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.
| Brand Name and / or Product Class / Medical Device(s) | Medicinal Ingredient(s) | Potential Safety Issue | Trigger | |
|---|---|---|---|---|
| Prescription opioid-containing products | All prescription opioids | Esophageal dysfunction (impaired function of the esophagus) | Scientific literature | |
No safety and effectiveness reviews initiated from 2024-08-01 to 2024-08-31
| Brand Name and / or Product Class / Medical Device(s) |
Medicinal Ingredient(s) | Potential Safety Issue | Trigger |
|---|---|---|---|
| Herbal supplements containing curcumin and/or turmeric | Curcumin, turmeric | Hepatotoxicity (liver injury) | Foreign agency - Australian Therapeutic Goods Administration (TGA) |
| Brand Name and / or Product Class / Medical Device(s) |
Medicinal Ingredient(s) | Potential Safety Issue | Trigger |
|---|---|---|---|
| Cyclin-dependent kinase inhibitors (CDKIs) | Palbociclib, ribociclib, abemaciclib | Rhabdomyolysis (muscle breakdown) due to drug interaction with HMG-CoA reductase inhibitors (statins) | Foreign agency - European Medicines Agency (EMA) |
| Garcinia cambogia-containing products | Garcinia cambogia (garcinia gummi-gutta) | Hepatotoxicity (liver injury) | Scientific literature |
| Nitric oxide- or treprostinil-containing products (pulmonary vasodilators) | Nitric oxide, treprostinil | 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 |
| Brand Name and / or Product Class / Medical Device(s) |
Medicinal Ingredient(s) | Potential Safety Issue | Trigger |
|---|---|---|---|
| Gadolinium-based contrast agents | Gadoterate meglumine, gadobutrol, gadopentetate dimeglumine, gadobenate dimeglumine, gadodiamide, gadoxetate disodium, gadoteridol | Serious adverse reactions, including seizure, encephalopathy (brain dysfunction), coma and death, with intrathecal (injection into the spinal canal) use | Foreign agency - U.S. Food and Drug Administration (US FDA) |
No safety and effectiveness reviews initiated from 2024-04-01 to 2024-04-30
| 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) |
| Stivarga | Regorafenib | Thrombotic microangiopathy (blood clotting disorder affecting small blood vessels) | Foreign agency – European Medicines Agency (EMA) |
| 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) | 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
| 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
| 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
| 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) |
| 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) |
| 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 |
| 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
| 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
| 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) |
| 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
| 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 |
| 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 |
| 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
| 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) |
| 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 |
| 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
| 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 |
| 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
| 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
| 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 |
| 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) |
| Brand Name and / or Product Class / Medical Device(s) |
Medicinal Ingredient(s) | Potential Safety Issue | Trigger |
|---|---|---|---|
Aromatase inhibitors: Letrozole-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 |
| 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 |
|
Tofacitinib | Major Adverse Cardiovascular Events (MACE, serious heart-related problems) | Drug manufacturer (information from a clinical trial) |
|
Tofacitinib | Malignancy (cancer) | Drug manufacturer (information from a clinical trial) |
|
|
|
Foreign Agency- The U.S. Food and Drug Administration (US FDA) |
|
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
| 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 |
| 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 |
|
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 |
| 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) |
| Brand Name and / or Product Class / Medical Device(s) | Medicinal Ingredient(s) | Potential Safety Issue | Trigger |
|---|---|---|---|
Gadolinium-Based Contrast Agents:
|
|
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) |
| Brand Name and / or Product Class / Medical Device(s) | Medicinal Ingredient(s) | Potential Safety Issue | Trigger |
|---|---|---|---|
|
|
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 |
| Brand Name and / or Product Class / Medical Device(s) | Medicinal Ingredient(s) |
Potential Safety Issue | Trigger |
|---|---|---|---|
Dopamine Agonists:
|
|
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 |
| 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 |
| 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 |
| 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 |
|
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 |
| 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 |
|
|
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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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
| 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) |
| 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 |
| Brand Name and / or Product Class / Medical Device(s) |
Medicinal Ingredient(s) |
Potential Safety Issue | Trigger |
|---|---|---|---|
|
|
Dysglycaemia (abnormality in blood sugar stability - can include low blood sugar or high blood sugar. |
European Medicines Agency Assessment |
| 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 |
| Brand Name and / or Product Class / Medical Device(s) |
Medicinal Ingredient(s) |
Potential Safety Issue | Trigger |
|---|---|---|---|
|
|
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) |
|
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) |
|
Breast implants linked to anaplastic large cell lymphoma - BIA-ALCL (rare type of blood cancer) |
Many articles and foreign agency notices |
| Brand Name and / or Product Class / Medical Device(s) |
Medicinal Ingredient(s) |
Potential Safety Issue | Trigger |
|---|---|---|---|
Systemic fluroquinolone antibiotics |
|
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 |
|
|
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 |
|
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 |
| Brand Name and / or Product Class / Medical Device(s) |
Medicinal Ingredient(s) |
Potential Safety Issue | Trigger |
|---|---|---|---|
|
Propofol | Priapism (persistent and painful erection of the penis) | Case reports |
| 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 |
| 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 |
| 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 |
| 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 |
| Brand Name and / or Product Class / Medical Device(s) |
Medicinal Ingredient(s) |
Potential Safety Issue | Trigger |
|---|---|---|---|
|
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)) |
| 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) |
|
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 |
| 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 |
| 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 |
| Brand Name and / or Product Class / Medical Device(s) |
Medicinal Ingredient(s) |
Potential Safety Issue |
|---|---|---|
Antibiotics:
|
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 |
| 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) |
| 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 |
| 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 |
| 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 |
| 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) |
| 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) |
| 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 |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| Brand Name and / or Product Class / Medical Device(s) |
Medicinal Ingredient(s) |
Potential Safety Issue |
|---|---|---|
| Aubagio | Teriflunomide | Acute renal (sudden kidney) failure |
| 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 |
| 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) |
| 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 |
| 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) |
| 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) |
| 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 |
| 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 |
| 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) |
| 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 |
| 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
| 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). |
| 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 |
|
|
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) |
| 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) |
| 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 |
| 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) |
| 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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