Health Canada
Symbol of the Government of Canada

Common menu bar links

Drugs and Health Products

New Safety Reviews

The following tables list the safety 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 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.

Safety reviews started between 2016-09-01 and 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
Safety reviews started between 2016-08-01 and 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)
Safety reviews started between 2016-07-01 and 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
Safety reviews started between 2016-06-01 and 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)
Safety reviews started between 2016-05-01 and 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)
Safety reviews started between 2016-04-01 and 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
Safety reviews started between 2016-03-01 and 2016-03-31
Brand Name 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
Safety reviews started between 2016-02-01 and 2016-02-29
Brand Name 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-Barr 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)
Safety reviews started between 2016-01-01 and 2016-01-31
Brand Name 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
Safety reviews started between 2015-12-01 and 2015-12-31
Brand Name 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 reviews were started between 2015-11-01 and 2015-11-30

Safety reviews started between 2015-10-01 and 2015-10-31
Brand Name 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).
Safety reviews started between 2015-07-01 and 2015-09-30
Brand Name 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)
Safety reviews started between 2015-04-01 and 2015-06-30
Brand Name 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)
Safety reviews started between 2015-01-01 and 2015-03-31
Brand Name 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
 
Safety reviews started between 2014-10-01 and 2014-12-31
Brand Name 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)
 
Safety reviews started between 2014-07-01 and 2014-09-30
Brand Name 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)