Health Product InfoWatch – March 2018

Contents

• Health products mentioned in this issue
• Monthly recap
• New information
  • Case report: Combined use of the EasyCare hospital bed and over-bed table - risk of patient entrapment
• Scope
  • Reporting Adverse Reactions
• Helpful links
• Suggestions?
• Copyright

Health products mentioned in this issue

Pharmaceuticals and Biologics

• Alysena 21 and 28 (levonorgestrel and ethinyl estradiol)
• Carbocaine 2%
• Erwinase (Erwinia L-asparaginase)
• Jakavi (ruxolitinib)
• SGLT2 inhibitors
• Tecentriq (atezolizumab)
• Ventolin Diskus (salbutamol)

Medical Devices

EasyCare hospital bed

Natural Health Products

Sisu natural health products

Other

Unauthorized health products

Monthly recap of health product safety information

The following is a list of health product advisories, type I recalls as well as summaries of completed safety reviews published in February 2018 by Health Canada.

Alysena 21 and 28 (levonorgestrel and ethinyl estradiol)

Apotex Inc. recalled one lot of Alysena 28 (lot LF10133A) after complaints about chipped pink pills in sealed blister packages. Pharmacists are reminded to check each blister pack of Alysena 28 before dispensing it to make sure the pills look as they should and to report any unusual pills to Apotex Inc. and to Health Canada. Since this recall, Health Canada informed Canadians that all lots of both Alysena 21 and Alysena 28 may have chipped pills.

• Advisory - Alysena 28 (levonorgestrel and ethinyl estradiol)
• Drug recall - Alysena 28 (levonorgestrel and ethinyl estradiol)
• Advisory - Alysena 21 and 28 (levonorgestrel and ethinyl estradiol)

Carbocaine 2%

Pfizer Canada Inc. has recalled Carbocaine 2% (lot 73100DD) as vials may be cracked in the affected lot.

Drug recall - Carbocaine 2%

Erwinase (Erwinia L-asparaginase)

To help manage the impact of the ongoing shortage of Erwinase, some previously unreleased UK-labelled Erwinase vials are now being made available. These vials should be used with a standard 5-micron filter needle 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, do not administer the product and retain for collection. Healthcare professionals are reminded that there are some differences between the currently approved Canadian and UK labelling and should refer to the Erwinase Canadian product monograph for prescribing information.

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

Jakavi (ruxolitinib)

This safety review evaluated the risk of liver injury associated with Jakavi (ruxolitinib). Health Canada's review concluded that the evidence does not show a link between ruxolitinib and the risk of liver injury. The Canadian product monograph for the drug is appropriate at this time because it recommends that healthcare professionals test the patient's blood to check the liver before starting treatment with ruxolitinib and at regular periods afterward.

Summary Safety Review - Jakavi (ruxolitinib)

SGLT2 inhibitors

This safety review evaluated the risk of posterior reversible encephalopathy syndrome in patients treated with sodium-glucose cotransporter-2 (SGLT2) inhibitors (canagliflozin, dapagliflozin, empagliflozin) who had developed diabetic ketoacidosis. Health Canada's review of the available information did not find enough evidence to make a link. Health Canada encourages consumers and healthcare professionals to report any side effects related to the use of these health products.

Summary Safety Review - SGLT2 inhibitors

Sisu natural health products

Sisu Inc. recalled numerous natural health products because the glass bottles that the products are packaged in may contain glass fragments. The packaging defect was caused by a manufacturing issue involving some of the 100 mL glass bottles used in the packaging of certain Sisu products beginning in October 2015 through March 2016.

Advisory - Sisu natural health products

Tecentriq (atezolizumab)

Severe cases of myocarditis have been reported in patients being treated with Tecentriq (atezolizumab) in clinical trials. Healthcare professionals are advised to monitor patients receiving Tecentriq for signs and symptoms of myocarditis, withhold Tecentriq therapy in patients with Grade 2 myocarditis and permanently discontinue Tecentriq treatment in patients with Grade 3 or 4 myocarditis. The Canadian product monograph has been updated to include this new safety information.

Health Professional Risk Communication - Tecentriq (atezolizumab)

Unauthorized health products

Health Canada advised Canadians about various unauthorized health products being sold at retail locations across Canada or online that may pose serious health risks.

Update - Multiple unauthorized health products

Ventolin Diskus (salbutamol)

GlaxoSmithKline Inc. recalled one lot of Ventolin Diskus inhalers (lot 786G) because the products may not deliver the intended dose. Individuals who do not receive the intended dose may not be aware that the dose was not delivered.

• Advisory - Ventolin Diskus (salbutamol)
• Drug recall - Ventolin Diskus (salbutamol)