Drug Advisories

CMAJ is committed to publishing advisories and warnings of serious adverse drug reactions from Health Canada (HC) and the US Food and Drug Administration (FDA) as soon as they are available. In addition, we regularly create practical, readable summaries of the important information contained in some advisory and warning letters. For more information about drug reactions reported in Canada, see the Health Canada Web site.

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 Advisory From Date posted
Antidepressant Venlafaxine (Effexor)': Increased risk of death in overdose situations' HC October 29, 2008
Thoratec HeartMate II Left Ventricular Assist System: lead failure FDA October 29, 2008
LifePak defibrillator failures HC October 22, 2008
Psoriasis treatment efalizumab (Raptiva): risk of life threatening infections FDA October 22, 2008
Transvaginal Placement of Surgical Mesh complications FDA October 22, 2008
Tylenol with codeine in rapid metabolizing nursing mothers HC October 8, 2008
Tiotropium (Spiriva): no increased risk of stroke FDA October 8, 2008
Statin drugs and ALS: No increased incidence is trials FDA October 1, 2008
Anemia treatment erythropoietin (Epoetin-alpha): increased deaths compared to placebo in trial FDA September 26, 2008
Lung cancer chemotherapy agent erlotinib (Tarceva) : liver failure and hepatorenal syndrome FDA September 24, 2008
Phosphocol P 32 and increased risk for leukemia FDA September 19, 2008
Rheumatoid arthritis treatment Rituximab (Rituzan) and PML: New prescribing information after a patient death FDA September 12, 2008
Tumour necrosis factor-alpha blockers (TNF blockers) Cimzia (certolizumab pegol), Enbrel (etanercept), Humira (adalimumab), and Remicade (infliximab): risk of opportunistic infections FDA September 5, 2008
Exenatide (Byetta) type 2 diabetes treatment: hemorrhagic or necrotizing pancreatitis FDA September 4, 2008
HIV drug Viracept (nelfinavir mesylate) Can Be Used Again In Non-Pregnant Patients HC September 4, 2008
Simvastatin and Ezetimibe in Aortic Stenosis (SEAS) trial: possible increased incidence of cancer FDA September 4, 2008
Natalizumab (Tysabri) monotherapy for multiple sclerosis: progressive multifocal leukoencephalopathy (PML) FDA September 3, 2008
Milk Allergy Risk with some brands of "Non-Dairy" Acidophilus Products HC August 14, 2008
Amiodarone and simvastatin: Rhabdomyolysis interaction possible FDA August 14, 2008
Immune modulator temsirolimus (TORISEL) injection and hypersensitivity reactions HC August 14, 2008
Alcohol dependence treatment naltrexone (Vivitrol): injection adverse effects FDA August 14, 2008
Fatal reaction of antibiotic ceftriaxone and calcium HC August 1, 2008
Erythropoiesis Stimulating Agents: Procrit, Epogen, Aranesp warnings FDA August 1, 2008
Contaminated metformin lot HC July 30, 2008
Timolol eye drop recall HC July 30, 2008
Multiple Sclerosis treatment mitoxantrone (Novantrone): Measure LVEF first FDA July 30, 2008
Abacavir/Ziagen : Hypersensitivity reactions linked to specific HLA allele FDA July 25, 2008
DDAVP Nasal Spray (desmopressin acetate nasal spray): risk of hyponatremia HC July 23, 2008
Bubble contrast agents: Concerns FDA July 18, 2008
Sodium polystyrene suspension recall: contamination of product FDA July 17, 2008
Failure of electronic medical devices after exposure to Xrays from CT scans FDA July 17, 2008
Multidose epinephrine autoinjector: Device failures HC July 17, 2008
Bevacizumab (AVASTIN) and sunitinib malate: microangiopathic anemia HC July 17, 2008
Fluoroquinolone use and tendinitis and tendon rupture FDA July 10, 2008
Slow release morphine recall: Inconsistent dosing HC July 10, 2008
Recombinant Human Bone Morphogenetic Protein: Reports Of Life-threatening Complications In Cervical Spine Fusion FDA July 2, 2008
Organ transplant drug mycophenolate mofetil (CellCept): Progressive Multifocal Leukoencephalopathy in some patients FDA July 2, 2008
Acromegaly treatment pegvisomant (SOMAVERT) in combination with octreotide: liver effects HC June 11, 2008
natalizumab (Tysabri): Serious liver injury HC June 9, 2008
Ultrasound contrast agent DEFINITY (Perflutren Injectable Suspension): serious adverse cardiopulmonary reactions HC May 28, 2008
Toothpaste alert HC May 28, 2008
Immune modulator drug mycophenolate mofetil (MMF) and congetinal anomalies FDA May 21, 2008
Darunavir (Prezista): hepatotoxicity HC May 16, 2008
Aprotinin (Trasylol) and high risk cardiac surgery HC May 16, 2008
Arthritis immune modifier etanercept (Enbrel): sepsis and tuberculosis infections FDA May 2, 2008
Foreign product warnings: contamination with pharmaceuticals HC May 2, 2008
Organ rejection drugs CellCept and Myfortic: association with progressive multifocal leukoencephalopathy (PML) FDA April 16, 2008
Daptomycin for injection (Cubicin)- Impurity Isolated From Reconstituted Product FDA April 10, 2008
Inhaled insulin Exubera (insulin human rDNA origin) and lung cancer cases FDA April 10, 2008
Influenza treatment zanamivir (Relenza): delirium FDA April 3, 2008
Oral asthma treatment montelukast (Singulair) and suicidality FDA March 28, 2008
Regranex (becaplermin) Gel, for leg and foot ulcers: possible increased risk of death from cancer FDA March 28, 2008
HIV drugs Abacavir (Ziagen) and didanosine (Videx) and heart attacks FDA March 28, 2008
Predictors for skin reactions to carbamazepine HC March 26, 2008
Heparin products contaminated with oversulphated condroitin sulphate: Recall to B.Braun HC March 26, 2008
Contaminated lots of PediaCol inffant colic treatment HC March 26, 2008
AneuRx Stent Graft System for abdominal aortic aneurysms: rupture risk FDA March 19, 2008
COPD treatment tiotropium (Spiriva) and possible risk of stroke FDA March 19, 2008
Additional Ephedra/Ephedrine weight loss product warnings HC March 13, 2008
Hep B treatment telbivudine (SEBIVO) and interferon: peripheral neuropathy HC March 13, 2008
HIV treatment darunavir (Prezista): hepatotoxicity FDA March 13, 2008
Erythropoiesis Stimulating Agents: increased mortality and more rapid tumour progression FDA March 13, 2008
Iron overload treatment deferasirox (Exjade): hepatotoxicity HC March 12, 2008
Cough suppressant long acting hydrocodone (Tussionex) suspension and respiratory depression in children FDA March 12, 2008
MMR vaccine lots and anaphylaxis in Alberta: no link found HC March 5, 2008
Influenza treatment oseltamivir (Tamiflu): Neuropsychiatric symptoms FDA March 5, 2008
Inhaled medications Tiotropium bromide (Spiriva) and Formoterol fumarate (Foradil): Patients swallowing capsules FDA February 29, 2008
natalizumab (Tysabri) : Liver Injury FDA February 27, 2008
Omeprazole (Losec) and Esomeprazole (Nexium): No evidence of cardiovascular risk HC February 27, 2008
New medication guide from FDA on diabetes drug rosiglitazone (Avandia) FDA February 27, 2008
Botox safety review HC February 21, 2008
Canadian fentanyl (Duragesic) patch recall HC February 20, 2008
Fentanyl (Duragesic) patch recall FDA February 20, 2008
Botox adverse reactions FDA February 13, 2008
Smoking cessation aid varenicline (Champix, Chantix): Neuropsychiatric symptoms FDA February 6, 2008
Suicidality and Antiepileptic Drugs FDA February 1, 2008
Growth factor sargramostim (Leukine) liquid withdrawn due to adverse events including syncope FDA January 25, 2008
Erythropoesis stimulating agents Aranesp, Epogen, Procrit: Worse survival and faster tumour growth FDA January 16, 2008
Bisphosphanates and severe bone pain FDA January 16, 2008
Unretrieved device fragment risk FDA January 16, 2008