October 25, 2019

Health Canada is advising Canadians that soft-shelled hyperbaric chambers that are promoted online or offered as a service to treat a variety of medical conditions—including autism, cerebral palsy and migraines—are unauthorized medical devices and may pose serious health risks, including death.

Oxygen therapy using hard-shelled hyperbaric chambers is a well-established medical treatment where patients are placed in an oxygen-rich and pressurized environment. While Health Canada has licensed five hard-shelled hyperbaric chambers for sale in Canada, it has not licensed any soft-shelled devices, meaning they have not been evaluated for safety, quality and effectiveness.

To date, Health Canada has not received any evidence supporting the benefits of the soft-shelled version of these devices, and manufacturers have not demonstrated that the soft-shelled models are effective for treating any medical conditions.

November 4, 2019

Results from a post-market clinical study (the CARES trial)1 found an increased risk of cardiovascular (CV) fatal outcomes in patients with gout and known cardiovascular disease treated with ULORIC, when compared to those treated with allopurinol (see Background section for more details). Healthcare professionals are advised to: Use ULORIC only in adult patients with gout who have an inadequate response or intolerance to allopurinol, or for whom treatment with allopurinol is inappropriate (second line therapy). Not recommend ULORIC treatment in patients with ischemic heart disease or congestive heart failure.

Monitor for signs and symptoms of myocardial infarction, stroke and cardiac failure in patients who are taking ULORIC. The Canadian Product Monograph (CPM) for ULORIC has been updated to include a revised indication for use and safety information, including a new Serious Warnings and Precautions Box with regards to increased risk of cardiovascular death.

Health Canada is advising Canadians that Pharm Canada Inc. is recalling all lots of “Passion X” and “Passion Fem” from retail because they contain an undeclared prescription drug ingredient (sildenafil) and may pose serious health risks. The products are marketed to help support emotional aspects of sexual health.

In addition, Health Canada suspended all of the company’s sexual health product licences, which means no person or company is permitted to sell these products in Canada (see affected products below). Pharm Canada Inc. confirmed “Passion X” and “Passion Fem” are the only sexual health products it was marketing in Canada.

Prescription drugs should be taken only under the advice and supervision of a health care professional because they are used to treat specific diseases and may cause serious side effects.

Health Canada is recalling the following items because the assay is out of specification in the affected lots.

Alternate Brand Names:
Centrum Multigummies + Antioxidant;
Centrum Multigummies Antioxidant;
Centrum Multigummies Multi Plus Antioxidant

Additional ranitidine drugs are being recalled by four companies: Apotex Inc., Pro Doc Limitée, Sanis Health Inc., and Sivem Pharmaceuticals ULC. The lots are being recalled as they may have been manufactured using an active pharmaceutical ingredient containing an impurity, N-nitrosodimethylamine (NDMA), above acceptable levels. Please refer to the Affected Products table on Health Canada's website for detailed information on the recalled lots.

Health Canada is advising Canadians that infrared saunas are not authorized in Canada to treat any medical conditions, including high blood pressure, diabetes or autism. Infrared saunas are also not authorized in Canada for weight loss, pain relief, cancer prevention or anti-aging.

Health Canada is not aware of any clinical evidence that proves infrared saunas can be used to treat any medical condition. Health Canada is aware that certain spas and vendors are promoting infrared saunas with health claims. As a result, Canadians may be putting their health at risk by using infrared saunas to treat their medical conditions rather than getting help from a healthcare practitioner.

To protect the health and safety of Canadians, Health Canada is informing companies selling infrared saunas (manufacturers, distributors, vendors, importers) that it is illegal to advertise, import for sale, or sell these devices with health claims in Canada unless they are licensed for sale by Health Canada. Health Canada is also requesting that all promotion and sale of unlicensed infrared saunas for medical uses stop immediately. Health Canada could take compliance and enforcement actions if companies continue to promote or sell unlicensed infrared saunas in Canada.

Health Canada recognizes that Canadians may choose to consume alcohol, cannabis, or other drugs while attending events, festivals and other gatherings in the summer months. While the safest option is to not consume these substances, being aware of the risks can help reduce the potential harms.

• Do not drive after having consumed alcohol, cannabis or other drugs. Decide who will be the designated driver before you consume any of these substances, or take a taxi, public transportation or walk.
• Do not get into a car if you suspect the driver has consumed alcohol, cannabis or other drugs, and ensure the driver does not continue driving.
• Avoid mixing substances such as alcohol, cannabis and other drugs. The results can be unpredictable and dangerous.
• Illegal drugs often contain other dangerous substances, such as highly toxic opioids like fentanyl and carfentanil, which can lead to overdose and death.
• Do not leave someone alone if they seem ill. Stay with them and immediately call for help.
• To buy, possess or use cannabis and alcohol, you must be of legal age (18 or 19 or older, depending on your province or territory). It is illegal to buy, possess or use other drugs that have not been prescribed to you.

Health Canada has completed a safety review of human health products and veterinary drugs containing gentian violet and has found that exposure to these products may increase the risk of cancer. Given the seriousness of this risk, Health Canada is advising Canadians to stop using all human and veterinary drug products containing gentian violet.

Gentian violet is an antiseptic dye used to treat fungal infections. Products containing gentian violet have been used on the skin, on mucous membranes (inside the nose, mouth or vagina), on open wounds, or on the nipple of a nursing mother to treat oral thrush in infants.

Health Canada’s risk assessment of medical devices containing gentian violet found that the gentian violet is unlikely to come into direct contact with the skin. Therefore, these products do not pose an increased risk of cancer when used for a short time and in most people, and they remain on the market in Canada. However, you should not use dressings containing gentian violet for longer than six months, or if you are pregnant or nursing.

Health Canada is conducting a safety review after issues were discovered during a clinical trial involving rheumatoid arthritis patients being treated with the drug tofacitinib (sold in Canada under the brand names Xeljanz and Xeljanz XR).

Tofacitinib is a prescription drug used to treat adults with moderate to severely active rheumatoid arthritis, active psoriatic arthritis, or moderate to severely active ulcerative colitis in people who do not respond well to other medications. It is generally prescribed in combination with other drugs, such as methotrexate.

The ongoing clinical trial, run by Pfizer, found an increased risk of blood clots in the lungs and of death when the drug was taken at a high dose of 10 mg, twice a day. Patients who were taking 10 mg of tofacitinib twice a day are now transitioning to the lower, currently authorized dose of 5 mg twice a day.

Health Canada is reminding Canadians that plasma pens are not authorized for sale in Canada and that these devices may pose health risks. Health Canada is also underlining that consumers should be wary of spas promoting plasma pen services. Health Canada continues to receive complaints of plasma pen sales and spa services. Health Canada is also aware that some beauty academies are selling the unauthorized devices to esthetician trainees once they have completed their training.

Plasma pens are small handheld medical devices that generate electrical discharges on the surface of the skin, which causes a controlled burn and spreads heat throughout the targeted area. They are promoted for cosmetic skin treatments such as eyelid lifts, wrinkle reduction and the removal of moles, skin tags, scars and spots. Health Canada has not authorized any plasma pens for sale in Canada, which means that they have not been evaluated for safety, effectiveness or quality. It is illegal to advertise for sale, import for sale, or sell medical devices in Canada without appropriate licensing under the Medical Devices Regulations.

Healthcare professionals including rheumatologists, dermatologists, immunologists, internists, cardiologists, nephrologists, pulmonologists, neurologists, family physicians, nurses at clinics contracted to administer BENLYSTA, psychiatrists, psychologists, and pharmacists. In a recent post-marketing study (BEL115467), depression, suicidal ideation or behaviour, and self-injury were reported more frequently in patients receiving BENLYSTA plus standard therapy, when compared to patients taking placebo plus standard therapy

Healthcare professionals are advised to: Evaluate the risk of depression, suicidal ideation or behaviour, and self-injury before starting and during treatment with BENLYSTA. Advise patients and their caregivers to contact a healthcare provider if patients experience new or worsening depression, suicidal ideation or behaviour, or self-injury. Evaluate and refer patients experiencing new or worsening depression, suicidal ideation or behaviour, or self-injury to a mental health professional, as needed.

Health Canada is advising Canadians that multiple lots of Losartan-containing drugs are being voluntarily recalled by Teva Canada, Apotex Inc., Pharmascience Inc., and Pro Doc Limitée because of the potential for a nitrosamine impurity, N-Nitroso-N-methyl-4-aminobutyric acid (NMBA).

NMBA is potentially a human carcinogen, which means that long-term exposure could increase the potential risk of cancer.

Teva Canada is voluntarily recalling two lots of combination Losartan/hydrochlorothiazide (HCTZ) tablets after testing of one lot identified levels of NMBA above what is considered reasonably safe if the drug were taken over a lifetime. Apotex Inc., Pharmascience Inc., and Pro Doc Limitée are voluntarily recalling multiple lots of Losartan-containing products as a precaution.

The Losartan active pharmaceutical ingredient (API) in all of the recalled products is manufactured by Hetero Labs Ltd. Unit 1, in India. These recalls represent all lots of drugs distributed in Canada that contain Losartan API manufactured at Hetero Labs Ltd. Unit 1. There have been multiple recalls of products containing another sartan, valsartan, in Canada and internationally since July 2018 because of nitrosamine impurities (see links below for more information).

Health Canada is concerned about false claims being made in some marketing of homeopathic remedies, known as nosodes, stating that the product can prevent infectious diseases. Nosodes are not, and never have been, approved by Health Canada to be vaccine alternatives. There is no evidence supporting their effectiveness in preventing or treating infectious diseases. No homeopathic products should be promoted as an alternative to vaccines because there are no substitutes for vaccines.

Health Canada is aware of reports that some homeopathic and naturopathic practitioners are promoting nosodes for “homeoprophylaxis,” suggesting they can protect children from illness. The Department has not approved any nosodes with homeoprophylaxis claims. We are following up on these reports, and if we identify any non-compliance with the Food and Drugs Act or its regulations, we will take action.

The Government of Canada is committed to better informing Canadians about the risks of health products that contain opioids. Following a safety review of cough and cold products containing opioids, Health Canada is advising that Canadian children and adolescents (under 18 years of age) should not use cough and cold products containing codeine, hydrocodone and normethadone, as a precautionary measure.

Health Canada's safety review found that there is limited evidence to support the effectiveness of these products in children and adolescents (under 18 years of age). In addition, while the review did not find any strong evidence linking cough and cold products that contain opioids with opioid use disorders in children and adolescents, it did find that the early use of opioids may be a factor in problematic substance use later in life. Given the lack of strong data on effectiveness and the potential for longer-term risks, the Department is taking action to advise Canadians about the risks of these products.

Health Canada is warning Canadians that Ayurvedic products sold by A1 Herbal Ayurvedic Clinic Ltd. may pose serious health risks.

Health Canada inspectors have seized products, ingredients and equipment from A1 Herbal Ayurvedic Clinic Ltd. in Surrey, British Columbia (31-8430, 128 Street), and from an affiliated clinic in Brampton, Ontario (11-351 Parkhurst Square). The seizures came after the British Columbia Centre for Disease Control informed Health Canada of a case of heavy metal toxicity involving a patient who was using products from the Surrey clinic. Laboratory testing identified lead and mercury in the products. Lead and mercury are heavy metals that may pose serious health risks when consumed in excessive amounts. Children, pregnant women and breastfeeding women are most susceptible to the toxic effects of heavy metals.