Health Product InfoWatch - July 2015
Pub. no 140412
Health Products and Food Branch
Marketed Health Products Directorate
Health Product InfoWatch Editorial Team
Health products mentioned in this issue
Pharmaceuticals and Biologics
- AJ-PIP/TAZ (piperacillin and tazobactam) for Injection
- Allerject (epinephrine)
- Baxter Clinimix (5% Travasol Amino Acid Injection Without Electrolytes in 16.6% Dextrose Injection)
- Forxiga (dapagliflozin)
- Invokana (canagliflozin)
- Methylprednisolone, Intravenous
- Mylan Piperacillin-Tazobactam for Injection
- NaturaLyte Liquid Sodium Bicarbonate Concentrate
- SGLT2 Inhibitors (Forxiga and Invokana)
- Tecfidera (dimethyl fumarate)
This monthly publication is intended primarily for healthcare professionals and includes information on pharmaceuticals, biologics, medical devices and natural health products. It provides a summary of key health product safety information published in the previous month by Health Canada, as well as a selection of new health product safety information meant to raise awareness. New information contained in this issue is not comprehensive but rather represents a selection of clinically relevant items warranting enhanced dissemination.
Reporting Adverse Reactions
Canada Vigilance Program
For more information on how to report an adverse reaction, visit the Reporting Adverse Reactions to Drugs and Other Health Products page.
Monthly recap of health product safety information
AJ-PIP/TAZ (piperacillin and tazobactam) for Injection
Three lots of AJ-PIP/TAZ (piperacillin and tazobactam) for Injection, 4 g/0.5 g by Jamp Pharma Corporation were recalled due to the potential presence of particulate matter.
Two lots of Allerject (0.15 mg/0.15 mL auto-injector) were recalled due to a manufacturing defect with the needle. As a result, the device may not deliver the epinephrine.
Baxter Clinimix, 5% Travasol Amino Acid Injection Without Electrolytes in 16.6% Dextrose Injection
Baxter recalled 3 lots of Clinimix, 5% Travasol Amino Acid Injection Without Electrolytes in 16.6% Dextrose Injection 1L due to particulate matter found in the solution.
Body Bentonite Unique Healing Powder by Donna Pessin
Health Canada advised Canadians not to use this foreign health product as it was found to contain high levels of metals, which may pose serious health risks. This product is not authorized for sale in Canada and has not been found in the Canadian marketplace but it is possible it may have been brought in the country by travellers or purchased over the Internet.
Drugs from Hospira S.P.A.
Health Canada is restricting the importation of drugs from Hospira S.P.A. in Liscate, Italy, due to data integrity concerns. This measure was taken to help mitigate any potential risk in light of recent findings that raised concerns about the reliability of the laboratory data generated at this site. Health Canada has compiled a list of marketed products affected by the importation restrictions and will update it as new information becomes available.
This safety review was initiated following the identification of 28 published international cases of liver injury associated with intravenous methylprednisolone. Health Canada concluded there was evidence of an association between intravenous methylprednisolone and the occurrence of liver injury with a variable time to onset. The Canadian prescribing information for Solu-Medrol and Solu-Medrol Act-O-Vials has been updated to better reflect the available evidence regarding the risk of liver injury. Manufacturers of generic versions will also update their product information.
Mylan Piperacillin-Tazobactam for Injection
One lot of Piperacillin-Tazobactam for Injection, 3 g/0.375 g and one lot of Piperacillin-Tazobactam for Injection, 4 g/0.5 g were recalled by Mylan Pharmaceuticals ULC, due to the potential presence of particulate matter.
NaturaLyte Liquid Sodium Bicarbonate Concentrate
One bottle of NaturaLyte Liquid Bicarbonate Concentrate from a lot which was not distributed in Canada had bacterial contamination. The possibility that other lots manufactured in 2015 may be affected cannot be excluded.
Quarantined Health Products - Polydrug Laboratories
Health Canada has requested that Canadian importers voluntarily quarantine drug products with active pharmaceutical ingredients (APIs) manufactured or tested by Polydrug Laboratories, in Ambarnath, Maharashtra, India, due to data integrity concerns.
Quarantined Health Products - Zhejiang Hisun Pharma
Health Canada has requested that Canadian importers voluntarily quarantine drug products with active pharmaceutical ingredients (APIs) manufactured or tested by Zhejiang Hisun Pharma Company Ltd., in Zhejiang, China, due to data integrity concerns.
SGLT2 Inhibitors Forxiga and Invokana
Health Canada initiated a safety review for the prescription diabetes drugs dapagliflozin (Forxiga) and canagliflozin (Invokana) and the risk of ketoacidosis. Health Canada will review the available information and will determine whether changes are needed in the prescribing information for this class of drug.
Sport X Ephedrine, DHEA 25 and Promatrix DHEA 25
Three unauthorized health products that may pose serious risks to the health of Canadians were seized by Health Canada. The products “Sport X Ephedrine”, “DHEA 25” and “Promatrix DHEA 25” were being sold by S&H Health foods on Burnhamthorpe Rd. W., in Mississauga.
Tecfidera (dimethyl fumarate)
This safety review evaluated the potential risk of hypersensitivity reactions associated with Tecfidera (dimethyl fumarate). Health Canada concluded that the overall benefits of Tecfidera continue to outweigh the risks when used as recommended. The Canadian prescribing information for Tecfidera was updated to provide information concerning hypersensitivity reactions, including angioedema and anaphylaxis, as well as severe flushing reactions.
Unauthorized Health Products from Better Bodies Supplements
Health Canada informed Canadians that 8 unauthorized health products were seized from Better Bodies Supplements on Main Street North, in Airdrie, Alberta. These products were also available for purchase from the retailer’s online store "Better Bodies Nutrition". These products contain a combination of ingredients (synephrine/ephedrine/ephedra, caffeine and L-dopa) that can cause serious health risks.
Your comments are important to us. Let us know what you think by reaching us at InfoWatch_InfoVigilance@hc-sc.gc.ca
Marketed Health Products Directorate
Address Locator 0701D
Ottawa ON K1A 0K9
© 2015 Her Majesty the Queen in Right of Canada. This publication may be reproduced without permission provided the source is fully acknowledged. The use of this publication for advertising purposes is prohibited. Health Canada does not assume liability for the accuracy or authenticity of the information submitted in case reports.
Adverse reactions (ARs) to health products are considered to be suspicions, as a definite causal association often cannot be determined. Spontaneous reports of ARs cannot be used to estimate the incidence of ARs because ARs remain underreported and patient exposure is unknown.
Due to time constraints relating to the production of this publication, information published may not reflect the most current information.
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