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Adverse Reactions

Doribax (doripenem for injection) - Higher Mortality Rate and a Lower Clinical Cure Rate Observed During a Comparative Clinical Trial

MedEffect Canada - Advisories and Recalls for Health Professionals - 31 January 2012 - 12:30pm
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.
Categories: Adverse Reactions

VELCADE (bortezomib) - Fatal if Given Intrathecally

MedEffect Canada - Advisories and Recalls for Health Professionals - 31 January 2012 - 9:00am
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).
Categories: Adverse Reactions

Celexa (citalopram) - Association with abnormal heart rhythms - Lundbeck Canada Inc.

MedEffect Canada - Advisories and Recalls for Health Professionals - 30 January 2012 - 3:30pm
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.
Categories: Adverse Reactions

Celexa (citalopram) - Association with abnormal heart rhythms

MedEffect Canada - Advisories and Recalls for the Public - 30 January 2012 - 1:30pm
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.
Categories: Adverse Reactions

Register of Innovative Drugs

MedEffect Canada - Advisories and Recalls for Health Professionals - 27 January 2012 - 2:15pm
A listing of drugs pursuant to sub-section C.08.004.1(9) of the Food and Drug Regulations.
Categories: Adverse Reactions

Duet TRS Loading Units (Used with Endo GIA Universal Staplers and Endo GIA Universal Ultra Staplers) - Urgent Medical Device Recall - Contraindication for Thoracic Use

MedEffect Canada - Advisories and Recalls for Health Professionals - 25 January 2012 - 4:00pm
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.
Categories: Adverse Reactions

Foreign Product Alerts

MedEffect Canada - Advisories and Recalls for the Public - 25 January 2012 - 3:45pm
17 weight loss products; Uprizing 2.0; Get Stiff, Maxi Mize; Ying Da Wang tablets; Slimina weightloss capsules, S-shape slim capsules; Athri-Eze, Sear Heang Tienchi Tu Chung Wan, Wiku Jahe Kencur (Akur Mujarab), Cap Wijaya Kusuma (An Ki It); Cardiotium, Paidusu, SlimEasy Herbs Capsule, Tianran Zuanshi Xianweisu; [LuShenPai] Specific Hou Ton Qing, [AA] Pe Min Kan Wan / 17 weight loss products; Uprizing 2.0; Get Stiff, Maxi Mize; Ying Da Wang tablets; Slimina weightloss capsules, S-shape slim capsules; Athri-Eze, Sear Heang Tienchi Tu Chung Wan, Wiku Jahe Kencur (Akur Mujarab), Cap Wijaya Kusuma (An Ki It); Cardiotium, Paidusu, SlimEasy Herbs Capsule, Tianran Zuanshi Xianweisu; [LuShenPai] Specific Hou Ton Qing, [AA] Pe Min Kan Wan
Categories: Adverse Reactions

RASILEZ (aliskiren) and RASILEZ HCT (aliskiren/hydrochlorothiazide) - Potential Risks of Cardiovascular and Renal Adverse Events in Patients with Type 2 Diabetes

MedEffect Canada - Advisories and Recalls for the Public - 23 January 2012 - 4:00pm
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.
Categories: Adverse Reactions

RASILEZ (aliskiren) and RASILEZ HCT (aliskiren/hydrochlorothiazide) - Potential Risks of Cardiovascular and Renal Adverse Events in Patients with Type 2 Diabetes

MedEffect Canada - Advisories and Recalls for Health Professionals - 23 January 2012 - 4:00pm
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.
Categories: Adverse Reactions

UPDATE: Unauthorized Products Removed from Sale at Additional Stores in Burnaby, B.C.

MedEffect Canada - Advisories and Recalls for the Public - 23 January 2012 - 12:00pm
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."
Categories: Adverse Reactions

Champix: Updated safety information for the smoking-cessation drug

MedEffect Canada - Advisories and Recalls for the Public - 19 January 2012 - 3:00pm
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.
Categories: Adverse Reactions

Important Reminder about Weight-loss Health Products

MedEffect Canada - Advisories and Recalls for the Public - 19 January 2012 - 3:00pm
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.
Categories: Adverse Reactions

Champix: Updated safety information for the smoking-cessation drug

MedEffect Canada - Advisories and Recalls for Health Professionals - 19 January 2012 - 3:00pm
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.
Categories: Adverse Reactions

Novartis Recall of Excedrin Products Extends to Canada

MedEffect Canada - Advisories and Recalls for the Public - 13 January 2012 - 11:00am
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.
Categories: Adverse Reactions
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