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".
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.
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.
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).
Health Canada is working with the Canadian manufacturers of prescription oral ibuprofen products to update the safety information regarding the risk of serious cardiovascular side effects (e.g., heart attack and stroke) when these products are used at high doses (at 2400 mg/day). This risk increases with dose and duration of use. Ibuprofen is a non-steroidal anti-inflammatory drug (NSAID) used for pain and fever relief, and to reduce inflammation. The majority of ibuprofen products in Canada are available over-the-counter. These products have a maximum recommended dose of 1200 mg per day and are to be used for a short duration of time (seven days or less). No evidence of an increased cardiovascular risk has been found with over-the-counter ibuprofen when used as directed. Serious heart- and stroke-related events are a known risk with all NSAIDs and the prescribing information contains extensive warnings on this risk. Health Canada's review concluded that the benefits of prescription oral ibuprofen products continue to outweigh the risks as an effective pain and inflammation treatment, but that additional measures are needed for these products to further reduce the cardiovascular risk.
The manufacturers of methylphenidate products, in consultation with Health Canada, would like to inform healthcare professionals, parents/caregivers and patients that reports of priapism have been received from the worldwide and Canadian experience. Drugs can be a cause of priapism. Priapism has been reported very rarely in patients treated with methylphenidate products even though they are frequently prescribed. From January 1, 1965 to December 31, 2014, 2 cases of suspected priapism in association with methylphenidate products were reported in Canada. Priapism is considered a medical emergency. For this reason, it is important that patients, parents/caregivers and healthcare professionals be aware of this rare risk of priapism and seek immediate medical attention for priapism to prevent potential long-term effects on the penis.
Health Canada has suspended the licence of Filix Mas, a homeopathic product, because it contains the ingredient male fern (Dryopteris filix-mas). Safety information has raised potential concerns regarding effects of the specific ingredient at higher doses, and as such consumers should stop using the affected product immediately as it may pose a serious health risk. On April 2, 2015, Health Canada suspended the licences of two natural health products containing male fern. The product affect is Filix Mas (DIN-HM 80018123).
Shah Brothers Imports is recalling Shabros brand Kalonji Whole from the marketplace due to possible Salmonella contamination. Consumers should not consume the recalled product. Check to see if you have recalled products in your home. Recalled products should be thrown out or returned to the store where they were purchased. Food contaminated with Salmonella may not look or smell spoiled but can still make you sick. Young children, pregnant women, the elderly and people with weakened immune systems may contract serious and sometimes deadly infections. Healthy people may experience short-term symptoms such as fever, headache, vomiting, nausea, abdominal cramps and diarrhea. Long-term complications may include severe arthritis.
Health Canada was made aware of the death of an infant and the serious injury of other family members from exposure to what appears to be a phosphine pesticide. A second child has since died as a result of this incident. This pesticide, which is highly toxic to humans and animals, was imported for personal use from abroad and was being used in the residence for the control of bedbugs. In Canada, phosphine pesticides can only be sold to individuals holding an appropriate pesticide applicator certificate or licence and are not approved for use on bedbugs. Health effects from exposure to phosphine can include severe injury or death. Health Canada is also aware of other incidents involving the use of ozone generators (machines that produce ozone gas) for the control of bedbugs. Ozone generating devices are not safe to use and can cause respiratory problems including coughing, chest pain, shortness of breath, and irritation of eyes, nose and throat. Health Canada is warning Canadians of the extreme danger of using unregistered pest control products, including those imported from other countries or obtained when travelling abroad. The department reminds Canadians that pesticides should only be used according to the directions outlined on product labels.
Eleven lots of olanzapine distributed by Pharmascience Inc., Pro Doc Limitée and Laboratoire Riva Inc. are being voluntarily recalled. There is a possibility that bottles from the recalled lots may contain tablets of a different drug, ondansetron. Inadvertent ingestion of ondansetron may lead to adverse effects or drug interactions. Missing a dose of olanzapine may lead to reduced control of symptoms. Bottles of the affected lots should not be used and should be returned as outlined in the Recall Notice issued by Pharmascience Inc., Pro Doc Limitée and Laboratoire Riva Inc. Please review Health Canada's Advisory website to see a full list of lot numbers.
Sandoz Canada Inc., Apotex Inc., Omega Laboratories Limited and Pendopharm Division of Pharmascience Inc. in consultation with Health Canada, would like to inform you of important new safety information concerning the potential risk of abnormal involuntary movements of the body called extrapyramidal symptoms that have been reported in children treated with metoclopramide at a recommended dose. In Canada, metoclopramide is approved for the treatment of delayed stomach emptying and for medical procedures such as inserting a tube into the small bowel (called small bowel intubation). Abnormal involuntary movements called extrapyramidal symptoms may occur in children receiving the recommended dose of metoclopramide. Do not use metoclopramide in children less than one year of age as they appear to be at higher risk of extrapyramidal symptoms. Do not use metoclopramide in children greater than one year of age without talking to your doctor.
The unauthorized product “Hydro-Lean” was seized from two Calgary stores because the label indicates it contains a combination of ingredients that can cause serious health risks (ephedrine and caffeine). Canadians suffering from heart conditions, high blood pressure and diabetes are particularly at risk. Hydro-Lean is promoted for body building purposes, including for weight loss and increased energy. It has not been approved for sale in Canada.
The sexual enhancement product "Herberex" (NPN 80041180) is being recalled nationwide after Health Canada testing confirmed it contains an undeclared drug: tadalafil. The distributor, Empire Health Distribution of Terrebonne, Quebec, is recalling all lots of this product from retail stores across Canada. Promoted as a natural sex enhancer for men and women, this product may pose serious health risks, especially for people with heart problems.
A vendor in Atlantic Canada (Health Recovery Information) is selling Miracle Mineral Solution (MMS), an unauthorized drug product which Health Canada has previously warned may pose serious risks to health if ingested. This product, which is a chemical used mainly as a textile bleaching agent and disinfectant, is being promoted as a cure for cancer, HIV, flu and malaria by the company. Canadians who have purchased Miracle Mineral Solution or Master Mineral Solution products on the Internet from the website Health Recovery Information. Stop using Miracle Mineral Solution products immediately.
Consult your doctor or pharmacist if you have used or are using Miracle Mineral Solution products distributed by Health Recovery Information or any other distributor. The products affected are MMS Package containing two bottles: one labelled to contain 28% Sodium Chlorite and Distilled Water and the other labelled to contain 50% Citric Acid.
