Public advisory - Unauthorized UMARY Hyaluronic Acid Dietary Supplement contains undeclared prescription drugs and may pose serious health risks

OTTAWA, ON, Aug. 27, 2024 /CNW/ -

Summary

Umary front (CNW Group/Health Canada (HC))

Umary USA (CNW Group/Health Canada (HC))

• Product: Unauthorized UMARY Hyaluronic Acid Dietary Supplement
• Issue: Health products – Undeclared substance
• What to do: Do not use this product. Consult a health care professional if you have used this product and have health concerns. Read product labels to verify that health products have been authorized for sale by Health Canada. Return products to your local pharmacy for proper disposal.

Images

Affected products
UMARY Hyaluronic Acid Dietary Supplement

Issue

UPDATE: August 27, 2024:
Testing of another version of the unauthorized UMARY-brand product, this one labelled as "UMARY USA Hyaluronic Acid," found the presence of the prescription drug dexamethasone in addition to those previously identified (diclofenac and omeprazole). None of these drugs were listed on the product label and they may pose serious health risks as consumers would be unaware they are taking them. There are no UMARY-brand products currently authorized for sale in Canada.

Original Advisory – May 14, 2024: 
Health Canada tested UMARY brand Hyaluronic Acid and found the presence of prescription drugs diclofenac and omeprazole, which were not listed on the label. The Department is warning consumers not to use this product because these ingredients may pose serious health risks. This product, which is labelled in Spanish and does not have a Natural Product Number (NPN) on the label, is not authorized for sale in Canada, but is being promoted and sold to consumers in Canada on various online platforms.

Health Canada will continue to work with the identified online platforms to stop the advertising and sale of this unauthorized product.

Selling unauthorized health products in Canada is illegal. Unauthorized health products have not been approved by Health Canada, which means that they have not been assessed for safety, efficacy and quality and may pose a range of serious health risks. For example, they could contain high-risk ingredients, such as prescription drugs, additives or contaminants that may or may not be listed on the label. These ingredients could interact with other medications and foods. In addition, these products may not actually contain the active ingredients that consumers would expect them to contain to help maintain and improve their health.

Prescription drugs should only be used under the advice and supervision of a health care professional because they are used to treat specific conditions and may cause serious side effects. Prescription drugs can only be legally sold to consumers in Canada with a prescription.

What you should do

• Do not use this product. Consult a health care professional if you have used this product and have health concerns. Return the products to your local pharmacy for proper disposal.
• 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 have been authorized for sale by searching Health Canada's Drug Product Database and Licensed Natural Health Product Database.
• Report any health product-related side effects or complaints to Health Canada.
• Avoid buying health products from questionable or untrustworthy websites. Be aware of the risks of buying health products online.

Background

Dexamethasone is a steroidal prescription drug used to treat inflammatory conditions such as arthritis and allergic reactions. Side effects may 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 for oral consumption is a prescription non-steroidal anti-inflammatory drug (NSAID) used to relieve pain and swelling caused by arthritis. It should be used only under the supervision of a health care professional. It 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 acetylsalicylic acid (ASA) or NSAIDs including diclofenac; severe kidney or liver problems; or high potassium in the blood. It should also not be used by children less than 16 years of age, or by patients in the third trimester of pregnancy or who are breastfeeding. Use in the first and second trimester of pregnancy must be carefully considered by a doctor, and patients may require increased monitoring. Diclofenac risks may be higher for patients taking other medications, as well as elderly patients.

Omeprazole is a prescription drug known as a proton-pump inhibitor (PPI) used to reduce acidity in the stomach to help manage some medical conditions, such as stomach ulcers. It should be used only under the supervision of a health care professional. It should not be used by patients with allergies to omeprazole or similar drugs, or by patients who are taking rilpivirine. Its use in patients under 18 years of age requires consultation with a health care professional. Omeprazole passes into breast milk and should not be used by patients who are pregnant or breastfeeding, unless its use is considered essential by a doctor. Omeprazole interferes with the absorption of vitamin B12 from food and may cause a deficiency. Omeprazole may lead to low blood magnesium, low blood calcium and low blood potassium. Rare but serious side effects of omeprazole include kidney and liver problems, fungal infections of the digestive tract, increased skin sensitivity to sunlight, severe skin reactions, and blood disorders. Using omeprazole for a long time may increase the risk of bone fractures and may cause bacterial overgrowth in the stomach. Omeprazole might interact with other medications and cause serious adverse reactions. Omeprazole risks may be higher in elderly patients.

                                                                Également disponible en français

SOURCE Health Canada (HC)

Media Enquiries: Health Canada, [phone], [email protected]; Public Enquiries: [phone], 1-866 225-0709, [email protected]