal Ingredient(s)
Potential Safety Issue
Trigger
Dopamine Agonists:
@@ -647,10 +736,8 @@
Autoimmune hemolytic anemia (disease when the body's immune system attacks and destroys its own red blood cells)
Health Canada's review of a Post-market Decision Letter
List of Safety and Effectiveness Reviews Initiated from 2019-12-01 to 2019-12-31
-Brand Name and / or Product Class /
-Medical Device(s)
-Medicinal
-Ingredient(s)
+Brand Name and / or Product Class / Medical Device(s)
+Medicinal Ingredient(s)
Potential Safety Issue
Trigger
Maviret
@@ -674,10 +761,8 @@
Central sleep apnea (disease when breathing repeatedly stops and starts during sleep).
Scientific literature
List of Safety and Effectiveness Reviews Initiated from 2019-11-01 to 2019-11-30
-Brand Name and / or Product Class /
-Medical Device(s)
-Medicinal
-Ingredient(s)
+Brand Name and / or Product Class / Medical Device(s)
+Medicinal Ingredient(s)
Potential Safety Issue
Trigger
Tamiflu
@@ -685,10 +770,8 @@
Haemorrhage (bleeding) / major bleeding events
Foreign agency - Pharmaceuticals and Medical Devices Agency, Japan
List of Safety and Effectiveness Reviews Initiated from 2019-10-01 to 2019-10-31
-Brand Name and / or Product Class /
-Medical Device(s)
-Medicinal
-Ingredient(s)
+Brand Name and / or Product Class / Medical Device(s)
+Medicinal Ingredient(s)
Potential Safety Issue
Trigger
Antibiotic bone cements and cement spacers
@@ -696,10 +779,8 @@
Nephrotoxicity (kidneys toxicity)
Scientific literature
List of Safety and Effectiveness Reviews Initiated from 2019-09-01 to 2019-09-30
-Brand Name and / or Product Class /
-Medical Device(s)
-Medicinal
-Ingredient(s)
+Brand Name and / or Product Class / Medical Device(s)
+Medicinal Ingredient(s)
Potential Safety Issue
Trigger
Mesalazine-containing products
@@ -712,10 +793,8 @@
Second-and third-degree atrioventricular block (partial or complete block in the transmission of heart impulses)
Request from the Therapeutic Products Directorate, Health Canada
List of Safety and Effectiveness Reviews Initiated from 2019-08-01 to 2019-08-31
-Brand Name and / or Product Class /
-Medical Device(s)
-Medicinal
-Ingredient(s)
+Brand Name and / or Product Class / Medical Device(s)
+Medicinal Ingredient(s)
Potential Safety Issue
Trigger
Hydromorph Contin and generic hydromorphone controlled release capsules products
@@ -738,10 +817,8 @@
No safety and effectiveness reviews initiated from 2019-06-01 to 2019-06-30
No safety and effectiveness reviews initiated from 2019-05-01 to 2019-05-31
List of Safety and Effectiveness Reviews Initiated from 2019-04-01 to 2019-04-30
-Brand Name and / or Product Class /
-Medical Device(s)
-Medicinal
-Ingredient(s)
+Brand Name and / or Product Class / Medical Device(s)
+Medicinal Ingredient(s)
Potential Safety Issue
Trigger
Imodium
@@ -757,10 +834,8 @@
Venous Thromboembolic (blood clotting that starts in the vein) events (deep venous thrombosis [DVT] and pulmonary embolism [PE] (blood clots in the lungs))
Drug manufacturer (information from an ongoing study)
List of Safety and Effectiveness Reviews Initiated from 2019-03-01 to 2019-03-31
-Brand Name and / or Product Class /
-Medical Device(s)
-Medicinal
-Ingredient(s)
+Brand Name and / or Product Class / Medical Device(s)
+Medicinal Ingredient(s)
Potential Safety Issue
Trigger
Imfinzi
@@ -776,10 +851,8 @@
Connective tissue, rheumatic, and autoimmune disease (when the immune system attacks its own tissues)
Publication
List of Safety and Effectiveness Reviews Initiated from 2019-02-01 to 2019-02-28
-Brand Name and / or Product Class /
-Medical Device(s)
-Medicinal
-Ingredient(s)
+Brand Name and / or Product Class / Medical Device(s)
+Medicinal Ingredient(s)
Potential Safety Issue
Trigger
Daklinza
@@ -808,10 +881,8 @@
Dysglycaemia (abnormality in blood sugar stability - can include low blood sugar or high blood sugar.
European Medicines Agency Assessment
List of Safety and Effectiveness Reviews Initiated from 2019-01-01 to 2019-01-31
-Brand Name and / or Product Class /
-Medical Device(s)
-Medicinal
-Ingredient(s)
+Brand Name and / or Product Class / Medical Device(s)
+Medicinal Ingredient(s)
Potential Safety Issue
Trigger
Tapazole mar-methimazole
@@ -819,10 +890,8 @@
Pancreatitis (inflammation of the pancreas)
European Medicines Agency Assessment
List of Safety and Effectiveness Reviews Initiated from 2018-12-01 to 2018-12-31
-Brand Name and / or Product Class /
-Medical Device(s)
-Medicinal
-Ingredient(s)
+Brand Name and / or Product Class / Medical Device(s)
+Medicinal Ingredient(s)
Potential Safety Issue
Trigger
Daklinza
@@ -849,10 +918,8 @@
Hepatocellular carcinoma (liver cancer)
Follow up to previous review completed in 2016
List of Safety and Effectiveness Reviews Initiated from 2018-11-01 to 2018-11-30
-Brand Name and / or Product Class /
-Medical Device(s)
-Medicinal
-Ingredient(s)
+Brand Name and / or Product Class / Medical Device(s)
+Medicinal Ingredient(s)
Potential Safety Issue
Trigger
Selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs)
@@ -886,10 +953,8 @@
Breast implants linked to anaplastic large cell lymphoma - BIA-ALCL (rare type of blood cancer)
Many articles and foreign agency notices
List of Safety and Effectiveness Reviews Initiated from 2018-10-01 to 2018-10-31
-Brand Name and / or Product Class /
-Medical Device(s)
-Medicinal
-Ingredient(s)
+Brand Name and / or Product Class / Medical Device(s)
+Medicinal Ingredient(s)
Potential Safety Issue
Trigger
Systemic fluroquinolone antibiotics
@@ -940,10 +1005,8 @@
Fraying (wearing away) leading to increased risks of toxic shock syndrome and related symptoms
Case Report
List of Safety and Effectiveness Reviews Initiated from 2018-09-01 to 2018-09-30

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