Advisory - Health Canada suspends licence for Performance Plus capsules: Product may pose serious health risks

OTTAWA, Feb. 11, 2020 /CNW Telbec/ -

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Summary

• Product: Performance Plus capsules (NPN 80053999)
• Issue: Product may pose serious health risks. Product testing found that a prescription drug (sildenafil) was not listed on the label.
• What to do: Stop using this product. Consult your healthcare professional if you have used this product and have health concerns.

IssueHealth Canada is advising Canadians that it has suspended the product licence for Performance Plus capsules because it may pose serious health risks, such as heart attack and stroke. Performance Plus is distributed by TW Trade and promoted as a natural health product for sexual enhancement. Health Canada laboratory testing found that it contains a prescription drug (sildenafil) that is not listed on the product label.

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

A suspended licence means that it is illegal to sell this product.

Who is affectedConsumers who have bought or are using Performance Plus capsules.

Affected productPerformance Plus capsules (NPN 80053999). The product comes in packages containing blister packs of 2 or 10 capsules.

What consumers should do

• Stop using this product.
• Consult your healthcare professional if you have used this product and have health concerns.
• Report any health product-related adverse reactions or complaints to Health Canada.

What Health Canada is doingIn October 2019, Performance Plus capsules were voluntarily recalled by TW Trade because of a labelling issue (the lot numbers and expiry dates printed on the carton did not match those on the blister packs). Health Canada found that TW Trade was operating without the necessary site licence and directed the company to stop all licensable activities. Operating without the required licence is a serious contravention of the Natural Health Products Regulations. A site licence indicates that a company has processes and procedures in place that meet Health Canada's requirements, including those related to tracking and recalling health products when health risks are identified.

After becoming aware that the product continued to be sold after the recall in October 2019, Health Canada seized the product from two Ontario adult stores owned by TW Trade (Love Shop in Guelph and Brampton). The Department also seized the product and packaging from TW Trade and conducted laboratory testing, which identified the presence of the prescription drug, sildenafil. Should additional safety concerns be identified, Health Canada will take appropriate action and inform Canadians as necessary.

BackgroundSildenafil is a prescription drug used to treat erectile dysfunction and should be used only under the supervision of a health care professional. It should not be used by individuals taking any kind of nitrate drug (e.g., nitroglycerine) as it can cause potentially life-threatening low blood pressure. Individuals with heart problems are at increased risk of cardiovascular side effects such as heart attack, stroke, chest pain, high blood pressure and abnormal heartbeat. Other possible side effects include headache, facial flushing, indigestion, dizziness, abnormal vision, and hearing loss.

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SOURCE Health Canada