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SAFETY BULLETINS

August 25, 2016


REVOLADE administration can cause severe hepatotoxicity and potentially fatal liver injury. Cases of severe drug-induced liver injury with REVOLADE have been reported in patients during clinical trials and post-marketing.

To mitigate the risk of severe hepatotoxicity and potentially fatal liver injury, healthcare professionals should: measure serum alanine aminotransferase (ALT), aspartate aminotransferase (AST) and bilirubin prior to initiation of REVOLADE, every 2 weeks during the dose adjustment phase, and then monthly following establishment of a stable dose. Discontinue REVOLADE if ALT levels: increase greater than or equal to 3x upper limit of normal (ULN) in patients with normal liver function or; increase greater than or equal to 3x baseline or greater than 5x ULN, whichever is the lower, in patients with elevations in transaminases before treatment.

The Canadian Product Monograph for REVOLADE has been updated to reflect this new safety information.

August 24, 2016


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.

King-Wolf Tablets, MAGNA-RX Capsules, My Steel Woody, Black Storm tablets, 4L Slimness and 4L Slimburn Plus, Dream Body 450mg, Dream Body Advanced 400mg, Dream Body Advanced + Acai Weight Loss & Cleanse, Dream Body Original Formula, Dream Body Extreme Gold, SBF Bee Pollen, Extra Slim Plus Acai Berry Weight Loss Formula, Lose Weight Coffee, TANGKE TEGONGYIHAOJIAONANG

August 15, 2016


A. MYGO LECKEY Wheelchair Stander. This correction (field safety corrective action) has been instigated by James Leckey Design Ltd. because it is believed there is a remote risk of a hand/wrist injury to staff adjusting the angle of the Mygo Stander from a horizontal to a vertical position. This risk can be eliminated through a simple correction.

August 5, 2016

Health Canada is advising Canadians that Pharmascience Inc. has initiated a voluntary recall of one lot of pms-Atenolol 100 mg, used to treat cardiovascular conditions such as hypertension (high blood pressure), due to a labelling error. The lot contains foil blister packs incorrectly labelled as pms-Atenolol 50 mg with the wrong Drug Identification Number (DIN). The information on the outer package is correct.

The labelling error could result in a patient taking a double dose of the product. This could result in excessively low blood pressure and decreased heart rate, particularly in elderly patients and patients with impaired kidney function, which may cause dizziness, fainting and falling. Other symptoms could include drowsiness, tiredness, nausea and diarrhea.

August 3, 2016

Health Canada is advising consumers not to use the unauthorized weight loss product AlgoSlim, distributed via mail order by E Sélection. The package does not contain unauthorized AlgoSlim and instead contains an authorized product, Slite-T, from a lot that expired in June 2012.

The product labelled as AlgoSlim contains ingredients not listed on the label (Camellia sinensis leaf and Garcinia cambogia). Consumers should also be aware that the following cautions and warnings for the authorised Slite-T product are hidden by the unauthorized AlgoSlim product labelling:

"Consult a health care practitioner before using the product if you are pregnant or breastfeeding. Consult a health care practitioner before using if you have an iron deficiency or if you have liver problems or if you show symptoms of liver problems." Health Canada is following up and will inform Canadians should any new safety information arise.

July 29, 2016

Health Canada is advising Canadians not to use an additional Personnelle sunscreen lotion (see below) because of microbial contamination. The affected sunscreen lotions were sold at Jean Coutu retail locations.

The sunscreen lotions were found to contain Lactobacillus brevis and Micrococcus luteus. Although Lactobacillus brevis does not cause any illness in humans, Micrococcus luteus may cause various infections including skin infections and occasionally serious problems, such as meningitis, septic shock (dangerously low blood pressure in response to an infection), septic arthritis (infection in a joint usually caused by bacteria), pneumonia endocarditis (inflammation of the lining of the heart valves most often caused by infection), or sepsis (a potentially life-threatening complication of an infection). The risk may be higher for children and individuals with a weakened immune system.

March 24, 2016

Health Canada is informing Canadians that it has requested Empack Spraytech Inc to initiate a recall of one lot of sunscreen lotion (see below) because of microbial contamination. The affected sunscreen was sold at Jean Coutu retail locations. Microbial contamination may result in a skin infection. The risk may be increased in children and individuals with a weakened immune system.

Consumers should check to see if they have purchased the sunscreen lotions as the products should not be used. Health Canada will monitor Empack Spraytech Inc’s recall and will inform Canadians if new safety information arises. Consumers should consult their health-care practitioner with any questions or concerns regarding the use of this sunscreen products.

March 24, 2016

In Canada, the flu (influenza) season typically runs from November to April. However, according to the Public Health Agency of Canada, the flu season was late to begin in Canada this year, and we are only now heading into peak season. Over the past few weeks, the number of Canadians, including children, who are sick with the flu has continued to increase.

Health Canada is reminding Canadians that over-the-counter cough and cold medicines should not be given to children under the age of 6.

In 2009, Health Canada conducted a review and determined over-the-counter cough and cold products in children have not been shown to be effective. In addition, serious harm, including misuse, overdose and side-effects may occur in children under 6 years of age when using over-the-counter cough and cold products, although the risk of such serious harm is low. Despite recommendations and labelling on these products, recent reports indicate that children under 6 are still being given cough and cold medications by parents or caregivers.

March 29, 2016

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.

The products are: Lipo Escultura, 100% healthy food for men tablets, Blue Diamond capsules, Diamond 3500, Eros Power Zone 1900, OrgaZen 3500, Rhino 7 Blue 9000, Rhino Big Horn 3000, Triple MiracleZen Extreme 1750 mg, Triple MiracleZen Gold 1750 mg, Triple MiracleZen Plus 1500 mg, Triple Power Zen Gold 2000, Triple Power Zen Plus 2000, V-MAX Herbal Tablets, Xtra Zone 2200, Xtra Zone 2400, Xtra Zone

December 23, 2015

Health Canada is informing Canadians that five unauthorized drugs that may pose serious risks were seized from retailers in B.C. and Ontario. The products were seized because they were labelled to contain prescription drugs, narcotic or found to contain a prescription drug that was not listed on the label: Mega Power, Biseptol, Naproxen Emo, Oxycort, and Herba Pini Syrop.

Drugs that contain prescription drug ingredients should only be taken under the supervision of a health professional because they are used to treat specific diseases, and may cause serious side effects. Unauthorized drugs have not been approved by Health Canada which means that they have not been assessed for their safety, effectiveness and quality. As a result, they may contain ingredients not listed on the label, other additives and/or contaminated ingredients. In addition, unauthorized drugs may lack the active ingredients Canadians would expect to help maintain and improve health or contain other ingredients that may interact with other medications and foods. For all of these reasons, these products could cause serious health effects.

December 18, 2015

Health Canada is advising Canadians that several clinics in Ontario and at least one in Québec are currently using illegally imported medical devices, Cryosaunas, which are potentially linked to a death in the US. Cryosaunas use liquid nitrogen to expose users to cold air (at or below -200-300°F) for several minutes for the purpose of "whole body therapy".

December 10, 2015

Health Canada is advising Canadians that the use of over-the-counter acne products applied to the skin containing benzoyl peroxide or salicylic acid may cause rare but serious allergic reactions. Signs and symptoms of a serious allergic reaction called hypersensitivity reaction may include itchy hives with swelling of the face, eyes, lips, mouth or throat; difficulty breathing; throat tightness or hoarseness; and/or fainting. A type of hypersensitivity reaction called anaphylactic reaction can come on quickly and is potentially life-threatening.

Non-prescription acne products containing benzoyl peroxide or salicylic acid are applied on the skin to help treat acne. Common side effects of benzoyl peroxide and salicylic acid that are included on the labels or package information of marketed Canadian products are localized skin irritation and dryness. Signs of irritation include redness, burning, peeling and mild swelling.

Health Canada has completed a safety review which includes Canadian and foreign cases of serious hypersensitivity reactions, and has concluded that there is evidence supporting a link between the use of over-the-counter topical acne products containing either benzoyl peroxide or salicylic acid and more serious allergic reactions.

September 28, 2015

Product should contain Panax Ginseng (Panax ginseng C.A. Meyer) as per the label but it incorrectly contains both Panax Ginseng (Panax ginseng C.A. Meyer) and American Ginseng (Panax quinquefolius L.) The NPN is 80017352.

September 30, 2015
Health Canada is informing Canadians that the drug label (product monograph) for the multiple sclerosis drug Gilenya (fingolimod) has been updated with new safety information on the risk of skin cancer, as well as a rare brain infection known as progressive multifocal leukoencephalopathy (PML). Gilenya labelling already contained information on the possible risk of lymphoma, and warnings about how this drug reduces the body's ability to fight infection. It has been updated to include the risk of skin cancer and PML specifically, and to advise that patients and health professionals be vigilant for symptoms.

October 5, 2015

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. What you should do: Contact the Health Products and Food Branch Inspectorate at 1-800-267-9675 if you find a product listed above in the Canadian marketplace. Consult with a healthcare professional if you have health concerns related to the use of any of these products. Read the label of the products you buy to verify that they have been assessed by Health Canada for safety, effectiveness and quality. Health products that have been authorized for sale by Health Canada will have an eight-digit Drug Identification Number (DIN), Natural Product Number (NPN) or a Homeopathic Drug Number (DIN-HM).