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SAFETY BULLETINS

March 8, 2018

Further to a recent advisory about the recall of one lot of Alysena 28 birth control pills because of chipped pills, Health Canada is informing Canadians that all lots of both Alysena 21 and Alysena 28 may have chipped pills. Health Canada is reminding women to always check their pills carefully before taking them.

Alysena 21 and Alysena 28 are prescription drugs used to prevent pregnancy as well as to treat acne (in women 14 or more years of age). Alysena 21 contains 21 “active” pink pills, while Alysena 28 contains 21 “active” pink pills and 7 “inactive” white pills.

March 14, 2018

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. Permanently discontinue TECENTRIQ treatment in patients with Grade 3 or 4 myocarditis. Administer corticosteroids and/or additional immunosuppressive agents as clinically indicated to TECENTRIQ treated patients who develop myocarditis. The Canadian Product Monograph has been updated to include this new safety information.

March 16, 2018
 

Health Canada is advising Canadians that two versions of the sexual enhancement product “Leopard Miracle of Honey” may pose serious health risks. Both versions are labelled as being approved by Health Canada, with NPN 80073650. Health Canada’s testing found that both versions of the product contain the undeclared prescription drug sildenafil. The product was not authorized to contain this prescription drug. Health Canada seized the products from two Ontario convenience stores located in Woodbridge, ON, and suspended the product licence.

February 12, 2018
 

Health Canada advises of a recall by Pfizer of Carbocaine 2%. Reason: Vial may be cracked in affected lot.

Depth of distribution: Wholesalers and hospitals across Canada. Affected products: Carbocaine 2%.

February 14, 2018
 

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. Permanently discontinue TECENTRIQ treatment in patients with Grade 3 or 4 myocarditis. Administer corticosteroids and/or additional immunosuppressive agents as clinically indicated to TECENTRIQ treated patients who develop myocarditis. The Canadian Product Monograph has been updated to include this new safety information.

February 22, 2018
 

Health Canada is advising Canadians that Sisu Inc. has voluntarily recalled numerous natural health products because the glass bottles that the products are packaged in may contain glass fragments, which may pose serious health risks if ingested or handled.

January 25, 2018

On January 25, 2018, Aphria initiated a voluntary Type III recall for two lots of dried marijuana sold in 10 g bottles, due to a labelling error. The labels omitted to indicate the percent sign (%) next to the numerical values for cannabinoid content.

A Type III recall refers to a situation in which the use of, or exposure to, a product is not likely to cause any adverse health consequences.

To date, Health Canada has not received any adverse reaction reports for products sold by Aphria. However, Health Canada recommends that any individual affected by the recall immediately stop using the recalled product and contact Aphria at the following number 1-844-427-4742.

January 17, 2018

These foreign health products have been found by regulators in other countries to contain undeclared drug ingredients.

The products are not authorized for sale in Canada and have not been found in the Canadian marketplace, but it is possible they may have been brought into the country by travellers or purchased over the Internet. Adipessum Miracle Slimming Capsules, Beautiful Lose Weight, Blue Pearl All Natural Male Enhancement pill, Chong Cao Dan pills, Fruta Planta Life capsules, Hard Rod Plus capsules, Hard Times for Men capsule, Linsen Double Caulis Plus capsules, Lishou Fuling Jiaonang, Lose Weight 30, Red Ant, Super Soniic capsules, Wan Ling Ren Sem Chin Kuo Pill.

January 25, 2018

Health Canada is advising Canadians that it has seized several health products, including one kratom and 16 sexual enhancement products, from multiple George’s convenience stores located in the Greater Toronto Area (Brampton, Maple, Markham and Woodbridge). These products are not authorized by Health Canada and may pose serious health risks. Stop using these products. Consult your health care professional if you have used these products and have health concerns, and for advice on which health products are best for you and your family.

Read product labels to verify that health products have been authorized for sale by Health Canada. Authorized health products have an eight-digit Drug Identification Number (DIN), Natural Product Number (NPN) or Homeopathic Drug Number (DIN-HM). You can also check if products have been authorized for sale by searching Health Canada’s Drug Product Database and Licensed Natural Health Product Database.

December 22, 2017

Health Canada is advising Canadians and healthcare professionals that new safety warnings will be added to the product safety information of the following sedative and anesthetic drugs when they are used in early childhood and during pregnancy: Diprivan (propofol), Ketalar (ketamine), Sevorane (sevoflurane), Suprane (desflurane), Forane/Isoflurane USP (isoflurane), Ativan (lorazepam), midazolam, phenobarbital and thiopental. The Department conducted two reviews to assess the potential risk of adverse effects on the development of children’s brains when certain sedative and anesthetic drugs are used in pregnancy or in early childhood.

December 22, 2017 Unauthorized product alert: Ultra Pure Colloidal Silver health risks Health Canada is advising Canadians, especially children and pregnant women, not to use the unauthorized product Ultra Pure Colloidal Silver by ECG Naturals because it may pose a serious risk to health. Consumers taking this product are at risk of developing a condition called generalized argyria, which is the permanent bluish-gray discolouration of the skin, eyes and nails. At this time, there is no scientific evidence that supports the use of colloidal silver for any specific disease or condition in humans. The product may have been sold at retail stores across Canada.
January 11, 2018 Drug Alert: Risk of drug-induced liver injury for nintedanib (OFEV) Cases of drug-induced liver injury (DILI), including one fatal outcome, have been reported in patients treated with OFEV (nintedanib). In most of these cases, the DILI was reversible when the dose was reduced or treatment was stopped. The majority of the cases occurred within the first three months of starting OFEV. Therefore, particular attention is recommended during this initial period. Healthcare professionals are advised to monitor patients’ liver transaminases and bilirubin levels: just before starting treatment; at regular intervals (e.g., monthly) during the first three months of treatment; and periodically thereafter (e.g., at each patient visit) or as clinically indicated. Healthcare professionals are reminded that: If the transaminase (AST or ALT) levels are greater than three times the upper limit of normal (ULN), OFEV dosage should be reduced or treatment interrupted. OFEV therapy should be permanently discontinued if any liver test elevations are associated with clinical signs or symptoms of liver injury (e.g., jaundice). Health Canada is working with the manufacturer to include this safety information in the Canadian Product Monograph.
November 16, 2017 Recall: Cannabis for Medical Purposes On November 16, 2017, Aurora Cannabis Enterprises Inc. initiated a voluntary Type II recall for one lot of Sundance borealis blend (sativa), sold in 5 g bottles, due to an error in packaging of the product. The delta-9-tetrahydrocannabinol (THC) content identified on the label was higher and the cannabidiol (CBD) content identified on the label was lower than the concentration present in the product. For lot 17-118-2042, the products packaged contained a THC value of 16.2% instead of 8.17% THC, and a CBD value of 0.05% instead of 5.91% CBD. A Type II recall refers to a situation in which the use of, or exposure to a product may cause temporary adverse health consequences, or where the probability of serious adverse health consequences is remote.
November 17, 2017 Unauthorized product alert: Multiple sexual enhancement products Health Canada is advising Canadians about unauthorized health products that may pose serious health risks. The table is updated when Health Canada finds unauthorized health products that are promoted for sexual enhancement, weight loss, as a workout aid, or as “poppers,” and that are labelled to contain or have been tested and found to contain dangerous ingredients. Unauthorized health products have not been approved by Health Canada, which means that they have not been assessed for safety, effectiveness and quality. Unauthorized health products can pose many health dangers.
Nov 24, 2017 Advisory: Breast Implants: Risk of Lymphoma Healthcare professionals including family physicians, obstetricians and gynaecologists, oncologists, general pathologists and hematopathologists, hematologists, radiologists, general and plastic surgeons. Rare cases of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) have been reported in Canada and internationally. Available data, from literature and international regulators, suggest that BIA-ALCL occurs more frequently following implantation of breast implants with textured surfaces compared to those with smooth surfaces. Healthcare professionals are encouraged to learn more about the signs, symptoms and testing steps to recognize and diagnose BIA-ALCL. Health Canada is working with manufacturers to update this safety information on the product labelling for breast implants.