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 2018-04-01 and 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))
Safety reviews started between 2018-03-01 and 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
Safety reviews started between 2018-02-01 and 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
Safety reviews started between 2018-01-01 and 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
Safety reviews started between 2017-12-01 and 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
Safety reviews started between 2017-11-01 and 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, sorafenib,
sunitinib, vandetanib
Aortic dissection  (serious condition in which the inner layer of the aorta, the large blood vessel branching off the heart, tears)
Safety reviews started between 2017-10-01 and 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
Safety reviews started between 2017-09-01 and 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
Safety reviews started between 2017-08-01 and 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
Safety reviews started between 2017-07-01 and 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)
Safety reviews started between 2017-06-01 and 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)
Safety reviews started between 2017-05-01 and 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
Safety reviews started between 2017-04-01 and 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)
Safety reviews started between 2017-03-01 and 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)
Safety reviews started between 2017-02-01 and 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)
Safety reviews started between 2017-01-01 and 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)
 
Safety reviews started between 2016-12-01 and 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)
Safety reviews started between 2016-11-01 and 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) 
Safety reviews started between 2016-10-01 and 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
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-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)
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)
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