UPDATE - Advisory - Dozens of health products seized from Aphrodite Aesthetic Clinic in North York, Ontario, may pose serious health risks

Update – August 26, 2019 – Health Canada conducted a second visit to this clinic and seized dozens of additional unauthorized health products, including prescription and non-prescription drugs, natural health products and medical devices (such as dermal fillers). Many of the products may have been for administration at the clinic for cosmetic purposes. One of the seized products, an unauthorized prescription antibiotic (Amoxicillin Capsules), may have been sold to consumers for home use. The information below has been updated to include this product. 

OTTAWA, Aug. 26, 2019 /CNW/ - Health Canada is advising Canadians that it has seized health products from Aphrodite Aesthetic Clinic (3311 Bayview Avenue, Unit 101, North York, Ontario) because they may pose serious health risks.

Health Canada seized dozens of products not authorized for sale in Canada, including:

• Prescription drugs in various formats (oral, topical and injectable), including a weight-loss drug, an antibiotic ointment, antifungal vaginal tablets and various injectable drugs for cosmetic purposes. The labels for these products indicate that they contain ingredients that require a prescription to be sold in Canada.
• Products labelled as human placenta solutions and stem cell solutions.
• Natural health products, such as topical skin solutions.
• Medical devices, such as injectable dermal fillers.
• Unlabelled pre-filled syringes that could not be identified.

Health Canada also seized authorized prescription drugs and medical devices. Prescription drugs can be sold only by a licensed health care professional. The seized medical devices were labelled for use by trained health care professionals only. Health Canada was not able to confirm that a licensed or trained health care professional, such as a physician, was working at the clinic, despite online advertising indicating that the clinic offers multiple plastic surgery services.

Who is affected
Consumers who have bought or used any of the affected products listed below, or who have received treatment at the Aphrodite Aesthetic Clinic.

Affected products
Health Canada seized various types of products that may have been administered at this clinic as well as the following unauthorized products that consumers may have purchased for use at home:

What consumers should do

• Do not use the products listed above. Consult with a licensed health care professional if you have used any of these products or if you have received treatment from Aphrodite Aesthetic Clinic and have health concerns.
• Consult with your health care provider when considering a cosmetic procedure, such as the use of injectable fillers. You should be aware of the potential risks and benefits of the procedure before getting treatment.
• Verify that people representing themselves as medical doctors or surgeons are licensed by checking their status with the College of Physicians and Surgeons in your province or territory.
• Report concerns regarding the illegal practice of medicine to the College of Physicians and Surgeons in your province or territory.
• Read product labels to verify that health products have been authorized for sale by Health Canada. Authorized health products have an eight-digit Drug Identification Number (DIN), Natural Product Number (NPN) or Homeopathic Drug Number (DIN-HM). You can also check whether products are currently authorized for sale by searching Health Canada's Drug Product Database and Licensed Natural Health Products Database.
• Verify whether a medical device is licensed by searching the online Medical Devices Active Licence Listing database (use the product name or company shown on the packaging), or by calling Health Canada at 1-800-267-9675.
• Report any health product adverse events or complaints to Health Canada.

What Health Canada is doing
Following receipt of an anonymous complaint, Health Canada inspected Aphrodite Aesthetic Clinic and seized numerous health products.

As the practice of medicine is regulated by the provinces and territories, Health Canada is in contact with the College of Physicians and Surgeons of Ontario regarding this matter and has also informed Toronto Public Health.

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

Selling unauthorized health products in Canada is illegal. Health products that have not been authorized by Health Canada have not been assessed for safety, effectiveness and quality, and may pose serious health risks. For example, unauthorized drugs may:

• be fake;
• be contaminated;
• contain dangerous ingredients not listed on the label; or
• not contain the drug shown on the label.

Potential risks associated with the use of unauthorized stem cell therapies and human placenta products include bacterial and viral disease transmission. The risk is higher when the product is not obtained from the patient's own body. 

Unauthorized medical devices may be low quality, may not work, or may not be safe.

In addition, unauthorized injectable health products carry significant risk because of the potential for infection, including scarring and poor outcomes.

Several of the drugs listed in the table above are not labelled in English and French as required in Canada. As a result, information about ingredients, usage, dosage and side effects may not be available to or understood by all consumers.

Amoxicillin is a prescription antibiotic drug used to treat certain infections caused by bacteria. It should not be used by people who are allergic to it. Serious side effects include severe allergic reactions (swollen nose, eyes, throat, difficulty breathing and skin rash), nausea, vomiting, diarrhea, and signs of kidney and liver problems. Unnecessary use or misuse of any antibiotic can lead to a decrease in its effectiveness.

Gentamicin is a prescription antibiotic drug applied topically (to the skin) to treat minor skin infections. It can cause skin redness and irritation. Prolonged use can cause fungal or bacterial infections. Gentamicin may be absorbed into the blood if applied to large areas of skin, especially if the areas are cracked or raw, which increases the risk of serious side effects. Serious side effects include allergic reactions (e.g., rash, hives, and red, swollen, blistered, or peeling skin with or without fever, trouble breathing, swelling of the mouth, face, lips, tongue or throat) and kidney and hearing damage. It should not be used in patients who are allergic to gentamicin. Gentamicin may interact with other drugs and should be used with caution with other antibiotics, anti-cancer drugs, diuretics, immunosuppressants, and nonsteroidal anti-inflammatories.

Orlistat is a prescription weight-loss drug. Side effects include abdominal pain, liquid and oily stools, and increased stool volume and frequency. It can cause allergic reactions (e.g., rash, hives, or difficulty breathing), serious skin rashes, thyroid changes, pancreatitis, severe liver injury, gallstones, kidney stones and kidney damage. It should not be used by patients with chronic malabsorption, gallbladder problems or by those who are allergic to orlistat. It should be used with caution in patients taking cyclosporine, diabetic or thyroid medication, and those with bowel disease or kidney damage. Because it affects absorption from the gut, it can decrease the effect of anticoagulants, birth control pills (possibly leading to unintended pregnancy) and medicines to control seizures.

Clotrimazole is a prescription drug used to treat vaginal yeast infections. It can cause nausea, abdominal pain, rashes (e.g., swelling or redness) and allergic reactions (e.g., low blood pressure or hives). It should not be used by patients who are allergic to clotrimazole. It can interact with tacrolimus and sirolimus drugs.

Nitroglycerin is a prescription drug used to treat acute attacks of angina (chest pain from heart disease). It may cause headaches, low blood pressure, nausea, vomiting, weakness, dizziness, shortness of breath and rapid heart beat. It is contraindicated (should not be used) and could be dangerous in patients with known hypersensitivity to nitroglycerin, closed angle glaucoma, heart failure due to damaged heart valves, low blood pressure, increased pressure in the brain, or in patients who are breast feeding or pregnant. It is absolutely contraindicated in patients taking drugs for impotence (sildenafil, tadalafil or vardenafil) as it could lead to severe low blood pressure, heart attack and death. Nitroglycerin should be used with caution with other products that lower blood pressure, including anti-hypertensives, diuretics, antidepressants (imipramine, amitriptyline, desipramine or nortriptyline), calcium channel blockers, alcohol, and drugs that treat schizophrenia, pulmonary hypertension or migraine (dihydroergotamine).

Stay connected with Health Canada and receive the latest advisories and product recalls.

Également disponible en français

SOURCE Health Canada