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Public advisory

Seizure of Potentially Dangerous Products at Ontario's The Love Shop

Starting date:
February 23, 2012
Posting date:
February 23, 2012
Type of communication:
Advisory
Subcategory:
Drugs
Source of recall:
Health Canada
Issue:
Product Safety, Unauthorized products, Undeclared Substance
Audience:
General Public
Identification number:
RA-110005352

Issue

Health Canada seized a variety of Stiff4Ever and PurePillz products from The Love Shop retail outlets located in Ontario. These products are unauthorized drugs and are considered potentially dangerous to the health and safety of Canadians.

Health Canada tested the Stiff4Ever products, advertised as male sexual stimulants, and identified undeclared prescription medications in the products. The labels of the PurePillz products (see below) state that they contain BZP and TFMPP. Health Canada is considering the addition of BZP and TFMPP to Schedule III to the Controlled Drugs and Substances Act and the Schedule to Part J of the Food and Drug Regulations.

What you should do

  • Speak to your healthcare practitioner with any questions or concerns regarding these products.
  • Report any adverse reaction potentially related to these products to Health Canada (see below).
  • Read the label of the products you buy to verify that they have been assessed by Health Canada for safety, effectiveness and quality. Health products that have been authorized for sale by Health Canada will have an eight-digit Drug Identification Number (DIN), a Homeopathic Medicine Number (DIN-HM) or a Natural Product Number (NPN) on the label. Some natural health products (NHPs) may have an Exemption Number (EN), which indicates that the product is legally available for sale while Health Canada is reviewing its application for licensing.

Who is affected

Canadians who have purchased any of the PurePillz products or the Stiff4Ever products. Pregnant or nursing women and children, individuals taking any nitrate drug (e.g. nitroglycerine) and those with a history of heart problems or stroke may be at increased risk.

Background

Stiff4Ever:

Sildenafil is a prescription medication that should only be used under the supervision of a health care practitioner. Products containing sildenafil should never 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 including high blood pressure, a history of heart attack, stroke, abnormal heart beat or chest pain are at higher risk of cardio-vascular side effects if they engage in sexual activity, including if they use sildenafil to help them achieve an erection. Other possible side-effects of using sildenafil include headache, facial flushing, indigestion, dizziness, abnormal vision and hearing loss.

The risk of serious complications requires that yohimbine, a prescription drug, should only be taken under the supervision of a health care practitioner. Yohimbine should not be used by pregnant or nursing women, or children.

As of today, Health Canada has not received any adverse reactions reports associated with the use of these products.

PurePillz:

Benzylpiperazine (BZP) is a synthetic substance with stimulant-like effects, while 3-trifluoromethylphenylpiperazine (TFMPP) is a synthetic substance with hallucinogen-like effects. BZP and 3-TFMPP have no known therapeutic use. While BZP is frequently claimed to be a "natural" substance, it is a synthetic substance. These substances may cause adverse effects such as increased body temperature, increased blood pressure and heart rate, abnormal heart rhythm, nausea, vomiting, and kidney damage.

Other reported adverse effects include confusion, agitation, anxiety, hallucinations, paranoia, seizures, and convulsions. These substances could also negatively interact with other substances, such as alcohol and prescription drugs. As such, ingestion of BZP and/or TFMPP, alone or with other drugs, poses a significant health risk to users. Scientific data also indicates that BZP has abuse potential because of its amphetamine-like effects. The long-term side effects of using BZP and/or TFMPP are unknown. Health Canada advises Canadians to avoid products with these substances.

Report health or safety concerns

To report suspected adverse reaction to these or other health products, please contact Health Canada's Canada Vigilance Program toll-free at 1-866-234-2345, or complete a Canada Vigilance Reporting Form and send to us using one of these methods:

Fax: 1-866-678-6789
Internet: MedEffect Canada
Mail: Canada Vigilance Program
Marketed Health Products Directorate
Ottawa, ON, Address Locator 0701E
K1A 0K9


Media enquiries

Health Canada
613-957-2983

Public enquiries

613-957-2991
1-866-225-0709

What Health Canada is doing

Health Canada has requested that The Love Shop stop distributing unauthorized health products to their retail stores and recall these potentially dangerous products from the Canadian market.

Images

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