Health Canada warns that products sold by Kerela Ayurvedic & Natural Herbal Consultation in Toronto, ON, may pose serious health risks

UPDATE (February 1, 2022):

Further to its November 25, 2021 advisory, Health Canada is advising consumers that testing of products seized from Kerela Ayurvedic & Natural Herbal Consultation in Toronto, ON, has identified unacceptable levels of heavy metals and prescription drugs. Health Canada continues to advise consumers to stop using all products sold by this clinic.

Health products seized by Health Canada from this clinic are not authorized for sale. Selling unauthorized health products is illegal in Canada. Unauthorized health products have not been assessed by Health Canada for safety, effectiveness and quality.

Health Canada previously warned about mercury and lead found in products that a clinic patient had been taking. Health Canada testing of products seized from the clinic found high levels of arsenic, mercury or lead in 14 of the 15 samples tested. Three products were also found to contain prescription drugs: one contained diclofenac and dexamethasone, another contained progesterone and norgestrel, and the third contained cetirizine.

Arsenic, lead and mercury are heavy metals. They may pose serious health risks when consumed in excessive amounts, as they can accumulate in vital organs of the body. Children, pregnant women and breastfeeding women are most susceptible to the toxic effects.

When consumed in excessive amounts, arsenic can cause skin and lung cancers, heart and lung diseases, and brain damage. Lead can cause abdominal pain, anemia, changes in blood pressure, reproductive disorders such as miscarriage, weakness, concentration problems, weight loss, insomnia, dizziness, and kidney and brain damage. Mercury can cause irritability, tremors, memory loss, insomnia, concentration problems, and kidney and brain damage.

Prescription drugs should only be taken under the advice and supervision of a health care professional because of the risk of interactions with other medications and side effects. Prescription drugs can only be legally sold with a prescription.

Cetirizine is a non-prescription antihistamine at strengths of 5 or 10 mg, and a prescription drug at 20 mg. It is used to relieve allergy symptoms. The most common side effects associated with its use include headache, drowsiness and dry mouth. Very rare but serious side effects can include severe allergic reactions in persons hypersensitive to this drug.

Dexamethasone is a steroidal prescription drug used to treat inflammatory conditions such as arthritis and allergic reactions. Side effects include irregular heartbeat, increased blood pressure, stomach ulcer, blood disorders, skin, muscle and bone damage, and nervous system disorders. Sudden discontinuation may cause symptoms of withdrawal. It should not be used by patients who have certain types of infections (such as varicella or genital herpes), who are receiving live virus vaccines (such as vaccines for chickenpox or measles, mumps and rubella), or who are allergic to dexamethasone.

Diclofenac is a non-steroidal anti-inflammatory drug (NSAID) used to relieve pain and inflammation (for example, pain and swelling associated with certain types of arthritis). In oral format (taken by mouth), it is a prescription drug. Diclofenac increases the risk of serious heart-related events (such as heart attack and stroke), high blood pressure, stomach or intestinal bleeding or ulcers, severe kidney or liver problems, and bleeding or clotting problems. It should not be used by patients who have: severe heart problems; stomach or intestinal conditions; bleeding disorders; a history of asthma or allergic-type reactions after taking diclofenac, acetylsalicylic acid (ASA) or other NSAIDs; severe kidney or liver problems; or high potassium. It should also not be used by children less than 16 years old, or by women in the third trimester of pregnancy or who are breastfeeding. Use in the first and second trimester of pregnancy must be carefully weighed by a doctor and may require increased monitoring. Diclofenac risks may be higher for patients taking other medications, as well as elderly patients.

Progesterone is a hormone that occurs naturally in the body. The synthetic form, progestin, is a prescription drug. Side effects of progestin include headache, depression, insomnia, breast lumps or discomfort, and irregular vaginal bleeding. When combined with estrogen (as birth control pills or hormone replacement therapies), progestin is associated with serious side effects, including an increased risk of blood clots in various parts of the body (e.g., lungs, legs and brain). Progestin-containing products should not be used in patients who: have a history of or actual thromboembolic (blood clot), cardiovascular or cerebrovascular disorders; active liver diseases or tumours; breast cancer or other estrogen-dependent growth (benign or cancerous); undiagnosed abnormal vaginal bleeding; or who are or who may be pregnant. Norgestrel belongs to the class of progestin drugs. It is often used in combination with estrogen in birth control pills. Overall, the risks associated with norgestrel are similar to that of progesterone/progestin.

Should any new health risks be identified, the Department will communicate with Canadians as needed.

Original Advisory (November 25, 2021): Health Canada warns that products sold by Kerela Ayurvedic & Natural Herbal Consultation in Toronto, ON, may pose serious health risks

Health Canada is warning consumers that Ayurvedic medicinal products sold by Kerela Ayurvedic & Natural Herbal Consultation located in Toronto, ON (2900 Markham Rd, Unit L13 in Majestic City Mall) are unauthorized and may pose serious health risks. This includes products purchased at the clinic, or ordered by the clinic from its supplier and shipped directly to customers.

Health Canada seized products from the clinic after Public Health Ontario notified the Department of a case of lead poisoning following the use of products obtained from the clinic. Laboratory testing, facilitated by Public Health Ontario, identified high levels of lead and mercury in products the patient had been taking.

Lead and mercury are heavy metals that may pose serious health risks when consumed in excessive amounts, as they can accumulate in vital organs of the body. Children, pregnant women and breastfeeding women are most susceptible to the toxic effects. Lead effects include abdominal pain, anemia, changes in blood pressure, reproductive disorders such as miscarriage, weakness, concentration problems, weight loss, insomnia, dizziness, and kidney and brain damage. Mercury effects include irritability, tremors, memory loss, insomnia, concentration problems, and kidney and brain damage.

Ayurvedic medicinal products are used in traditional South Asian healing practice and are often imported. Improper manufacturing processes may result in dangerously high levels of heavy metals in the final products. Health Canada reminds consumers who choose to use Ayurvedic medicinal products to only select those authorised for sale in Canada. These products will have a Natural Product Number (NPN) on the label.

The products seized by Health Canada were packaged in clear plastic containers with handwritten labels and may have been distributed to patients in resealable plastic bags. These products are not authorized for sale by Health Canada, which means they have not been evaluated for safety, effectiveness and quality. Selling unauthorized health products is illegal in Canada.

Kerela Ayurvedic & Natural Herbal Consultation was also found to be operating without a Health Canada site license. A site licence is required for a company to manufacture, package, label or import natural health products (including Ayurvedic medicinal products) for sale in Canada. A site licence reflects that a company has demonstrated that they follow Good Manufacturing Practices (GMPs), a standard that helps to ensure the quality of health products sold to Canadians.

At Health Canada's direction, the clinic stopped importing and selling unauthorized Ayurvedic products, including products shipped directly to consumers from foreign suppliers. Health Canada is testing seized products and is continuing to work with Public Health Ontario and Toronto Public Health. The Department will inform Canadians as needed, should any new health risks be identified.