Additional ExtenZe Unauthorized Sexual Enhancement Products Removed from Sale

Starting date:

January 2, 2013

Posting date:

January 2, 2013

Type of communication:

Advisory

Subcategory:

Drugs, Affects children, pregnant or breast feeding women

Source of recall:

Health Canada

Issue:

Important Safety Information

Audience:

General Public

Identification number:

RA-16427

• Issue
• What you should do
• Who is affected
• Background
• Report health or safety concerns
• Related AWRs
• Media enquiries
• Public enquiries
• What Health Canada is doing
• Images

Issue

Four unauthorized natural health products have been removed from sale as they may pose serious risks to the health of Canadians. The “ExtenZe” products (shown below) are promoted as sexual enhancement products and contain ingredients that legally require they be sold with a prescription in Canada.

The products were being sold at the following locations: www.Lovedreamer.com, 2583 Yonge St., Toronto, and at 65 Martin Ross Ave., Downsview, Ont. It is important to note that these products may have been sold elsewhere on the Canadian market.

What you should do

• Consult your healthcare practitioner if you have used any of these products and are concerned about your health.
• Contact the place of purchase.
• 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 Natural Product Number (NPN) or a Homeopathic Medicine Number (DIN-HM) on the label. Some natural health products 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.
• Report any adverse reaction related to these products to Health Canada (see below).

Who is affected

Consumers who have purchased any of these unauthorized “ExtenZe” products: ExtenZe Max Strength Gelcaps, ExtenZe Original Tablets, ExtenZe Natural Female Tablets, and ExtenZe Big Cherry Flavour Liquid.

Background

The ingredients listed on the labels of these products can cause serious health problems. Three of these unauthorized products list the prescription ingredient pregnenolone and the controlled drug DHEA (dehydroepiandrosterone). These substances can cause higher than normal levels of female and male hormones in the body and could increase the risk of prostate, breast, ovarian, and other hormone-sensitive cancers.

DHEA should be avoided by individuals with a history of abnormal heart rhythms, blood clotting disorders and liver disease, while pregnenolone should not be used by women who are pregnant or breast-feeding, and should be avoided by individuals who suffer from epileptic seizures or who are taking anti-seizure medications.

Three of these unauthorized products contain the prescription medication yohimbine (either as yohimbine HCl or as yohimbe extract), which has been associated with anxiety, dizziness, increased blood pressure, fast heart rate and may result in serious adverse reactions, particularly in people with high blood pressure, or heart, kidney or liver disease.

If you have taken products containing these ingredients without the supervision of a health care practitioner or without a prescription, you may face additional risks. The treatment might not be appropriate and you may miss the opportunity to obtain proper medical treatment. You may also put yourself at risk for drug interactions, or harmful side-effects.

Consumers should be aware that there may be authorized alternatives for similar products in Canada that would be labelled in English and French. The names of unauthorized products listed above should not be confused with any authorized products with similar names found on the Canadian market.

Report health or safety concerns

• Call toll-free at 1-866-234-2345
• Visit MedEffect Canada's web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax.

Related AWRs

Media enquiries

Health Canada
(613) 957-2983

Public enquiries

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

What Health Canada is doing

Health Canada is requesting a stop-sale of these products and informing the public of the risks associated with the use of them. Health Canada will continue to monitor the sale of ExtenZe unauthorized products and will take appropriate action should it become aware that any company is continuing to sell unauthorized health products that may pose a risk to Canadians.

Health Canada is working with the Canada Border Services Agency to stop any shipments of unauthorized ExtenZe products from entering Canada.

Images

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