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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.

2010 | 2009 | 2008 | 2007 | 2006 | 2005 | 2004 | 2003

 Advisory From Date posted
Topical hemostatic agents: air/gas embolism associated with with delivery using spray devices HC August 27, 2010
Recall of some Huber needles: risk of coring FDA August 27, 2010
Shared use of finger-stick devices to obtain blood specimens: risk of transmitting blood-borne pathogens FDA August 27, 2010
Recall of two lots of GlucaGen Hypokit: manufacturing defect in syringes HC August 27, 2010
Recall of Mr. Magic Male Enhancer: contains undeclared drug ingredient (analogue of sildenafil) FDA August 27, 2010
Recall of Inomax (nitric oxide) Drug-Delivery System: potential for failure of pressure switch FDA August 27, 2010
Association of bevacizumab with hypersensitivity and infusion reactions HC August 27, 2010
Tilt standing frames: risk of injury if instructions not followed HC August 27, 2010
Stalevo (combination of carbidopa/levodopa and entacapone): may increase risk for cardiovascular events FDA August 27, 2010
"Male Enhancement ExtenZe" and "Women ExtenZe": contain undeclared prescription ingredients HC August 27, 2010
Comecoo and Zhongcaoyao-Jiankangjianfei: Contain undeclared phenolpthalein, sibutramine, and substances similar to subutramine HC June 16, 2010
Qingzhi Santian Shou: Contains undeclared sibutramine, and substance similar to subutramine HC June 16, 2010
Vita Breath: May contain hazardous levels of lead
HC June 16, 2010
Unauthorized products with labelling only in Russian, Ukrainian or Kazakh languages may pose serious health risk HC June 15, 2010
Liquid vitamin D supplements: Some sold with droppers that could allow harmful amounts to be dispensed FDA June 15, 2010
Recall of caspofungin acetate for injection (Cancidas): Cracked vials HC June 15, 2010
Baxter Colleague volumetric infusion pumps: Acceptable for use with the latest upgrade HC June 11, 2010
Recall of ciprofloxacin injection (BioSyent Pharma): Particulate matter HC June 11, 2010
Vigofit and Once More: Contain undeclared sildenafil HC June 11, 2010
Unauthorized OM Fusion products: Contain undeclared prescription ingredients HC June 11, 2010
Unauthorized products seized in Burnaby BC: Contain undeclared prescription ingredients HC June 11, 2010
RISPERDAL CONSTA (risperidone powder for injectable prolonged-release suspension): Risk of needle detachment HC June 11, 2010
Varenicline tartrate (Champix): Risk of neuropsychiatric and hypersensitivity adverse events HC June 11, 2010
Olmesartan (Benicar): Review of possible association with higher rate of death from cardiovascular causes FDA June 11, 2010
Recall of Liposyn and propofol products (Hospira): Injectable products may contain particulate matter FDA June 11, 2010
Recall of Defibtech DBP-2800 Battery Packs used in Lifeline AED and ReviveR AED: Charge may be cancelled erroneously FDA June 11, 2010
Recall of GammaGard Liquid (Human immune globulin intravenous): Reports of allergic reactions FDA June 11, 2010
Recall of intravenous medications from Claris (metronidazole, ciprofloxacin and ondansetron): Contamination of products FDA June 11, 2010
Recall of Hylenex recombinant (hyaluronidase human injection): Particulate matter (glass) observed in vials FDA June 11, 2010
Orlistat (Alli and Xenical): Rare reports of severe liver injury FDA June 11, 2010
Proton pump inhibitors: possible increased risk of fractures of hip, wrist, and spine FDA June 11, 2010
Tramadol hydrochloride (Ultratram), tramadol hydrochloride/acetaminophen (Ultracet)): Increased risk of suicide, overdose and abuse FDA June 11, 2010
Varenicline tartrate (Champix): Changes to the Canadian monograph (neuropsychiatric, skin and allergic adverse events) HC June 3, 2010
Recall of 4 Pediacare children's products: Manufacturing plant cited by FDA for deficiencies FDA June 3, 2010
Botanical Slimming 100% Natural Soft Gel (also sold as Meizitang) contains undeclared sibutramine HC May 19, 2010
Marsha Slim Plus contains undeclared sibutramine HC May 19, 2010
S&S Super Slender contains undeclared substances (including sibutramine and phenolphthalein) HC May 19, 2010
Recall of Metronidazole injection 500 mg / 100 ml (Claris Life Sciences, Sagent): Non-sterility of some lots FDA May 19, 2010
Maalox Multi Action (bismuth subsalicylate): Confusion with other Maalox liquid products HC May 17, 2010
Natalizumab (Tysabri): Association with progressive multifocal leukoencephalopathy (updated safety information) HC May 17, 2010
Rotarix and RotaTeq vaccines: Appropriate to resume or continue use of these vaccines FDA May 17, 2010
Summary of recent drug safety labelling changes FDA May 17, 2010
Recall of some cuffed Shiley tracheostomy products (Tyco Healthcare Canada): Air leak could affect ventilation HC May 17, 2010
Eltrombopag (Promacta): Portal venous system thromboses in study of patients with chronic liver disease FDA May 17, 2010
Recall of some GE Healthcare Aisys and Avance Anesthesia Systems: Machine may shut down unexpectedly FDA May 17, 2010
Benadryl Extra Strength Itch Stopping Gel: Packaging changes to reduce ingestion of topical product FDA May 17, 2010
Adverse reactions to Miracle Mineral Solution for treating drinking water: Contains 28% sodium chlorite HC May 13, 2010
Exelon Patch (rivastigmine transdermal patch): Serious adverse events related to errors or misuse of patch HC May 10, 2010
Foreign products alert May 2010 HC May 10, 2010
Rotarix and RotaTeq vaccines: concerns over presence of porcine viruses HC May 10, 2010
Recall of Teleflex Medical AQUA+FLEX Hygroscopic Condenser Humidifier: possibility of disconnection from endotracheal tube FDA May 10, 2010
Vivitrol (naltrexone for extended-release injectable suspension): medication guide required for patients about risk of severe injection site reactions FDA May 10, 2010
Recall of all Baxter Colleague Volumetric Infusion Pumps FDA May 10, 2010
GnRH Agonists for prostate cancer: Possible increased risk of diabetes and certain cardiovascular diseases FDA May 10, 2010
Vita Breath dietary supplement: May contain hazardous levels of lead FDA May 10, 2010
Recall of McNeil Consumer Healthcare over-the counter products for infants and children (Tylenol, Motrin, Zyrtec and Benadryl): May not meet required standards FDA May 3, 2010
Unapproved product Slim-30 (Duxx Enterprises) contains undeclared drug similar to sibutramine HC April 30, 2010
Expanded recall of Cardiac Science Automated External Defibrillators (Powerheart, Cardiovive, NK, Responder models): Electrical component defects FDA April 30, 2010
Updated prescribing information for promethazine hydrochloride injection: use in children and route of administration HC April 26, 2010
Recall of certain Shiley tracheostomy tubes: Leaks in cuff FDA April 26, 2010
Recall of LIFEPAK 15 Monitor/Defibrillator (by Physio-Control Inc.): Risk of malfunction of power controls FDA April 23, 2010
Propylthiouracil: reports of severe liver injury and acute liver failure FDA April 22, 2010
Summary of recent drug labelling changes FDA April 22, 2010
Association of saquinavir mesylate (Invirase) with dose-dependent prolongations of QT and PR intervals HC April 22, 2010
Discontinuation of sale of ceftobiprole medocaril (Zeftera) for injection HC April 22, 2010
New expiry date for unused H1N1 Vaccine (Arepanrix) HC April 22, 2010
Changes to dose-conversion guidelines for Fentanyl Transdermal Systems HC April 22, 2010
Unapproved product "Power-Max" contains undeclared sildenafil HC April 22, 2010
Recall of Stud Capsule For Men: Product adulterated with sildenafil FDA April 8, 2010
Recall of Camolyn eye drops: Product may not be not sterile FDA April 8, 2010
Recall of Fisiolin nasal drops: Product may not be not sterile FDA April 8, 2010
The unauthorized product "West Pharm Therma Lean Fat Burner Energizer" contains ephedrine and caffeine HC April 6, 2010
Stalevo (entacapone/carbidopa/levodopa) may increase the risk of developing prostate cancer HC April 6, 2010
MasXtreme Capsules (Natural Wellness) contains undeclared aildenafil (similar to sildenafil) HC April 6, 2010
Herbal Diet Natural contains a pharmaceutical ingredient similar to sibutramine HC March 25, 2010
WinRho SDF [Rho(D) immune globulin (human)]: Association with intravascular hemolysis in treatment of immune thrombocytopenic purpura HC March 25, 2010
Recall of Ratio-Prednisolone 1% ophthalmic solution: Several lots may contain irritating particles HC March 24, 2010
Recommendation to suspend use of Rotarix vaccine: Porcine circovirus type 1 is present in vaccine FDA March 23, 2010
Recall of Becton, Dickinson (BD) Q-Syte Luer Access Split Septum device: Air bubbles may leak into infusion system FDA March 22, 2010
Risk of severe liver injury with moxifloxacin HC March 22, 2010
Increased risk of muscle injury with high doses of simvastatin, especially when used with certain drugs FDA March 22, 2010
Recall of Boston Scientific implantable cardioverter defibrillators: FDA must approve changes by manufacturer prior to use FDA March 22, 2010
Recall of clevidipine butyrate: Presence of steel particles in emulsion (additional lots recalled) FDA March 18, 2010
Recall of OneTouch SureStep test strips: low test results when blood glucose is greater than 22.2 mmol/L HC March 18, 2010
Recall of Gyrus ACMI Micron Bobbin Vent Tube T: Device implanted for ventilation or drainage of the middle ear is not sterilized FDA March 18, 2010
Recall of Teleflex Arrow IV tubing sets, accessories, and embolectomy catheters: product sterility may be compromised FDA March 16, 2010
Recall of Baylis Medical Torflex Transseptal Guiding Sheath: tip may break off during procedures FDA March 16, 2010
Recall of Abiomed AB5000 Circulatory Support System: Device computer may shut down without an alarm FDA March 15, 2010
Ongoing review has not shown clear connection between oral bisphosphonates and risk of atypical subtrochanteric femur fractures FDA March 15, 2010
Recall of Beckman Coulter UniCel DxC Synchron Clinical System - Ion Selective Electrode Flow Cell: Incorrect sodium results FDA March 15, 2010
Summary of recent drug safety labelling changes FDA March 15, 2010
Clopidrogel: Reduced effectiveness in patients who are poor metabolizers of the drug FDA March 15, 2010
Counterfeit polypropylene surgical mesh FDA March 15, 2010
Reminder to check medical device clocks after switch to daylight savings time HC March 15, 2010
Recall of Baxter HomeChoice and HomeChoice PRO Automated Peritoneal Dialysis Systems: Reports of serious injuries and death associated with increased intraperitoneal volume FDA March 8, 2010
Recall of Thomas Medical Products Transseptal Sheath Introducer Kits: sheath tip may break off FDA March 8, 2010
2H &D: Contains undeclared tadafil HC March 2, 2010
STRO Emperor capsules: Some lots contain undeclared tadalafil HC March 2, 2010
Tian Yan Xu Huo oral ulcer capsule: One lot contains undeclared aristolochic acid HC March 2, 2010
Products distributed by Bodybuilding.com: May contain anabolic steroids HC March 2, 2010
Products distributed by Atlas Operations Inc: May contain undeclared sulfoaildenafil HC March 2, 2010
Recall of StatSpin Express 4 centrifuges: Rotor may break and eject pieces FDA March 1, 2010
Recall of OneTouch SureStep test strips: May provide falsely low results when glucose level is over 22 mmol/L FDA March 1, 2010
Association between zinc-containing Poli-Grip products and myeloneuropathy/blood dyscrasias HC February 24, 2010
Saquinavir: Possible association with abnormal heart rhythms when used in combination with ritonavir FDA February 23, 2010
Rosiglitazone (Avandia): Review of new trial data on cardiovascular safety FDA February 23, 2010
Risk of serious injuries with ear candles FDA February 22, 2010
OM Fusion Distributors LLC health products may cause life-threatening reactions HC February 22, 2010
Recall of Nipro GlucoPro Insulin Syringes: needles may detach HC February 22, 2010
Long-Acting Beta-Agonists (LABAs): New safe use requirements FDA February 22, 2010
Deferasirox (Exjade): Risk of renal impairment/failure, hepatic impairment/failure or gastrointestinal hemorrhage FDA February 18, 2010
Maalox Total Relief should not be used by those with history of GI ulcers or bleeding disorders (contains bismuth subsalicylate) FDA February 18, 2010
Accutane: Association with severe skin reactions HC February 16, 2010
Recall of NeXus I, II and III Rollators: Walkers associated with risk of falls and serious injury HC February 11, 2010
Recall of Cardiac Science automated external defibrillators (Powerheart, Cardiovive, CardioLife models): May fail during cardiac resuscitation attempts FDA February 10, 2010
Recall of BD Q-Syte Luer access devices: May cause air embolism or leakage FDA February 10, 2010
Recall of “Complete 7-Day Cleanse”: may cause dehydration and electrolyte imbalances HC February 9, 2010
Tysabri (Natalizumab): Risk of developing progressive multifocal leukoencephalopathy (PML) increases with the number of infusions received FDA February 5, 2010
Complications associated with transvaginal implantation of surgical mesh for treating stress incontinence and pelvic organ prolapse HC February 5, 2010
Recall of Safesheath CSG Coronary Sinus Guide Hemostatic Introducer System: Sheath tip may break off
FDA February 5, 2010
Unauthorized Natural Choice products in Canadian market (Vitamin B-17, Kava Kava and Lithium Orotate) HC February 2, 2010
Products containing glucomannan may cause serious choking if taken with insufficient liquid HC February 2, 2010
Recall of Hettich centrifuges with plastic rotors: risk of ejection of hematocrit rotor FDA February 2, 2010
Recall of Edwards Lifesciences Aquarius Hemodialysis System: clinically significant fluid imbalance and potential for users to override the fluid imbalance alarm FDA February 2, 2010
Videx/Videx EC (didanosine): Risk of non-cirrhotic portal hypertension FDA February 2, 2010
Zyprexa (olanzapine): Consider potential long-term risks when prescribing to adolescents FDA February 2, 2010
Availability of medications for Parkinson Disease HC January 28, 2010
Velcade (bortezomib): starting dose adjustments for patients with hepatic impairment FDA January 26, 2010
Recall: Exel/Exelint infusion sets and needles may cut slivers in access ports FDA January 26, 2010
Alli 60 mg capsules : counterfeit product contains undeclared drug (sibutramine) in up to 3 times the usual daily dose FDA January 25, 2010
Recall of Nipro GlucoPro insulin syringes FDA January 22, 2010
Sibutramine not to be used in patients with history of cardiovascular disease FDA January 22, 2010
Recall of TYLENOL® Arthritis Pain Caplet 100 count bottles with red EZ-OPEN CAP (purchased in USA) HC January 19, 2010
Recall of BiCNU (carmustine for injection): risk of infection HC January 19, 2010
Recall: Flaw in Trailblazer Support Catheter FDA January 19, 2010
Foreign product alerts Jan 2010 HC January 19, 2010
Rapamune (sirolimus): Changes in drug monitoring FDA January 19, 2010
Recall of Rolaids Antacid tablets packaged in bottles HC January 18, 2010
Counterfeit Alli 60 mg (sibutramine) capsules (120 count refill kit) FDA January 18, 2010
"The Slimming Coffee" and "Lose Weight Coffee" contain sibutramine HC January 18, 2010
"Stiff Nights" contains sildenafil HC January 18, 2010
OPTIMARK (gadoversetamide injection) — Association with Nephrogenic Systemic Fibrosis in Patients with Renal impairment HC January 18, 2010
MuscleMaster(dot)com dietary supplements recalled (may contain steroids) FDA January 18, 2010
Recall of McNeil Consumer Healthcare OTC products FDA January 18, 2010