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Various dangerous ExtenZe products found at Calgary retailer

Starting date:
June 4, 2013
Posting date:
June 4, 2013
Type of communication:
Advisory
Subcategory:
Drugs
Source of recall:
Health Canada
Issue:
Unauthorized products
Audience:
General Public
Identification number:
RA-33881

Issue

Two unauthorized "ExtenZe" products that may pose serious risks to the health of Canadians were being sold by Saints N Sinners Ltd., 1715 Centre Street N.W., Calgary, Alberta. These products (shown below) are promoted as sexual enhancement products and are labelled to contain ingredients that require they be sold with a prescription in Canada.

What you should do

  • Consult your healthcare practitioner if you have used any of these products and are concerned about your health.
  • 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.

Who is affected

Consumers who have purchased or used either of these unauthorized "ExtenZe" products: ExtenZe Plus or ExtenZe Maximum Strength.

Background

The ingredients listed on the labels of these products can cause serious health problems. The prescription ingredient pregnenolone and the controlled drug DHEA (dehydroepiandrosterone) 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.

Additionally, 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.

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.

Media enquiries

Health Canada
(613) 957-2983

Public enquiries

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

What Health Canada is doing

Health Canada has followed up with Saints N Sinners Ltd. and removed the products from sale. Health Canada is also working with the Canada Border Services Agency to stop any shipments of any of these products from entering Canada.

Images

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