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Drugs and Health Products

Health Product InfoWatch - May 2017

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ISSN 2368-8025
Pub. no 160256

Help on accessing alternative formats, such as Portable Document Format (PDF), Microsoft Word and PowerPoint (PPT) files, can be obtained in the alternate format help section.

Health Products and Food Branch
Marketed Health Products Directorate
Health Product InfoWatch Editorial Team

Scope, reporting and contact information, helpful links

Contents

Health products mentioned in this issue

Pharmaceuticals and Biologics

Medical Devices

Other

Monthly recap of health product safety information

The following is a list of health product advisories as well as summaries of completed safety reviews published in April 2017 by Health Canada.

Avastin (bevacizumab)

This safety review evaluated the risk of non-mandibular osteonecrosis associated with Avastin (bevacizumab) in adult cancer patients. Health Canada’s review concluded that there was not enough information to establish a definitive link. However, Health Canada has recommended that the manufacturer update the Canadian product monograph (CPM) to include information of the reports of non-mandibular osteonecrosis in adult cancer patients treated with Avastin. The current CPM only mentions this risk in children treated with Avastin. Health Canada will continue to monitor safety information involving Avastin.

Summary Safety Review- Avastin (bevacizumab)

Dipeptidylpeptidase-4 (DPP-4) inhibitors

This safety review evaluated the risk of arthralgia associated with dipeptidylpeptidase-4 (DPP-4) inhibitors. Health Canada’s review concluded that there is a potential link between the use of DPP-4 inhibitors and the development of arthralgia. Health Canada is working with manufacturers to update the Canadian product monographs for all DPP-4 inhibitors to inform healthcare professionals and patients about the risk of developing arthralgia when DPP-4 inhibitors are used.

Summary Safety Review – Dipeptidylpeptidase-4 inhibitors

Direct-acting antivirals (DAAs)

This safety review evaluated the risk of liver cancer recurrence associated with direct-acting antivirals (DAAs). Health Canada’s review concluded that there was not enough information to establish a link. Health Canada has requested additional safety information from DAA manufacturers regarding this risk as it becomes available.

Summary Safety Review – Direct-acting antivirals

EpiPen (epinephrine)

Pfizer Canada recalled one lot of EpiPen auto-injector (0.3 mg/dose) and one lot of EpiPen Jr. auto-injector (0.15 mg/dose). The recalled devices may contain a defective part that may result in the auto-injector failing to activate or requiring increased force to activate.

Advisory – EpiPen (epinephrine)

Erwinase (Erwinia L-asparaginase)

To help manage the impact of the ongoing shortage of Erwinase, some previously unreleased Erwinase vials from Batch CAMR-180 were made available. These vials should be used with a 5-micron filter due to the presence of particulate matter. If particulate matter is observed elsewhere other than on the underside of the stopper (e.g., on or in the product) before or after reconstitution, the product should not be administered and should be retained for collection.

Health Product Risk Communication - Erwinase (Erwinia L-asparaginase)

Hospital beds

This safety review evaluated the risk of patient entrapment in hospital beds. Serious incidents of patient entrapment in hospital beds continue to be reported to Health Canada. Health Canada’s review concluded that it is possible to improve the safety of hospital beds by increasing the awareness of the risk of patient entrapment. Healthcare professionals are encouraged to perform a patient assessment to determine if the use of bed rails is appropriate and to closely monitor patients for whom bed rails are used. Healthcare professionals and institutions are reminded of measures to reduce the risk of patient entrapment.

Summary Safety Review – Hospital beds
Health Product Risk Communication - Hospital beds

Iodinated contrast media

This safety review evaluated the risk of hypothyroidism with Iodinated contrast media (ICM). Health Canada’s review concluded that there is a rare potential risk of hypothyroidism with the use of ICM in certain patients, mostly infants. Health Canada is working with manufacturers to update the Canadian product monographs for all ICM products to include this safety information. Health Canada has also communicated this information to healthcare professionals.

Summary Safety Review - Iodinated contrast media
Health Product Risk Communication - Iodinated contrast media

Unauthorized health product (Rhino Blitz Gold)

Testing confirmed that the unauthorized health product “Rhino Blitz Gold” contains undeclared sildenafil. The product, promoted for sexual enhancement, was seized from Stag Shop in Hamilton, Ontario.

Advisory – Unauthorized health product (Rhino Blitz Gold)

Unauthorized health products promoted for sexual enhancement

Additional unauthorized products promoted for sexual enhancement were seized from 24 Hour Adult Mart in Toronto, Ontario.

Advisory – Unauthorized health products promoted for sexual enhancement

Unauthorized health products sold online

Health Canada warned Canadians about unauthorized health products, including unauthorized prescription drugs, sold online at sarms.ca. The products were promoted for various uses, including fitness and bodybuilding.

Advisory - Unauthorized health products sold online

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