New safety and effectiveness reviews

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 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)
Medicinal Ingredient(s) Potential Safety Issue Trigger
Glucagon-like peptide-1 receptor agonists (GLP-1 RA) Semaglutide, liraglutide, insulin degludec plus liraglutide, dulaglutide, lixisenatide, insulin glargine plus lixisenatide, exenatide Suicide, self-harm, suicidal ideation (thoughts of suicide) and self-injurious ideation (thoughts of self-harm) Foreign agency - European Medicines Agency (EMA)
Ilaris Canakinumab 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) Health Canada review of routine safety reports from the manufacturer
HMG-CoA reductase inhibitors (statins) Atorvastatin, lovastatin, rosuvastatin, simvastatin, pravastatin, fluvastatin Myasthenia gravis, including ocular myasthenia (a neuromuscular condition that causes weakness of the voluntary muscles of the body, including those that control the eyes and eyelids) Foreign agency - European Medicines Agency (EMA)
Accutane Roche, Clarus, Epuris, Absorica LD Isotretinoin Sacroiliitis (inflammation of the sacroiliac joints [where the spine meets the pelvis], usually resulting in pain) Drug manufacturer (Notification of Foreign Action)

No safety and effectiveness reviews initiated from 2023-10-01 to 2023-10-31

List of Safety and Effectiveness Reviews Initiated from 2023-09-01 to 2023-09-30
Brand Name and / or Product Class / Medical Device(s) Medicinal Ingredient(s) Potential Safety Issue Trigger
Systemic (by injection or by mouth) cyclosporine- containing products Cyclosporine Hearing impairment Drug manufacturer (Notification of Foreign Action)
Dasatinib-containing products Dasatinib Delayed growth 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)
Medicinal Ingredient(s) Potential Safety Issue Trigger
Zyprexa Olanzapine Syndrome of inappropriate secretion of antidiuretic hormone (SIADH, a condition in which the body makes too much antidiuretic hormone,  leading to more water being held in the body and low blood sodium level)

Health Canada review of a manufacturer safety report

Nexavar Sorafenib tosylate Tumour lysis syndrome (quick cancer cells breakdown severely affecting many organs) Foreign agency - European Medicines Agency (EMA)
Jardiance, Synjardy, Xigduo, Forxiga, Invokana, Invokamet (SGLT2 inhibitors) Empagliflozin, dapagliflozin, canagliflozin Prolonged or new-onset diabetic ketoacidosis (high levels of acids in the blood) after stopping SGLT2 inhibitors Request from the Pharmaceuticals Drug Directorate, Health Canada
Iodine contrast agents Diatrizoate, iopamidol, ioversol, iothalamate, iodixanol, iohexol, iopromide, iodine (ethiodized oil) 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)
Medicinal Ingredient(s) Potential Safety Issue Trigger
Isotretinoin-containing products Isotretinoin Sexual dysfunction, including ongoing sexual dysfunction after stopping the use of the drug

Foreign agency - Medicines and Healthcare products

Regulatory Agency (MHRA)

List of Safety and Effectiveness Reviews Initiated from 2023-05-01 to 2023-05-31
Brand Name and / or Product Class / Medical Device(s) Medicinal Ingredient(s) Potential Safety Issue Trigger
Neulasta Pegfilgrastim Stevens-Johnson syndrome (disorder of the skin and mucous membranes) and toxic epidermal necrolysis (severe form of Stevens-Johnson syndrome) Review of Periodic Benefit-Risk Evaluation Report
Coly-Mycin M Colistin (colistimethate sodium) Pseudo-Bartter syndrome (an acid-base and electrolyte imbalance) Scientific literature
List of Safety and Effectiveness Reviews Initiated from 2023-04-01 to 2023-04-30
Brand Name and / or Product Class / Medical Device(s) Medicinal Ingredient(s) Potential Safety Issue Trigger
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)

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

List of Safety and Effectiveness Reviews Initiated from 2022-12-01 to 2022-12-31
Brand Name and / or Product Class / Medical Device(s) Medicinal Ingredient(s) Potential Safety Issue Trigger
Tecfidera Dimethyl fumarate Fanconi syndrome (disorder of the kidneys) Foreign Agency - European Medicines Agency (EMA)
Domperidone-containing products Domperidone Drug withdrawal symptoms after stopping or reducing the dose of domperidone used to stimulate lactation Case reports

No safety and effectiveness reviews initiated from 2022-11-01 to 2022-11-30

List of Safety and Effectiveness Reviews Initiated from 2022-10-01 to 2022-10-31
Brand Name and / or Product Class / Medical Device(s) Medicinal Ingredient(s) Potential Safety Issue Trigger

Tagrisso

Osimertinib mesylate

Rhabdomyolysis (muscle breakdown) and myopathy (disorders of muscle)

Foreign agency - U.S. Food and Drug Administration (US FDA)

List of Safety and Effectiveness Reviews Initiated from 2022-09-01 to 2022-09-30
Brand Name and / or Product Class / Medical Device(s) Medicinal Ingredient(s) Potential Safety Issue Trigger

Keytruda

Tecentriq

Pembrolizumab

Atezolizumab

Aplastic anemia (disease when the body stops producing enough new blood cells) Scientific literature and Health Canada review of routine safety reports from the manufacturer

No safety and effectiveness reviews initiated from 2022-08-01 to 2022-08-31

List of Safety and Effectiveness Reviews Initiated from 2022-07-01 to 2022-07-31
Brand Name and / or Product Class / Medical Device(s) Medicinal Ingredient(s) Potential Safety Issue Trigger
Magec Spinal Bracing and Distraction System N/A Distraction failure (failure to lengthen the rod to account for the child's growth) and generation of metal wear debris Scientific literature
List of Safety and Effectiveness Reviews Initiated from 2022-06-01 to 2022-06-30
Brand Name and / or Product Class / Medical Device(s) Medicinal Ingredient(s) Potential Safety Issue Trigger
Soliris Eculizumab Hepatotoxicity (liver injury) Case reports and scientific literature
List of Safety and Effectiveness Reviews Initiated from 2022-05-01 to 2022-05-31
Brand Name and / or Product Class / Medical Device(s) Medicinal Ingredient(s) Potential Safety Issue Trigger
Isolette infant incubator N/A Risk of falls Incident report
Combination sulfamethoxazole and trimethoprim-containing products Sulfamethoxazole and trimethoprim Hemophagocytic lymphohistiocytosis (HLH, an excessive activation of white blood cells [cells that fight infections] associated with inflammation) Foreign agency - European Medicines Agency (EMA)

No safety and effectiveness reviews initiated from 2022-04-01 to 2022-04-30

List of Safety and Effectiveness Reviews Initiated from 2022-03-01 to 2022-03-31
Brand Name and / or Product Class / Medical Device(s) Medicinal Ingredient(s) Potential Safety Issue Trigger
Mercaptopurine-containing products Mercaptopurine Hypoglycemia (low blood sugar) Foreign agency - U.S. Food and Drug Administration (US FDA)
List of Safety and Effectiveness Reviews Initiated from 2022-02-01 to 2022-02-28
Brand Name and / or Product Class / Medical Device(s) Medicinal Ingredient(s) Potential Safety Issue Trigger
Proglycem Diazoxide Neonatal necrotizing enterocolitis (inflammation and death of tissue in a newborn's bowel walls) Case reports
List of Safety and Effectiveness Reviews Initiated from 2022-01-01 to 2022-01-31
Brand Name and / or Product Class / Medical Device(s) Medicinal Ingredient(s) Potential Safety Issue Trigger
Ibrance Palbociclib Venous thromboembolic events (blood clots that form in a deep vein) Scientific literature
Systemic (by injection or by mouth) cloxacillin-containing products Cloxacillin sodium Acute (sudden) kidney injury Case reports and Foreign agency - Agence nationale de sécurité du médicament et des produits de santé (France)

No safety and effectiveness reviews initiated from 2021-12-01 to 2021-12-31

List of Safety and Effectiveness Reviews Initiated from 2021-11-01 to 2021-11-30
Brand Name and / or Product Class / Medical Device(s) Medicinal Ingredient(s) Potential Safety Issue Trigger
Nexavar Sorafenib Thrombotic microangiopathy (blood clotting disorder affecting small blood vessels) Foreign agency - U.S. Food and Drug Administration (US FDA) and case reports
List of Safety and Effectiveness Reviews Initiated from 2021-10-01 to 2021-10-31
Brand Name and / or Product Class / Medical Device(s) Medicinal Ingredient(s) Potential Safety Issue Trigger
Olumiant,
Rinvoq,
Xeljanz, Xeljanz XR
Baricitinib,
Upadacitinib,
Tofacitinib
Major Adverse Cardiovascular Events (MACE, serious heart-related problems), malignancy (cancer), and thrombosis (blood clots) Follow-up to a previous review completed in 2021
Proglycem Diazoxide Pericardial effusion (accumulation of fluid around the heart) Scientific literature
Cephalosporins Cephalexin,
Cefazolin,
Cefadroxil,
Cefoxitin,
Cefuroxime,
Cefprozil,
Cefotaxime,
Ceftazidime,
Ceftriaxone,
Cefixime,
Cefepime,
Ceftobiprole,
Ceftolozane/ Tazobactam
Seizures Foreign agency - U.S. Food and Drug Administration (US FDA)
Finasteride-containing products Finasteride Suicide, suicidal ideation (suicidal thoughts and/or behaviour) and self injury Follow-up to a previous review completed in 2018

No safety and effectiveness reviews initiated from 2021-09-01 to 2021-09-30

List of Safety and Effectiveness Reviews Initiated from 2021-08-01 to 2021-08-31
Brand Name and / or Product Class / Medical Device(s) Medicinal Ingredient(s) Potential Safety Issue Trigger

Donepezil-containing products

Galantamine-containing products

Rivastigmine-containing products

Donepezil hydrochloride

Galantamine

Rivastigmine

QT interval prolongation and torsade de pointes (serious abnormal heart rhythm caused by abnormal electrical activity in the lower chambers of the heart) Foreign Agency - European Medicines Agency (EMA)
Sevoflurane-containing products Sevoflurane Nephrogenic diabetes insipidus (inability of the kidneys to respond to the hormone that regulates fluid balance [antidiuretic hormone], causing an imbalance of body water content, and leading to the production of large amounts of dilute urine) Scientific literature

No safety and effectiveness reviews initiated from 2021-07-01 to 2021-07-31

List of Safety and Effectiveness Reviews Initiated from 2021-06-01 to 2021-06-30
Brand Name and / or Product Class / Medical Device(s) Medicinal Ingredient(s) Potential Safety Issue Trigger
Methadone-containing products Methadone hydrochloride Hypoglycemia (low blood sugar) Scientific literature
List of Safety and Effectiveness Reviews Initiated from 2021-05-01 to 2021-05-31
Brand Name and / or Product Class / Medical Device(s) Medicinal Ingredient(s) Potential Safety Issue Trigger
Domperidone-containing products Domperidone Serious ventricular arrhythmias and QT interval prolongation (serious abnormal heart rhythm caused by abnormal electrical activity in the lower chambers of the heart), sudden cardiac arrest (sudden loss of heart function), and sudden cardiac death (sudden death) Follow-up to a safety review completed in 2014, and 2021 study results from the Canadian Network for Observational Drug Effect Studies (CNODES)
List of Safety and Effectiveness Reviews Initiated from 2021-04-01 to 2021-04-30
Brand Name and / or
Product Class / Medical
Device(s)
Medicinal Ingredient(s) Potential Safety Issue Trigger

Aromatase inhibitors:

Letrozole-containing products
Anastrozole-containing products
Exemestane-containing products

Letrozole

Anastrozole

Exemestane

Tendonitis (inflammation of any tendon), Tendon rupture (complete or partial tear of any tendon) Foreign Agency - European Medicines Agency (EMA)
Valacyclovir-containing products Valacyclovir Drug rash with eosinophilia and systemic symptoms (DRESS) syndrome (drug allergy reaction that results in rash, high white blood cell count, and affects one or more organs) Drug manufacturer (Notification of Foreign Action)
Janssen COVID-19 Vaccine Ad26.COV2.S (recombinant) Thrombosis (blood clots) in combination with thrombocytopenia (low blood platelets) U.S. case reports
List of Safety and Effectiveness Reviews Initiated from 2021-03-01 to 2021-03-31
Brand Name and / or Product Class / Medical Device(s) Medicinal Ingredient(s) Potential Safety Issue Trigger
Amoxicillin (alone or in combination) Amoxicillin Aseptic meningitis (inflammation of the linings covering the brain and spinal cord without an infectious cause) Scientific literature
  • Xeljanz,
  • Xeljanz XR
Tofacitinib Major Adverse Cardiovascular Events (MACE, serious heart-related problems) Drug manufacturer (information from a clinical trial)
  • Xeljanz,
  • Xeljanz XR
Tofacitinib Malignancy (cancer) Drug manufacturer (information from a clinical trial)
  • Avastin
  • Cyramza
  • Bevacizumab
  • Ramucirumab
  • Arterial aneurysm (balloon-like bulge in the wall of a blood vessel [artery])
  • Arterial dissection (separation of the layers of a blood vessel [artery])
  • Aneurysm rupture (aneurysm that is leaking or has burst open)
Foreign Agency- The U.S. Food and Drug Administration (US FDA)
  • AstraZeneca COVID-19 Vaccine
  • COVISHIELD
ChAdOx1-S (recombinant) Thrombosis (blood clots) in combination with thrombocytopenia (low blood platelets) Case reports
  • No safety and effectiveness reviews initiated from 2021-02-01 to 2021-02-28
  • No safety and effectiveness reviews initiated from 2021-01-01 to 2021-01-31
List of Safety and Effectiveness Reviews Initiated from 2020-12-01 to 2020-12-31
Brand Name and / or Product Class / Medical Device(s) Medicinal Ingredient(s) Potential Safety Issue Trigger
Vanch Disposable Medical Mask N/A Local irritation and hypersensitivity (allergic reactions) Case reports
List of Safety and Effectiveness Reviews Initiated from 2020-11-01 to 2020-11-30
Brand Name and / or Product Class / Medical Device(s) Medicinal Ingredient(s) Potential Safety Issue Trigger
Systemic (by injection or by mouth) and inhaled (breathed in) fluoroquinolone antibiotics
  • Ciprofloxacin
  • Levofloxacin
  • Moxifloxacin
  • Norfloxacin
Heart regurgitation (leaking heart valves) Foreign Agency - European Medicines Agency (EMA)
Aimovig Erenumab Cardiac (heart related) events Health Canada review of routine safety and efficacy information from the manufacturer
List of Safety and Effectiveness Reviews Initiated from 2020-10-01 to 2020-10-31
Brand Name and / or Product Class / Medical Device(s) Medicinal Ingredient(s) Potential Safety Issue Trigger
Veklury Remdesivir Acute (sudden) kidney injury Foreign agency - European Medicines Agency (EMA)
List of Safety and Effectiveness Reviews Initiated from 2020-09-01 to 2020-09-30
Brand Name and / or Product Class / Medical Device(s) Medicinal Ingredient(s) Potential Safety Issue Trigger

Gadolinium-Based Contrast Agents:

  • MultiHance
  • Gadovist 1.0
  • Dotarem
  • Magnevist
  • Gadopentetate dimeglumine injection
  • Gadopentetate dimeglumine injection, USP
  • ProHance
  • Omniscan
  • Primovist
  • Gadobenate dimeglumine
  • Gadobutrol
  • Gadoterate meglumine
  • Gadopentetate dimeglumine
  • Gadopentetate dimeglumine
  • Gadopentetate dimeglumine
  • Gadoteridol
  • Gadodiamide
  • Gadoxetate disodium
Risk of birth defects, stillbirth (death of the unborn baby in the womb) and baby's death in the first month of life Foreign agency - The U.S. Food and Drug Administration (US FDA)
List of Safety and Effectiveness Reviews Initiated from 2020-08-01 to 2020-08-31
Brand Name and / or Product Class / Medical Device(s) Medicinal Ingredient(s) Potential Safety Issue Trigger
  • Pomalyst
  • Thalomid
  • Pomalidomide
  • Thalidomide
Progressive multifocal leukoencephalopathy (a serious brain infection) Pharmacovigilance Risk Assessment Committee - European Medicines Agency
Review of the Issue-Related Summary Report (IRSR)
Kadcyla Trastuzumab emtansine Tumour Lysis Syndrome (quick cancer cells breakdown severely affecting many organs) 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)
Potential Safety Issue Trigger

Dopamine Agonists:

  • Bromocriptine-containing products
  • Ropinirole-containing products
  • Pramipexole-containing products
  • Rotigotine-containing products
  • Apomorphine-containing products
  • Pergolide-containing products
  • Cabergoline-containing products
  • Bromocriptine
  • Ropinirole
  • Pramipexole dihydrochloride
    monohydrate
  • Rotigotine
  • Apomorphine hydrochloride
  • Pergolide
  • Cabergoline
Dopamine Agonist Withdrawal Syndrome (DAWS, mental and physical withdrawal symptoms after stopping or reducing the dose of dopamine agonists) Request from the Therapeutic Products Directorate, Health Canada
List of Safety and Effectiveness Reviews Initiated from 2020-06-01 to 2020-06-30
Brand Name and / or Product Class / Medical Device(s) Medicinal Ingredient(s) Potential Safety Issue Trigger
Mid-Urethral Sling N/A Various intraoperative and postoperative complications (problems negatively affecting patients during and after surgery) Follow-up to a previous review completed in 2014 and recent scientific literature
List of Safety and Effectiveness Reviews Initiated from 2020-05-01 to 2020-05-31
Brand Name and / or Product Class / Medical Device(s) Medicinal Ingredient(s) Potential Safety Issue Trigger
Diphenhydramine single medicinal ingredient- containing products Diphenhydramine hydrochloride Serious side effects in children under 2 years of age and problematic use and overdose in children and adolescents under 18 years of age. Scientific literature
Cefuroxime-containing products Cefuroxime Kounis syndrome (sudden and reduced blood flow to the heart caused by an allergic reaction) Scientific literature
Sofosbuvir-containing products Sofosbuvir Severe cutaneous (skin) adverse reactions (SCAR) Foreign Agency - European Medicines Agency
List of Safety and Effectiveness Reviews Initiated from 2020-04-01 to 2020-04-30
Brand Name and / or Product Class / Medical Device(s) Medicinal Ingredient(s) Potential Safety Issue Trigger
Carboplatin-containing products Carboplatin Posterior reversible encephalopathy syndrome-PRES
(rare and serious brain condition)
Foreign agency - New Zealand Medicines and Medical Devices Safety Authority
Clobazam-containing products Clobazam Drug rash with eosinophilia and systemic symptoms (DRESS) syndrome (drug allergy reaction that results in rash, high white blood cell count, and affects one or more organs) Foreign agency - The U.S. Food and Drug Administration
Thiazide and thiazide-like diuretics
  • Chlorothiazide
  • Hydrochlorothiazide
  • Methychlothiazide
  • Indapamide
  • Chlorthalidone Metolazone
Choroidal effusion (accumulation of fluid in the eye) Foreign agency-European Medicines Agency
SpaceOAR System N/A Various systemic and local adverse events (bad reactions in the whole or specific areas of the body) Scientific literature
List of Safety and Effectiveness Reviews Initiated from 2020-03-01 to 2020-03-31
Brand Name and / or Product Class / Medical Device(s) Medicinal Ingredient(s) Potential Safety Issue Trigger
Ceftriaxone-containing products Ceftriaxone Encephalopathy (brain dysfunction) Foreign Agency-European Medicines Agency
Tramadol-containing products Tramadol hydrochloride Hallucinations (seeing, hearing, smelling, tasting, or feeling things that do not exist) and serious self-harm Follow-up to a previous review completed in 2019
Opdivo Nivolumab Autoimmune hemolytic anemia (disease when the body's immune system attacks and destroys its own red blood cells) Pharmacovigilance Risk Assessment Committee -European Medicines Agency
  • Enbrel
  • Erelzi
  • Humira
  • Remicade
  • Etanercept
  • Etanercept
  • Adalimumab
  • Infliximab
Mycosis fungoides (a type of cancer that begins in white blood cells called T cells, which develop abnormalities and attack the skin). World Health Organization Pharmaceuticals Newsletter
List of Safety and Effectiveness Reviews Initiated from 2020-02-01 to 2020-02-29
Brand Name and / or Product Class / Medical Device(s) Medicinal Ingredient(s) Potential Safety Issue Trigger
Baciject and generic bacitracin - containing products Bacitracin Nephrotoxicity (kidney toxicity), anaphylactic reactions (a sudden and severe allergic reaction) Foreign Agency - The U.S. Food and Drug Administration
Opdivo Nivolumab

Aplastic anemia (disease when the body stops producing enough new blood cells)

Cytokine release syndrome (severe inflammatory response in the body)

Tumour lysis syndrome (quick cancer cells breakdown severely affecting many organs)

Review of Periodic Benefit-Risk Evaluation Report
List of Safety and Effectiveness Reviews Initiated from 2020-01-01 to 2020-01-31
Brand Name and / or Product Class / Medical Device(s) Medicinal Ingredient(s) Potential Safety Issue Trigger
Breast implants N/A Breast implant-associated anaplastic large cell lymphoma - BIA-ALCL (a rare cancer of the immune system that can develop next to the implant) Follow up to a previous review completed in 2019
Tecentriq Atezolizumab 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)
Potential Safety Issue Trigger
Maviret Glecaprevir and pibrentasvir Hepatic failure (liver failure) and hepatic decompensation (worsening of liver function) Foreign Agency - The U.S. Food and Drug Administration
Zepatier Elbasvir and grazoprevir
Vosevi Sofosbuvir, velpatasvir and voxilaprevir
Clozaril and generic clozapine-containing products Clozapine Hematological monitoring (blood testing) Follow up to previous regulatory review completed in 2017
Picato Ingenol mebutate Skin cancer Foreign Agency - European Medicines Agency
Brilinta Ticagrelor 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)
Potential Safety Issue Trigger
Tamiflu Oseltamivir 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)
Potential Safety Issue Trigger
Antibiotic bone cements and cement spacers Gentamicin, tobramycin and vancomycin 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)
Potential Safety Issue Trigger
Mesalazine-containing products Mesalazine Congenital malformations (birth defects) Request from the Therapeutic Products Directorate, Health Canada
Brilinta Ticagrelor Worsening of bradyarrhythmia (slow, irregular heartbeats)
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)
Potential Safety Issue Trigger
Hydromorph Contin and generic hydromorphone controlled release capsules products Hydromorphone hydrochloride Increased risk of serious infections linked to the injection of the content of the capsules into the veins Scientific articles
Tapazole and generic methimazole-containing products Methimazole Vasculitis (inflammation of the blood vessels) Foreign Agency - The U.S. Food and Drug Administration
Dental amalgam N/A Safety of dental amalgam containing mercury Canadian Agency for Drugs and Technologies in Health Publication
Ibuprofen containing-products used in children Ibuprofen Necrotizing fasciitis (serious infection of the deep layers of the skin) in children with chickenpox infection Case report

No safety and effectiveness reviews initiated from 2019-07-01 to 2019-07-31

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)
Potential Safety Issue Trigger
Imodium Loperamide hydrochloride Cardiac (heart related) events Foreign agency - The U.S. Food and Drug Administration (US FDA) Safety Communications
Apo-Propylthiouracil, Propyl-Thyracil Propylthiouracil Congenital anomalies (birth defects), neonatal (newborn baby) disorders Foreign agency- European Medicines Agency (EMA)
Janus kinase (JAK) inhibitors: (Xeljanz, Xeljanz XR, Jakavi) Tofacitinib, ruxolitinib 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)
Potential Safety Issue Trigger
Imfinzi Durvalumab Hemolytic Anemia (increased red cell destruction and a decreased red cell life span) Drug manufacturer (response to Marketed Health Products Directorate letter)
Ketalar Ketamine Hepatic (liver) disorder Foreign agency - Newsletter from Agence Nationales de Sécurité du Médicament et des Produits de Santé (France)
Breast implants Silicone and saline- filled breast implants 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)
Potential Safety Issue Trigger
  • Daklinza
  • Galexos
  • Harvoni
  • Holkira Pak
  • Sovaldi
  • Technivie
  • Zepatier
  • Epclusa
  • Sunvepra
  • Maviret
  • Daclatasvir
  • glecaprevir
  • ombitasvir
  • paritaprevir
  • ritonavir
  • sofosbuvir
  • elbasvir
  • grazoprevir
  • simeprevir
  • ledipasvir
  • dasabuvir
  • velpatasvir
  • asunaprevir

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)
Potential Safety Issue Trigger

Tapazole mar-methimazole

Thiamazole

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)
Potential Safety Issue Trigger
  • Daklinza
  • Galexos
  • Harvoni
  • Holkira Pak
  • Sovaldi
  • Technivie
  • Zepatier
  • Epclusa
  • Sunvepra
  • Daclatasvir
  • ombitasvir
  • paritaprevir
  • ritonavir
  • sofosbuvir
  • elbasvir
  • grazoprevir
  • simeprevir
  • ledipasvir
  • dasabuvir
  • velpatasvir
  • asunaprevir

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)
Potential Safety Issue Trigger
Selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs)
  • Citalopram,
  • escitalopram,
  • fluoxetine
  • fluvoxamine,
  • paroxetine,
  • sertraline, venlafaxine, desvenlafaxine, duloxetine,
  • bupropion,
  • mirtazapine
Ongoing sexual dysfunction after stopping the use of the drug Pharmacovigilance Risk Assessment Committee - European Medicines Agency
Breast Implants (Allergan, Inc.; Mentor Medical Systems, B.V; MENTOR; IDEAL)
  • Natrelle saline-filled breast implants (smooth and textured),
  • natrelle 410 truform silicone-filled breast implants,
  • natrelle silicone-filled breast implants - biocell round,
  • natrelle silicone-filled breast implants - smooth round,
  • natrelle 150 Breast Implants,
  • natrelle inspira truform 1 (responsive) breast implants - smooth and biocell textured shell,
  • natrelle inspira truform 2 (soft touch) breast implants - smooth and biocell textured shell,
  • mentor memorygel cpg gel breast implants - cohesive iii
  • mentor memory gel silicone gel-filled breast implants - smooth and textured,
  • memorygel siltex becker expander/ breast implants saline-filled mammary prosthesis - smooth,
  • smooth spectrum saline filled mammary prosthesis,
  • siltex spectrum saline-filled mammary prosthesis,
  • saline-filled mammary prosthesis -textured
  • mentor memory gel,
  • silicone gel-filled breast implants - smooth and textured,
  • ideal implant saline-filled breast implant

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)
Potential Safety Issue Trigger

Systemic fluroquinolone antibiotics

  • Ciprofloxacin,
  • levofloxacin,
  • moxifloxacin,
  • norfloxacin

Aortic aneurysm (balloon-like bulge in an artery) and dissection (separation or tear in the layers of the wall of the aorta)

Pharmacovigilance Risk Assessment Committee - European Medicines Agency

  • Jardiance,
  • Qtern,
  • Synjardy,
  • Glyxambi,
  • Xigduo,
  • Forxiga,
  • Invokana,
  • Invokamet,
  • Invokamet XR,
  • Steglatro,
  • Steglujan,
  • Segluromet
  • Empagliflozin,
  • dapagliflozin,
  • canagliflozin,
  • ertugliflozin

Fournier's gangrene - necrotizing fasciitis (progressive inflammatory infection) of the perineum (area between the anus and the scrotum or vulva)

Foreign Agency (The U.S Food and Drug Administration)

Hormonal contraceptives

  • Levonorgestrel,
  • etonogestrel,
  • desogestrel,
  • norgestrel,
  • norgestimate,
  • norethindrone acetate,
  • norethindrone,
  • ethynodiol diacetate,
  • medroxyprogesterone acetate,
  • norelgestromin,
  • estradiol valerate,
  • drospirenone,
  • ethinyl estradiol
  • cyproterone acetate
  • dienogest/estradiol
Suicidality (suicidal thoughts and behaviours) European Medicines Agency
U by kotex sleek tampons (Medical device) N/A 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
Brand Name and / or Product Class /
Medical Device(s)
Medicinal
Ingredient(s)
Potential Safety Issue Trigger
  • ACT-propofol
  • Diprivan
  • PMS-propofol
  • Propofol
  • Propofol injection
Propofol Priapism (persistent and painful erection of the penis) Case reports
List of Safety and Effectiveness Reviews Initiated from 2018-08-01 to 2018-08-31
Brand Name and / or Product Class /
Medical Device(s)
Medicinal
Ingredient(s)
Potential Safety Issue Trigger
Laboratory tests (generic) Laboratory tests (generic) Biotin (vitamin B7) interference with lab tests and potential inappropriate patient management or misdiagnosis Foreign Agency (The U.S Food and Drug Administration)
Opdivo, Yervoy Nivolumab pilimumamb Histiocytosis haematophagic (an excessive number of activated macrophages eating blood cells) MBBNHPB Scientific Working Group/ European Medicines Agency
List of Safety and Effectiveness Reviews Initiated from 2018-07-01 to 2018-07-31
Brand Name and / or Product Class /
Medical Device(s)
Medicinal
Ingredient(s)
Potential Safety Issue Trigger
Xarelto Rivaroxaban Liver injury Follow up to previous review completed in 2015
List of Safety and Effectiveness Reviews Initiated from 2018-06-01 to 2018-06-30
Brand Name and / or Product Class /
Medical Device(s)
Medicinal
Ingredient(s)
Potential Safety Issue Trigger
Avalon fetal monitor (FM20, FM30, FM40, FM50)(medical device) N/A Inaccurate ultrasound-derived fetal heart rate readings (device error in the results of unborn baby's heart beat) Incident report
Hydrochlorothiazide Hydrochlorothiazide Non melanoma (all types of skin cancer that are not melanoma) Publication
List of Safety and Effectiveness Reviews Initiated from 2018-05-01 to 2018-05-31
Brand Name and / or Product Class /
Medical Device(s)
Medicinal
Ingredient(s)
Potential Safety Issue Trigger
Ferriprox Deferiprone Neurological disorders (conditions related to the brain or central nervous system) in children at recommended dosage Publication
Gilenya Fingolimod hydrochloride Rebound effect (emergence or re-emergence of symptoms) with product withdrawal. Foreign Agency - Signal Identification from Foreign Agencies
List of Safety and Effectiveness Reviews Initiated from 2018-04-01 to 2018-04-30
Brand Name and / or Product Class /
Medical Device(s)
Medicinal
Ingredient(s)
Potential Safety Issue Trigger
  • APO-sulfatrim DS TAB,
  • APO-sulfatrim pediatric,
  • APO-sulfatriM TAB,
  • Protrin DF TAB,
  • Septra injection,
  • TEVA-trimel,
  • TEVA-trimel DS
Sulfamethoxazole trimethoprim Drug reaction with eosinophilia and systemic symptoms (DRESS) Drug manufacturer (Voluntary Post Market Vigilance)
Opsumit Macitentan Liver injury Drug manufacturer (Periodic Safety Update Report (PSUR))
List of Safety and Effectiveness Reviews Initiated from 2018-03-01 to 2018-03-31
Brand Name and / or Product Class /
Medical Device(s)
Medicinal
Ingredient(s)
Potential Safety Issue Trigger
Contact lenses (medical devices) N/A Limbal stem cell deficiency (loss of stem cells (cells that can develop into different types of cell) in the limbus (border of the cornea and the sclera)) Publication
Liquid-filled intragastric balloon (medical device)
  • Orbera system,
  • endball system,
  • reshape device,
  • spatz3 system
Death, acute pancreatitis (sudden inflammation of the pancreas), gastric perforation ( hole that develops through the wall of the stomach), esophageal perforation (hole in the esophagus), spontaneous over-inflation (sudden excessive increase in size) Foreign Agency ( The U.S. Food and Drug Administration (US FDA)
Prescription opioids - cough and cold indication Codeine, hydrocodone Opioid use disorder (misuse/overdose) in pediatrics (children) US FDA
Urogynaecological (transvaginal) synthetic meshes (medical devices) N/A Various mesh (net-like implant) related complications Many sources including previous Health Canada Safety Reviews
List of Safety and Effectiveness Reviews Initiated from 2018-02-01 to 2018-02-28
Brand Name and / or Product Class /
Medical Device(s)
Medicinal
Ingredient(s)
Potential Safety Issue
Fibristal, Ella Ulipristal Serious liver injury
Toujeo, Lantus Insulin glargine Potential association of breast cancer with long-term use
List of Safety and Effectiveness Reviews Initiated from 2018-01-01 to 2018-01-31
Brand Name and / or Product Class /
Medical Device(s)
Medicinal
Ingredient(s)
Potential Safety Issue
APO-prednisone tablet, NU-prednisone, Prednisone tablet, TEVA-prednisone, Methylprednisolone sodium succinate for injection, PMS-prednisolone Prednisolone and prednisone Scleroderma renal crisis (fatal complication of scleroderma (abnormal growth of connective tissue) characterized by severe hypertension and renal (kidney) failure)fatal complication of scleroderma fatal complication of scleroderma fatal complication of scleroderma
Imbruvica Ibrutinib Ventricular arrhythmias (abnormal heart rhythm that comes from an area of the lower chamber (ventricle) of the heart) and sudden death
Metadol-D, Methadose Methadone hydrochloride Pharmacogenetic predisposition (how people respond differently to medicines due to their genetic inheritance) to methadone in children exposed to methadone through breast feeding
List of Safety and Effectiveness Reviews Initiated from 2017-12-01 to 2017-12-31
Brand Name and / or Product Class /
Medical Device(s)
Medicinal
Ingredient(s)
Potential Safety Issue

Antibiotics:

  • (Ceftriaxone for injection,
  • Ceftriaxone for injection USP, Ceftriaxone sodium for injection, Ceftriaxone sodium for injection BP, Ceftriaxone sodium for injection, BP Amoxi-Clav, Amoxicillin, Amoxicillin capsules, Amoxicillin granules for oral suspension, APO-Amoxicillin capsules 250mg,
  • APO-Amoxicillin capsules 500mg, APO-Amoxi Clav 250/125, APO-Amoxi Clav 500/125, APO-Amoxi Clav 875/125, APO-Amoxicillin powder for suspension 125mg/5ml, APO-Amoxicillin powder for suspension 250mg/5ml, APO-Amoxicillin sugar free, AURO-Amoxicillin,
  • Clavulin 125 F oral suspension,
  • Clavulin 200, Clavulin 250 F oral suspension, Clavulin 400,
  • Clavulin 500 F tablet, Clavulin 875, HP-PAC JAMP-Amoxicillin,
  • MYLAN-Amoxicillin, PMS-Amoxicillin, PRO -Amoxicillin -500 capsules 500mg, PRO-Amoxicillin - 250 oral suspension, 250mg/5ml,
  • RATIO-Aclavulanate, RATIO-Aclavulanate 250 F
Ceftriaxone sodium, amoxicillin, amoxicillin trihydrate Drug reaction with eosinophilia and systemic symptoms (DRESS), Severe cutaneous (skin) adverse reactions (SCAR)
Jakavi Ruxolitinib phosphate Potential drug interaction (with Crestor) due to suppression of p-glycoprotein
List of Safety and Effectiveness Reviews Initiated from 2017-11-01 to 2017-11-30
Brand Name and / or Product Class /
Medical Device(s)
Medicinal
Ingredient(s)
Potential Safety Issue
Remicade, Inflectra, Remsima Infliximab Linear IgA bullous dermatosis (rare disease due to autoimmune reaction)

VEGF Receptor Inhibitors:

(Caprelsa, Iclusig, Inlyta, Lenvima, Nexavar, Stivarga Sutent, Votrient)

Axitinib, lenvatinib, pazopanib, ponatinib, regorafenib, orafenib, sunitinib, vandetanib Aortic dissection (serious condition in which the inner layer of the aorta, the large blood vessel branching off the heart, tears)
List of Safety and Effectiveness Reviews Initiated from 2017-10-01 to 2017-10-31
Brand Name and / or Product Class /
Medical Device(s)
Medicinal
Ingredient(s)
Potential Safety Issue
Jardiance, Qtern, Synjardy, Glyxambi, Xigduo, Forxiga, Invokana, Invokamet Empagliflozin, linagliptin, dapagliflozin, saxagliptin, metformin hcl, canagliflozin Chronic pancreatitis (progressive inflammatory disease of the pancreas), acute pancreatitis (sudden inflammation of the pancreas)
Metadol-D, Methadose Methadone hydrochloride Pharmacogenetic predisposition (how people respond differently to medicines due to their genetic inheritance) to methadone in children exposed to methadone through breastfeeding
List of Safety and Effectiveness Reviews Initiated from 2017-09-01 to 2017-09-30
Brand Name and / or Product Class /
Medical Device(s)
Medicinal
Ingredient(s)
Potential Safety Issue
Metal-containing orthopedic hip implants (medical device) N/A Systemic (throughout the body) health consequences
List of Safety and Effectiveness Reviews Initiated from 2017-08-01 to 2017-08-31
Brand Name and / or Product Class /
Medical Device(s)
Medicinal
Ingredient(s)
Potential Safety Issue
Gleevec Imatinib Tendon disorders (disorders affecting a flexible but non-elastic piece of tissue in the body attaching a muscle to a bone)
PDP-Isoniazid Isoniazid Pancreatitis (inflammation of the pancreas)
Sunscreen Sunscreen products containing avobenzone, homosalate, octinoxate, octisalate, octocrylene and oxybenzone Hypersensitivity (abnormal reaction) and skin burn-type reactions
List of Safety and Effectiveness Reviews Initiated from 2017-07-01 to 2017-07-31
Brand Name and / or Product Class /
Medical Device(s)
Medicinal
Ingredient(s)
Potential Safety Issue
Halaven Eribulin mesylate Severe cutaneous (skin) adverse reactions (SCAR)

SGLT2 inhibitors

(Jardiance, Qtern, Synjardy, Glyxambi, Xigduo, Forxiga, Invokana, Invokamet)

Empagliflozin, linagliptin, dapagliflozin, saxagliptin, metformin hcl, canagliflozin Posterior reversible encephalopathy syndrome (PRES)
(rare brain condition) in association with diabetic ketoacidosis (high levels of acids in the blood)
Therapy ablation catheters (medical devices) N/A Atrioesophageal fistula (AEF) (abnormal connection between the heart and digestive tract)
List of Safety and Effectiveness Reviews Initiated from 2017-06-01 to 2017-06-30
Brand Name and / or Product Class /
Medical Device(s)
Medicinal
Ingredient(s)
Potential Safety Issue
Omnipod insulin management system (medical device) N/A Hyperglycemia (a condition in which too much glucose is in the blood)
Sevoflurane AF, generics Sevoflurane Bradycardia (a slower than normal heart rate) in children with Down Syndrome (a condition in which extra genetic material causes delays in the way a child develops, both physically and mentally)
List of Safety and Effectiveness Reviews Initiated from 2017-05-01 to 2017-05-31
Brand Name and / or Product Class /
Medical Device(s)
Medicinal
Ingredient(s)
Potential Safety Issue
Abilify, Saphris Clozaril, Latuda Zyprexa, Invega Invesga sustenna, Invega trinza, Seroquel, Seroquel xr Risperdal, Risperdal Consta, Zeldox Aripiprazole, asenapine, clozapine, lurasidone, olanzapine, paliperidone, paliperidone palmitate, quetiapine, quetiapine fumarate, risperidone, ziprasidone Drug reaction with eosinophilia and systemic symptoms (DRESS) (skin rash caused by a drug with increased white blood cell counts and symptoms in all parts of the body)
Enterra Therapy System (medical device) N/A Lack of effectiveness
Pradaxa Dabigatran Liver injury
List of Safety and Effectiveness Reviews Initiated from 2017-04-01 to 2017-04-30
Brand Name and / or Product Class /
Medical Device(s)
Medicinal
Ingredient(s)
Potential Safety Issue
Avonex Interferon beta-1a Sarcoidosis (disease involving the growth of tiny groups of inflammatory cells in different parts of the body - usually the lungs, lymph nodes, eyes and skin)
Trajenta, Januvia, Janumet, Janumet XR, Nesina, Kazano, Jentadueto, Onglyza, Komboglyze, Oseni, Qtern, Glyxambi Linagliptin, sitagliptin alogliptin, saxagliptin, linagliptin and metformin, alogliptin and metformin, saxagliptin and metformin, sitagliptin and metformin alogliptin and pioglitazone, saxagliptin and dapagliflozin, linagliptin and empagliflozin Bullous pemphigoid (rare skin condition that causes large pockets of body fluid)
List of Safety and Effectiveness Reviews Initiated from 2017-03-01 to 2017-03-31
Brand Name and / or Product Class /
Medical Device(s)
Medicinal
Ingredient(s)
Potential Safety Issue
Gilenya Fingolimod Thrombocytopenia (a condition in which the blood platelet count is low)

Viscoelastic devices:

Duovisc viscoelastic solution, provisc viscoelastic solution, viscoat ophthalmic viscoelastic device, cellugel viscosurgical device, discovisc ophthalmic viscosurgical device (medical devices)

N/A Toxic Anterior Segment Syndrome (TASS) (an acute inflammatory reaction in which a noninfectious substance enters the eye anterior segment and induces toxic damage to the surrounding tissues)
Zydelig Idelalisib Progressive multifocal leukoencephalopathy (a serious brain infection)
List of Safety and Effectiveness Reviews Initiated from 2017-02-01 to 2017-02-28
Brand Name and / or Product Class /
Medical Device(s)
Medicinal
Ingredient(s)
Potential Safety Issue
Effient Prasugrel hydrochloride Severe cutaneous (skin) adverse reactions (SCAR)
Fluconazole Fluconazole Spontaneous abortion/ miscarriage (loss of the fetus (unborn baby)) and congenital malformation (increased risk of birth defects)
Jakavi Ruxolitinib Liver injury including liver failure
TactiCath Quartz contact force ablation catheter (medical device) N/A Cardiac tamponade (medical condition in which blood or fluids fill the space between the sac that envelops the heart and the heart muscle)
List of Safety and Effectiveness Reviews Initiated from 2017-01-01 to 2017-01-31
Brand Name and / or Product Class /
Medical Device(s)
Medicinal
Ingredient(s)
Potential Safety Issue
Atypical antipsychotics Aripiprazole, paliperidone risperidone, asenapine quetiapine, ziprasidone olanzapine Complex sleep-related behaviour
Product Pump Inhibitors (PPI) Omeprazole, pantoprazole lansoprazole, rabeprazole esomeprazole, dexlansoprazole Drug-induced subacute cutaneous lupus erythematosus (an autoimmune disease whereby the immune system may attack some parts of the body and cause skin lesions. This condition can be caused by medication)
Specific benzodiazepines and barbiturates used in the setting of general anaesthesia and/or sedation (a relaxed, calm, or sleepy condition that results from taking a drug) Lorazepam, midazolam phenobarbital, thiopental Neurodevelopmental toxicity (toxicity affecting the development of the brain or central nervous system)
List of Safety and Effectiveness Reviews Initiated from 2016-12-01 to 2016-12-31
Brand Name and / or Product Class /
Medical Device(s)
Medicinal
Ingredient(s)
Potential Safety Issue
Breast implant (medical device) N/A Breast implant associated -anaplastic large cell lymphoma (ALCL) (a rare cancer of the immune system)
General anesthetics (part 1) Desflurane, Isoflurane, ketamine, Propofol, sevoflurane Neurodevelopmental toxicity (toxicity affecting the development of the brain or central nervous system)
Infusion pump with/without master drug library (medical device) N/A Various device failures (break down)
Lariam (discontinued), Mefloquine Mefloquine Long term neurological (related to the brain or central nervous system) and psychiatric adverse events
Mirena, Jaydess Levonorgestrel Suppressed lactation (blocked secretion of milk by the mammary glands)
List of Safety and Effectiveness Reviews Initiated from 2016-11-01 to 2016-11-30
Brand Name and / or Product Class /
Medical Device(s)
Medicinal
Ingredient(s)
Potential Safety Issue
Aubagio Teriflunomide Colitis (inflammation of the large intestine (colon))
Quill knotless tissue-closure devices (medical device) N/A Intestinal obstruction/volvulus (blockage that keeps food or liquid from passing through the intestine)
List of Safety and Effectiveness Reviews Initiated from 2016-10-01 to 2016-10-31
Brand Name and / or Product Class /
Medical Device(s)
Medicinal
Ingredient(s)
Potential Safety Issue
Aubagio Teriflunomide Acute renal (sudden kidney) failure
List of Safety and Effectiveness Reviews Initiated from 2016-09-01 to 2016-09-30
Brand Name and / or Product Class /
Medical Device(s)
Medicinal
Ingredient(s)
Potential Safety Issue
Aerius Deloratadine QT prolongation and torsade de pointes (heart rhythm problem)
Brilinta Ticagrelor Severe (skin) cutaneous adverse reactions (SCAR)
Green Tea Green tea extract Liver injury
Parenteral nutrition solutions (Primene, Prosol, Clinimix, Olimel, Travasol, Smofkabiven, Aminosyn) Amino acid Increased mortality in pre-term infants (premature babies who are born before 37 completed weeks of gestation) when solution is not shielded (protected) from light
Tecfidera Dimethyl fumarate Renal (kidney) injury, including acute renal failure
List of Safety and Effectiveness Reviews Initiated from 2016-08-01 to 2016-08-31
Brand Name and / or Product Class /
Medical Device(s)
Medicinal
Ingredient(s)
Potential Safety Issue
DPP-4 inhibitors Alogliptin, linaglipton, sitaglipton, saxaglipton Heart failure
Heater-cooler system N/A Contamination/infections
Intraocular lens N/A Development of glistening (sparkling or shining reflection) in intraocular lens
Iodine contrast agents Diatrizoate, iodipamide, iopamidol, ioxitalamate, ioversol, iothalamate, iodixanol, iohexol, iopromide Hypothyroidism (abnormally low activity of the thyroid gland)
Proscar, Propecia Finasteride Muscle-related side effects
Voluven, Volulyte Hydroxyethyl starch Acute kidney injury in non-critically ill trauma, and elective surgery patients (sudden kidney injury in patients who are injured but not very sick or have had surgery that is not urgent)
List of Safety and Effectiveness Reviews Initiated from 2016-07-01 to 2016-07-31
Brand Name and / or Product Class /
Medical Device(s)
Medicinal
Ingredient(s)
Potential Safety Issue
Direct-acting antivirals indicated for the treatment of hepatitis C (Daklinza, Epclusa, Galexos, Harvoni, Holkira Pak, Sovaldi, Technivie, Zepatier) Asunaprevir, daclatasvir, dasabuvir, elbasvir, grazoprevir, ledipasvir, ombitasvir, paritaprevir, ritonavir, simeprevir, sofosbuvir, velpatasvir Early recurrence of hepatocellular carcinoma (liver cancer)
Direct-acting antivirals indicated for the treatment of hepatitis C (Daklinza, Epclusa, Galexos, Harvoni, Holkira Pak, Sovaldi, Technivie, Zepatier) Asunaprevir, daclatasvir, dasabuvir, elbasvir, grazoprevir, ledipasvir, ombitasvir, paritaprevir, ritonavir, simeprevir, sofosbuvir, velpatasvir Hepatitis B reactivation
List of Safety and Effectiveness Reviews Initiated from 2016-06-01 to 2016-06-30
Brand Name and / or Product Class /
Medical Device(s)
Medicinal
Ingredient(s)
Potential Safety Issue
Aclasta, Zometa, Fosamax, Fosavance, Bonefos, Clasteon, Didrocal, Etidrocal Pamidronate, Actonel, Actonel DR Zoledronic acid, alendronate, clodronate etidronate, pamidronate risedronate Non-mandibular osteonecrosis (death of tissue in bones other than the jaw)
Hospital beds Hospital beds Entrapment (patient is caught in the spaces between the bed rail, mattress or hospital bed frame)
List of Safety and Effectiveness Reviews Initiated from 2016-05-01 to 2016-05-31
Brand Name and / or Product Class /
Medical Device(s)
Medicinal
Ingredient(s)
Potential Safety Issue
Stent system Esophageal stent systems Erosion of vascular structure (wearing away of blood vessels)
List of Safety and Effectiveness Reviews Initiated from 2016-04-01 to 2016-04-30
Brand Name and / or Product Class /
Medical Device(s)
Medicinal
Ingredient(s)
Potential Safety Issue

Dipeptidylpeptidase-4 (DPP-4) inhibitors

(Januvia, Janumet, Onglyza, Komboglyze, Trajenta, Jentadueto, Nesina, Kazano, Oseni)

Sitagliptin, saxagliptin, linagliptin, alogliptin, (metformin combination) Serious arthralgia (joint pain)

Gadolinium containing products

(Magnevist, Gadovist, Omniscan, Multihance, Optimark, Prohance, Primovist)

Gadoversetamide, gadobutrol, gadopentetate, gadobenate, dadodiamide, gadoteridol, gadoxetate Build-up of the Gadolinium containing products in the brain
Tysabri Natalizumab Hematological disorders (disorders mainly affecting the blood) in neonates (newborns)
Xalkori Crizotinib Gastrointestinal perforation (hole that develops through the wall of the stomach, small intestine, large intestine, gallbladder or rectum
Zydelig Idelalisib Serious infections/death
List of Safety and Effectiveness Reviews Initiated from 2016-03-01 to 2016-03-31
Brand Name and / or Product Class /
Medical Device(s)
Medicinal
Ingredient(s)
Potential Safety Issue
Antidepressants Citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline Autism spectrum disorders (a group of disorders that shows a lack of social skills, difficulty in communicating, repeating behaviours, and a slow mental development) in children
Avastin Bevacizumab Non-mandibular osteonecrosis (death of tissue in bones other than the jaw) in adult population
Counterirritants containing menthol, methyl salicylate or capsaicin Menthol, methyl salicylate and capsaicin Serious skin burns
List of Safety and Effectiveness Reviews Initiated from 2016-02-01 to 2016-02-29
Brand Name and / or Product Class /
Medical Device(s)
Medicinal
Ingredient(s)
Potential Safety Issue
Accutane Isotretinoin Erectile dysfunction (the inability to get and keep an erection firm enough for sex)
Aclasta, Aredia, Bonefos, Clasteon Zoledronic acid, pamidronate, clodronate (injectable bisphosphonate) Osteonecrosis of the jaw (a severe bone disease that affects the jaw)
Amiodarone hydrochloride for injection Amiodarone hydrochloride Fetal (unborn baby) and neonatal (newborn) side effects including cardiac and neurodevelopmental events (development of the brain or central nervous system)
Cervarix Human papillomavirus Types 16 and 18 (Recombinant, AS04 adjuvanted) Guillain-Barré syndrome (a rapid-onset muscle weakness caused by the immune system damaging the peripheral nervous system)
Keppra Levetiracetam Impaired renal (kidney) function
Systemic fluoroquinolone antibiotics Ciprofloxacin, levofloxacin, moxifloxacin, norfloxacin, ofloxacin Persistent disabilities: skeletal muscular, neuro-psychiatric (mental disorders related to diseases of the nervous system), tendonitis (inflammation of a tendon), peripheral neuropathy (damage to or disease affecting peripheral nerves), vision disturbances and phototoxicity (skin irritations caused by chemicals reacting to light)
List of Safety and Effectiveness Reviews Initiated from 2016-01-01 to 2016-01-31
Brand Name and / or Product Class /
Medical Device(s)
Medicinal
Ingredient(s)
Potential Safety Issue
Codeine (prescription codeine-containing products for pain) Codeine Fatal (causing death) and life-threatening respiratory side effects (very slow breathing requiring emergency care) in children and adolescents (up to 18 years of age)
Loratadine Loratadine QT prolongation and torsade de pointes (heart rhythm problem)
Phenylephrine Phenylephrine Phenylephrine drug interaction with acetaminophen
List of Safety and Effectiveness Reviews Initiated from 2015-12-01 to 2015-12-31
Brand Name and / or Product Class /
Medical Device(s)
Medicinal
Ingredient(s)
Potential Safety Issue
Clozaril, Clozapine Clozapine Hematological monitoring (monitoring of disease of the blood and bone marrow)
Codeine (non-prescription codeine-containing products (for cough and cold and pain/antipyretic)) Codeine Risk of respiratory depression in children and adolescents (up to 18 years of age)
Januvia, Janumet, Janumet XR, Onglyza, Komboglyze & Trajenta, Jentadueto, Nesina, Kazano Sitagliptin, linagliptin, alogliptin, saxagliptin Gastrointestinal obstruction (blockage that keeps food or liquid from passing through the intestine)
Neurontin, Gabapentin Gabapentin Life-threatening respiratory depression (very slow breathing requiring emergency care), without concomitant opioid use
Zelboraf Vemurafenib Bone marrow toxicity/suppression (white blood cells suppression)
Zofran Ondansetron hydrochloride dehydrate Fetal (unborn baby) harm

No safety and effectiveness reviews initiated from 2015-11-01 to 2015-11-30

List of Safety and Effectiveness Reviews Initiated from 2015-10-01 to 2015-10-31
Brand Name and / or Product Class /
Medical Device(s)
Medicinal
Ingredient(s)
Potential Safety Issue
Forxiga, Invokana, Jardiance (SGLT2 class inhibitors) Dapagliiflozin, canagliflozin, empagliflozin Increased risk of bone fractures, due to loss of bone mineral density
Avonex, Betaseron, Extavia, Plegridy, Rebif
(Beta-interferons)
Interferon beta Risk of pulmonary arterial hypertension (type of high blood pressure that affects the arteries in the lungs and the right side of the heart).
List of Safety and Effectiveness Reviews Initiated from 2015-07-01 to 2015-09-30
Brand Name and / or Product Class /
Medical Device(s)
Medicinal
Ingredient(s)
Potential Safety Issue
Atypical Antipsychotic: Abilify, Clozaril, Invega, Latuda, Risperdal, Seroquel, Zeldox, Zyprexa Aripiprazole, clozapine, paliperidone, lurasidone, risperidone, quetiapine, ziprasidone, olanzapine Urinary retention (temporary difficulty urinating and incomplete bladder emptying)
Bexsero Neisseria meningitidis group B Safety of vaccination with Bexsero in older patients
Digoxin, Apo-Digoxin, Lanoxin, PMD-digoxin, Toloxin Digoxin Increased mortality (death)

Dimetane Expectorant DC, Tussionex, PMS-hydrocodone, Novahistine, Dalmacol, Hycodan, Novahistex DH, Ratio-calmydone, Tramacet, Zytram, Tridural, Ralivia, Ultram, Durela, and generic formulations of tramadol.

Hydrocodone and tramadol containing products

Life-threatening respiratory depression (very slow breathing requiring emergency care) in children

  • Estrogen-only hormone replacement therapy (C.E.S., Climara, Divigel, Estrace, Estradot, Estragyn, Estring, Estrogel, Oesclim, Premarin, Vagifem)
  • Estrogen and progestogen combination hormone replacement therapy (Activelle, Angeliq, Climara Pro, Estalis, Estrogel Propak, FemHRT, Prefesta, Premplus)
  • Progestogen-only for use with estrogen replacement therapy (Prometrium, Provera)
  • Estrogen and selective estrogen receptor modulator combination (Duavive)
  • Selective estrogen receptor modulator (Evista)
  • 17β-Estradiol, conjugated estrogens, estrone, ethinyl estradiol
  • Drospirenone, progesterone, levonogestrel, medroxyprogesterone, norethindrone, norgestimate
  • Bazedoxifene, raloxifene,
Ovarian cancer in menopausal women (a type of cancer detected in the ovaries)
Exelon Rivastigmine hydrogen tartrate Increased mortality (death)
Gilenya Fingolimod Progressive multifocal leukoencephalopathy (a serious brain infection)
Gilenya Fingolimod Malignancies (tumors which are cancerous and can cause serious illness or death), neoplasms (new and abnormal growth of tissues)
Havrix Hepatitis A inactivated Immune thrombocytopenic purpura (ITP) (a disorder that can lead to easy or excessive bruising and bleeding)
Intuniv XR Guanfacine hydrochloride Raynaud's phenomenon (disorder that causes some areas of the body to feel numb and cold as a result of a limited blood circulation)
Keppra Levetiracetam Drug-drug interaction with methotextrate
Proscar and Propecia Finasteride Convulsions (seizures)
Soliris Eculizumab Use of Soliris in patients that are receiving meningococcal B vaccine at the same time
Yondelis Trabectedin Capillary leak syndrome (disorder that can lead to a leak of fluid from the blood vessels into the body's tissues)
List of Safety and Effectiveness Reviews Initiated from 2015-04-01 to 2015-06-30
Brand Name and / or Product Class /
Medical Device(s)
Medicinal
Ingredient(s)
Potential Safety Issue
Alpha-lipoic acid Alpha-lipoic acid Insulin autoimmune syndrome (IAS) or Hirata's disease (rare disorder characterized by hypoglycemia caused by insulin autoantibodies)
Atypical antipsychotic: Abilify, Clozaril, Invega, Latuda, Risperdal, Seroquel, Zeldox, Zyprexa Aripiprazole, clozapine, paliperidone, lurasidone, risperidone, quetiapine, ziprasidone, olanzapine Sleep apnea (serious sleep disorder in which breathing repeatedly stops and restarts)
Diclectin Doxylamine - pyridoxine HCL Adverse/neonatal outcomes
Forxiga, Invokana Dapagliflozin, canagliflozin Ketoacidosis (high blood levels of ketones (acids))
Sudafed 120 mg Pseudoephedrine Ischemic colitis (blood flow to part of the large intestine (colon) is decreased due to narrowed or blocked blood vessels (arteries))
Tysabri Natalizumab Hemolytic anaemia (increased red cell destruction and a decreased red cell life span)
Velcade Bortezomib Necrotizing fasciitis (rare bacterial infection also called flesh-eating disease)
List of Safety and Effectiveness Reviews Initiated from 2015-01-01 to 2015-03-31
Brand Name and / or Product Class /
Medical Device(s)
Medicinal
Ingredient(s)
Potential Safety Issue
Avastin bevacizumab Vocal cord necrosis (death of cells or tissue of the vocal cord)
Avonex interferon beta-1a Risk of nephrotic syndrome (a collection of symptoms that indicate kidney damage)
Chlorhexidine solutions chlorhexidine Anaphylactic reactions (severe allergic reactions)
Chlorhexidine solutions chlorhexidine Skin injuries, including burns, in premature infants
Cimzia certolizumab Autoimmune hepatitis (inflammation of the liver that occurs when the body's immune system attacks the liver)
Codeine-containing products Codeine Death and life threatening adverse events in children
Eprex epoetin alfa Evaluation of a new method for calculating the number of patients exposed to the drug
Eylea aflibercept Higher systemic exposure after intravitreal injection (higher levels of the medicine in the body after injection into the eye) compared to the drug ranibizumab
Gardasil recombinant human papillomavirus type 6L1, 11L1, 16L1, 18L1 protein Associated adverse events with a focus on autoimmune diseases (when the immune system attacks the body) and cardiovascular diseases (involving the heart or blood vessels)
Humira adalimumab Autoimmune hepatitis (inflammation of the liver that occurs when the body's immune system attacks the liver)
Invokana canagliflozin Renal impairment (inability of the kidneys to work properly)
Lidocaine, topical oral anesthetic viscous lidocaine Serious adverse reactions in infants and young children, including seizure, severe brain injury, heart problems, and death
Prolia and Xgeva denosumab Deafness
Simponi golimumab Autoimmune hepatitis (inflammation of the liver that occurs when the body's immune system attacks the liver)
Tazocin piperacillin-tazobactam (combination) Drug rash with eosinophilia and systemic symptoms (DRESS) (skin rash caused by a drug with increased white blood cell counts and symptoms in all parts of the body)
Uloric febuxostat Heart failure
WinRho SDF RhoD immune globulin (human) Reactions linked the manufacturing of the product
List of Safety and Effectiveness Reviews Initiated from 2014-10-01 to 2014-12-31
Brand Name and / or Product Class /
Medical Device(s)
Medicinal
Ingredient(s)
Potential Safety Issue
Actos pioglitazone HCL Bladder cancer
Antidepressants desipramine; imipramine; clomipramine; doxepin; trimipramine; amitriptyline; nortriptyline; maprotiline; mirtazapine; phenelzine; tranylcypromine; moclobemide; fluoxetine; citalopram; paroxetine; sertraline; fluvoxamine; escitalopram; venlafaxine; desvenlafaxine; duloxetine; trazodone; bupropion Angle-closure glaucoma (increased eye pressure)
Clear Care cleaning and disinfecting solution for contact lenses 3% hydrogen peroxide Eye injuries
Enbrel etanercept Increased risk of congenital malformation (increased risk of birth defects)
Galexos simeprevir Remarkable increase in blood bilirubin level
Helixate FS and Kogenate FS antihemophilic factor (recombinant) Higher risk of inhibitor development in previously untreated patients compared to another widely used product (higher risk of developing antibodies that can reduce how well the treatment works in patients receiving the product for the first time)
Melatonin melatonin Use of melatonin in children
Octagam 5% and 10% immunoglobulin G (human) Lack of efficacy, and safety issues relating to the modifications of the manufacturing process (hypersensitivity, thrombosis)
Perjeta pertuzumab Stevens-Johnson syndrome (life-threatening skin condition)
Uloric febuxostat Drug rash with eosinophilia and systemic symptoms (DRESS) (skin rash caused by a drug with increased white blood cell counts and symptoms in all parts of the body)
Uloric febuxostat Hematological effects (Effects related to the blood and blood forming organs)
Velcade Bortezomib Necrotizing fasciitis (flesh-eating disease)
Xarelto rivaroxaban Liver injury
Yervoy ipilimumab Drug rash with eosinophilia and systemic symptoms (DRESS) (skin rash caused by a drug with increased white blood cell counts and symptoms in all parts of the body)
List of Safety and Effectiveness Reviews Initiated from 2014-07-01 to 2014-09-30
Brand Name and / or Product Class /
Medical Device(s)
Medicinal
Ingredient(s)
Potential Safety Issue
Atarax hydroxyzine QT prolongation and torsade de pointes (heart rhythm problem)
Celebrex celecoxib Arterial thromboembolism (blocking of an artery)
Enbrel etanercept Schizophrenia-like disorders
Gleevec imatinib mesylate Chronic renal impairment (chronic kidney disease)
Revolade eltrombopag Severe skin reactions
Tumour necrosis factor alfa (TNF α) inhibitors certolizumab pegol, etanercept, adalimumab, infliximab, golimumab Glioblastoma (type of brain tumour)
Topical benzoyl peroxide-containing products benzoyl peroxide Hypersensitivity/ anaphylactic reactions (severe allergic reactions)

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