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

OTTAWA, ONTARIO--(Marketwire - Feb. 23, 2012) -

The 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.

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.

What consumers 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.



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.

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.

For more information:

Consumers and health professionals wanting more information about this advisory from Health Canada can contact the Public Enquiries Line at 613-957-2991, or toll free at 1-866-225-0709.

Media enquiries related to this Advisory should be directed to Health Canada Media Relations at 613-957-2983.

How to report side effects to health products:

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 (http://www.hc-sc.gc.ca/dhp-mps/medeff/report-declaration/index-eng.php) and send to us using one of these methods:



-- Fax: 1-866-678-6789
-- Internet: www.healthcanada.gc.ca/medeffect
-- Mail: Canada Vigilance Program
Marketed Health Products Directorate
Ottawa, ON, Address Locator 0701E
K1A 0K9



Related Health Canada Web content:

-- Advisory (July 6, 2011): 14 Additional Unauthorized Health Products Tested: May Pose Serious Health Risks (http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2011/2011_89-eng.php)

-- Advisory (July 4, 2011): "Man Up Now" Removed From Sale at Delta and Surrey Stores: May Pose Serious Health Risks to Canadians (http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2011/2011_88-eng.php)

-- Advisory (June 14, 2011): Unauthorized Health Products Removed From Sale at Burnaby and Richmond Stores: May Pose Serious Health Risks to Canadians (http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2011/2011_77-eng.php)

-- Advisory (July 13, 2010): Unapproved Health Product "UP Ultimate Performance For Men" May Pose Serious Health Risks (http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2010/2010_117-eng.php)

-- Advisory (March 8, 2010): Unapproved Health Product, "POWER-MAX" May Pose Serious Health Risks (http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2010/2010_34-eng.php)

-- Advisory (January 8, 2010) - Canadians Advised Not to use "Stiff Nights" or Any Unauthorized Product Promoted for Erectile Dysfunction (http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2010/2010_05-eng.php)

-- Advisory (December 24, 2009) - Health Canada Warns Consumers Not to Use the Unauthorized Product "RevolutionDS Weight Loss (http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2009/2009_211-eng.php)

-- Advisory (July 10, 2008) - Health Canada advises consumers not to use Purepillz unauthorized products (http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2008/2008_108-eng.php)

Stay connected with Health Canada and receive the latest advisories and product recalls using these social media tools: http://www.hc-sc.gc.ca/home-accueil/sm-ms/index-eng.php

Images of the products are available at the following address: http://media3.marketwire.com/docs/HealthCanadaEN0223.pdf