OTTAWA, Dec. 20, 2017 /CNW/ -
Health Canada is advising Canadians that it has seized several unauthorized drugs that may pose serious risks to health. The products were seized from Before & After Beauty Lab, at 115-4231 Hazelbridge Way, in Richmond, B.C.
The seized products include unauthorized injectable products and products applied on the skin, including a high-concentration lidocaine cream, a drug labelled as human placenta, and a drug labelled as being derived from stem cells. The products are packaged and labelled in languages such as Japanese or Korean. As a result, information about ingredients, usage, dosage and side effects may not be understood by all users.
All drug products sold in Canada must be authorized for sale by Health Canada. Taking drugs that have not been authorized by Health Canada may pose serious health risks as they have not been assessed for safety, effectiveness or quality.
Who is affected
- Consumers who have been administered or used any of these unauthorized products.
- Be balance ALA (aminolevulinic acid) Concentrate
- Dr Maylab "Losheen Stem Cells Therapy" Amniotic Fluid-derived stem cells
- J-Cain lidocaine cream (15.6%)
- Mastelli Placentex (polydeoxyribonucleotide 5.625 mg/3ml injectable solution)
- Melsmon Placenta (Human)
- MSD Gentacin Ointment 0.1% (gentamicin)
What consumers should do
- Do not use these products from Before & After Beauty Lab or from other locations. Consult with your health care professional if you have used or have been administered any of these products and have health concerns.
- 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 adverse events to health products to Health Canada by calling toll-free at 1‑866‑234‑2345, or by reporting online, by mail or by fax.
- Report complaints about health products to Health Canada by calling toll-free at 1‑800‑267‑9675, or complete an online complaint form.
What Health Canada is doing
Health Canada seized the unauthorized products from Before & After Beauty Lab and is working with the Canada Border Services Agency to help prevent further importation of these products. Should additional retailers or distributors be identified, Health Canada will take appropriate action and inform Canadians as necessary.
None of the products listed above have been authorized by Health Canada and may pose serious health risks as they have not been assessed for safety, effectiveness or quality. Authorized prescription drugs should be obtained only from pharmacies that are licensed by the applicable province or territory in which they operate. Consumers who take a prescription drug without being under the care of a health care professional may not receive appropriate treatment. They may also put themselves at risk for harmful drug interactions and dangerous side effects.
ALA (aminolevulinic acid) is a prescription drug applied to the skin by qualified health professionals followed by special blue light therapy to treat actinic keratoses (rough, scaly, potentially pre-cancerous patches of skin). The drug increases photosensitivity (sensitivity to light). ALA together with the blue light results in sunburn-like reactions on the treated and surrounding areas of the skin, including redness, swelling, tingling, itching, scaling, bleeding or blistering. Exposure of treated skin to direct sunlight or bright indoor light may lead to more severe skin reactions. The use of ALA with other photosensitizing medications, including some antibiotics, diuretics and psychiatric medications, may also lead to more severe skin reactions.
Gentamicin is a prescription antibiotic drug. The use of topical gentamicin (applied to the skin) may cause irritation, with redness and itching. Use has also been associated with photosensitivity (sensitivity to light) and allergic reactions. If gentamicin is applied to a large area of skin when the patient is also taking similar antibiotics by mouth or injection, there is an increased risk of side effects, including kidney damage and hearing loss. This drug is not intended for long-term use, which could result in the overgrowth of resistant bacteria or fungi.
Health products containing human placenta: Potential risks associated with the use of unauthorized human placenta products include bacterial and viral disease transmission. No health products containing human placenta have been authorized for sale by Health Canada.
Lidocaine cream is considered safe when used in small amounts and low concentrations over small areas of the body. However, J-Cain lidocaine cream is labelled to contain a 15.6% concentration, which is considered high. Health Canada has not reviewed the safety of creams containing lidocaine at a high concentration. When 15.6% lidocaine cream is applied on the body, a significant amount of lidocaine may be absorbed into the bloodstream, which may cause the buildup of toxic levels of lidocaine in the body. Symptoms of toxicity may include redness, itching, burning and swelling in the application area. In severe cases, symptoms may include irregular heartbeat, difficulty breathing, seizure, coma and death.
Stem cell therapies: Potential risks associated with the use of unauthorized stem cell therapies include bacterial and viral disease transmission. Health Canada has authorized one stem cell therapy drug (Prochymal) to date.
For more information
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SOURCE Health Canada
For further information: Media Enquiries: Health Canada, (613) 957-2983; Public Enquiries: (613) 957-2991, 1-866 225-0709