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SAFETY BULLETINS

April 23, 2015

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.

April 21, 2015

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.

April 17, 2015

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).

February 28, 2015

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.

February 27, 2015

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.

February 20, 2015

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.

January 5, 2015

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.

December 23, 2014

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.

December 19, 2014

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.

November 28th, 2014

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.

November 26th, 2014

Health Canada advises Canadian parents and caregivers of the potential health risks associated with homemade infant formulas. Health Canada strongly supports breastfeeding and promotes it as the normal and most beneficial method of feeding infants for normal growth, health and development. For babies that are not breastfed or receiving breastmilk, Health Canada recommends only commercial infant formula as a substitute. Health Canada, the Canadian Paediatric Society, and the Dietitians of Canada do not endorse the use of any homemade infant formulas. Homemade infant formulas may not provide the proper balance of nutrients that infants need. Health Canada recommends that Canadians consult their health care professional if they have questions about breastfeeding or if they are considering using infant formulas as a breastmilk substitute. Homemade infant formulas can cause severe malnutrition and potentially fatal illness in infants.

All commercial infant formulas must undergo a full safety and nutritional quality assessment by Health Canada before they can be sold. Formula companies must provide scientific evidence that their products support healthy growth in infants and do not pose chemical or microbiological risks. Formula companies are also required to meet standards for the nutritional content of infant formulas, which include energy, protein, fats, vitamins and mineral nutrients. All manufacturers, importers and distributers of infant formula are responsible for ensuring that their products comply with Canadian legislation.

November 25th, 2014

Health Canada has been notified of an incident in the Province of Quebec resulting in an injury to a consumer from a fire associated with the use of an electronic cigarette in the presence of an oxygen source. According to the information currently available, the injured individual was undergoing oxygen therapy at the time of the incident. Health Canada is aware of similar incidents reported in other countries. Health Canada is working with the relevant authorities to further evaluate the incident in the Province of Quebec. Health Canada is warning consumers of potential risks of using electronic cigarettes while undergoing oxygen therapy. Electronic cigarettes include heating elements and a power source that may be charged from a USB port or a separate battery charger. These sources of heat may ignite the electronic cigarette if they are close to oxygen in a pressurized container, such as the ones that are used for oxygen therapy. Health Canada also warns that electronic cigarette batteries should not be charged near an oxygen source due to the risk of fire. Additionally, Health Canada warns consumers that other kinds of electrical devices may have the potential to cause a fire when used near an oxygen source.

Consumers should not use or charge electronic cigarettes near oxygen sources, such as pressurized containers used for oxygen therapy. Consumers should also refrain from using or charging electrical devices in proximity to oxygen sources, such as pressurized containers used for oxygen therapy. Consumers who are on oxygen therapy should always read and follow the warning labels on the container for the oxygen source.

October 6, 2014

Novartis Pharma Canada Inc. (“Novartis Canada”) and Pfizer Canada Inc. (“Pfizer Canada”), in collaboration with Health Canada, would like to inform you about safety and dosing information for diclofenac-containing tablets or suppositories, which include VOLTAREN/VOLTAREN SR (diclofenac sodium), VOLTAREN RAPIDE (diclofenac potassium), ARTHROTEC (diclofenac sodium/misoprostol) and other diclofenac containing tablets or suppositories. Diclofenac is a medicine used for relieving pain and inflammation.

This safety update does not refer to topical formulations of diclofenac, such as gel or eye drops. Patients should be aware of the following safety labelling information: Diclofenac tablets and suppositories, particularly at high dose (150 milligrams (mg) per day) are associated with an increased risk of a heart attack or stroke.Treatment with diclofenac tablets and suppositories is not recommended in patients with a history of, or risk factors for heart disease, stroke or uncontrolled high blood pressure. The recommended maximum daily dose is now 100 milligrams (mg) per day. Please contact your health care professional if your current dose of diclofenac tablets and suppositories is more than 100 mg per day. As recommended in the Product Monograph, it is important to take the lowest dose of diclofenac that relieves your pain and/or swelling and for the shortest time possible in order to keep your risk of side effects on the heart and blood vessels as small as possible.

September 30, 2014

The following sites were affected: Apotex Pharmachem India Pvt Ltd (APIPL), Apotex Research Private Limited (ARPL), and IPCA Laboratories. The action applies to finished products from ARPL, as well as active pharmaceutical ingredients (APIs) and products made with APIs from APIPL and IPCA. Health Canada has compiled an initial list of products affected by the import ban. The list will be updated as new information becomes available. Certain medically necessary products may be excluded from the action on the condition they are tested by an independent third party before being released for use or sale. Independent testing against specifications will provide confidence that these products meet Canadian quality standards, and will allow consumers to have continued access to medically necessary and safe products.

When data integrity issues were first identified at each of these sites by the U.S. Food and Drug Administration (FDA), Health Canada took action to protect the health and safety of Canadians. There is currently a voluntary quarantine on products from ARPL and IPCA. Products from APIPL have been undergoing additional testing, as required by Health Canada before being allowed on the Canadian market.

September 29, 2014

Baxter Corporation is issuing an Urgent Product Recall for one lot of Calcium Additive due to missing labels on the individual product bottles. The recall applies to Calcium-45 0.5-4.5.