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Health Professional and Public Communication
January 31, 2012
Celexa (citalopram) - Association with abnormal heart rhythms - Lundbeck Canada Inc.
Maximum doses for the antidepressant Celexa (citalopram) have been decreased and the product monograph has been updated accordingly given new cardiac safety data showing an increased risk of QT prolongation and abnormal heart rhythms at high doses.
Health Professional Communication
Public Communication
Health Professional Communication
January 31, 2012
VELCADE (bortezomib) - Fatal if Given Intrathecally - Janssen Inc.
Janssen Inc., in consultation with Health Canada, would like to alert you to the risk of fatal outcome associated with the inadvertent intrathecal administration of the antineoplastic drug VELCADE® (bortezomib).
Health Professional Communication
Notice to Hospitals
January 31, 2012
Doribax (doripenem for injection) - Higher Mortality Rate and a Lower Clinical Cure Rate Observed During a Comparative Clinical Trial - Janssen Inc.
The product monograph for Doribax will be updated to reflect findings from a study showing a higher mortality rate and a lower cure rate among patients taking Doribax 1g every 8 hours in a fixed 7-day course as compared to those taking a fixed 10-day course of imipenem-cilastatin.
Notice to Hospitals
Notice to Hospitals
January 26, 2012
Duet TRS Loading Units (Used with Endo GIA Universal Staplers and Endo GIA Universal Ultra Staplers) - Urgent Medical Device Recall - Contraindication for Thoracic Use - Covidien Canada
Covidien is conducting a voluntary recall of all production lots for the Duet TRS Universal Straight and Articulating Single Use Loading Units (SULU) with respect to the use of this product family in the thoracic cavity. Serious injuries and deaths have occurred due to the failure mode associated with this recall.
Notice to Hospitals
Foreign Products Alert
January 25, 2012
Health Canada is advising Canadians not to use these eight (8) foreign health products as they may pose a health risk. These products have been found by regulators in other countries to contain prescription, over-the-counter or unauthorized drugs, or heavy metals that are not declared on the product labels. Prescription drugs should only be taken under the supervision of a health care practitioner.
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Health Professional and Public Communication
January 24, 2012
RASILEZ (aliskiren) and RASILEZ HCT (aliskiren/hydrochlorothiazide) - Potential Risks of Cardiovascular and Renal Adverse Events in Patients with Type 2 Diabetes - Novartis Pharmaceuticals Canada Inc.
Interim study results indicate that there is an increased risk of non-fatal stroke, renal complications (end stage renal disease and renal death), hyperkalemia and hypotension in diabetic patients treated with aliskiren. The combination of aliskiren with ACE inhibitors and ARBs is now contraindicated in patients with type 2 diabetes. The Product Monograph will be updated accordingly.
Health Professional Communication
Public Communication
Information Update
January 24, 2012
UPDATE: Unauthorized Products Removed from Sale at Additional Stores in Burnaby, B.C.
Further to previous communications, Health Canada is advising Canadians that we have identified two additional Male and Female Harmony retail stores that were selling unauthorized health products. These products have been removed from sale. It is important to note that the Male and Female Harmony store located at 4554 Kingsway, Burnaby, B.C. is also known as “Love in Love Adult Store.”
Information Update
NAPRA Position Available - Manager, Professional and Regulatory Affairs
January 23, 2012
NAPRA is currently seeking a candidate to fill the position of Manager, Professional and Regulatory Affairs. For a complete position description, please visit http://niche.workopolis.com/frontoffice/seekerViewJobDetailAction.do?sitecode=pl501&jobId=1189173&page=search
Information Update
January 19, 2012
Important Reminder about Weight-loss Health Products
As the rate of obesity has increased in Canada, so has the market for weight-loss products. While authorized health products for weight loss may provide benefits when used properly as part of a weight management program, the use of unauthorized health products may pose serious risks to your health.
Information Update
Information Update
January 19, 2012
Champix: Updated safety information for the smoking-cessation drug
Health Canada is informing Canadians that our review of Champix is now complete and the label has been updated with new information with respect to cardiovascular safety. Champix (the brand name for varenicline tartrate) is a prescription drug used to help patients quit smoking in combination with supportive counselling.
Information Update
Information Update
January 17, 2012
Novartis Recall of Excedrin Products Extends to Canada
Health Canada is advising Canadians that Novartis Consumer Health Inc’s U.S. recall is now being extended to Canada. According to Novartis Consumer Health Canada Inc, the Canadian recall includes all lots (expiration dates of December 20, 2014 and earlier) for over-the-counter products, Excedrin Extra Strength Caplets and Excedrin Tension Headache Caplets.
Information Update
Canadian Adverse Reaction Newsletter
January 10, 2012
The January 2012 issue of the Canadian Adverse Reaction Newsletter published by the Marketed Health Products Directorate, Health Products and Food Branch (Health Canada) is now available. This Newsletter is a quarterly publication of adverse reaction information and provides regular feedback to health professionals on adverse reactions reported in Canada. Please consult the index for a complete listing of previous issues.
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Health Professional and Public Communication, Information Update
January 03, 2012
EpiPen and EpiPen Jr Auto-Injectors - Important Safety Information on Correct Usage - Pfizer Canada Inc.
Health Canada is informing Canadians of Pfizer Canada’s instruction for the correct use of EpiPen and EpiPen Jr., particularly the correct way to remove the blue safety caps.
Health Professional Communication
Public Communication
Information Update
Public Advisory
January 03, 2012
“Compliments Muscle and Back Pain Relief Regular Strength”:
Labelling Error May Pose Serious Risks to Children
Health Canada is advising Canadians that Vita Health’s product, “Compliments Muscle and Back Pain Relief Regular Strength” contains a significant labelling error in the French dosing directions that may pose serious risks to children (less than 12 years of age), if taken by them. According to the product label, this product is for adult use only and should not be administered to children less than 12 years of age. This product is advertised as a muscle relaxant and painkiller.
Public Advisory
Public Advisory
January 03, 2012
North American Urgent Recall: Neonatal, Pediatric and Flextend Tracheostomy Tubes
Health Canada is informing Canadians and Canadian healthcare practitioners that Smiths Medical is conducting a North American voluntary recall of certain lot numbers of Bivona Neonatal, Pediatric and Flextend Tracheostomy Tubes.
Public Advisory