Unauthorized ExtenZe Sexual Enhancement Supplements May Pose Health Risks

Starting date:

August 19, 2010

Posting date:

August 19, 2010

Type of communication:

Advisory

Subcategory:

Drugs

Source of recall:

Health Canada

Issue:

Undeclared Substance, Product Safety

Audience:

General Public

Identification number:

RA-110003697

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The issue

Health Canada has seized the unauthorized sexual enhancement supplements "Male Enhancement ExtenZe" and "Women ExtenZe" imported and sold by the Happy Paradise Adult Store in Burnaby, British Columbia. The labels of these products list ingredients that legally require that they be sold with a prescription. Side effects may require monitoring by a health care practitioner.

Who is affected

Consumers who have purchased these unauthorized "ExtenZe" sexual enhancement supplements from the Happy Paradise Adult Store in Burnaby, British Columbia or elsewhere in Canada, including online at www.extenze.com.

What consumers 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 a single eight-digit Drug Identification Number (DIN), a Natural Product Number (NPN) or a Homeopathic Medicine Number (DIN-HM) on the label.
• Report any adverse reaction related to these products to Health Canada.

What Health Canada is doing

Health Canada has taken steps to mitigate the risk to the Canadian public by seizing these products from the retailer and informing the public of the risks associated with these unauthorized products. Health Canada will continue to monitor the sale of these unauthorized sexual enhancement supplements and will take appropriate action should the department become aware that any company is continuing to sell unauthorized health products that may pose a risk to Canadians.

According to their labels, these products are manufactured for Biotab Nutraceuticals, Inc., in Morovia, California, U.S.A. Health Canada is working with the Canada Border Services Agency to stop the importation of any shipments of unauthorized ExtenZe products from entering Canada.

Background

The ingredients listed on the labels of these products shown below can cause serious health problems. The labels of each of these unauthorized products list the prescription ingredient pregnenolone and the controlled drug, dehydroepiandrosterone (DHEA). These products 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 be avoided by individuals who suffer from epileptic seizures or who are taking anti-seizure medications.

The labels of the unauthorized "Male Enhancement ExtenZe Nutritional Supplements" list the ingredient yohimbe extract (bark). Yohimbe products contain the prescription medication yohimbine, 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, 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.

To date, Health Canada has not received any reports of adverse reactions in Canada associated with the use of "ExtenZe" products.

Products affected

1. Male Enhancement ExtenZe Nutritional Supplement
   • Packaged in boxes of 30 tablets (2 blister packs of 15 tablets). According to the label, the product contains the prescription medications yohimbine and pregnenolone, as well as the controlled drug, DHEA.
   • Same as above but packaged as 1 blister pack of 4 tablets.
2. Women ExtenZe
   • Packaged in boxes of 30 tablets (2 blister packs of 15 tablets). According to the label, the product contains the prescription medication pregnenolone, as well as the controlled drug, DHEA.

* 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 included in this list (shown below) should not be confused with any authorized products with similar names found on the Canadian market.

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

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

Related Health Canada Web Content

• Advisory (April 10, 2006) - Health Canada advises consumers not to use unapproved products containing yohimbine or yohimbe bark including Strauss Energy SIX capsules
• Advisory (May 26, 2010) - Unauthorized Healath Products Seized at YVS (Your Vitamin Store) in Burnaby, B.C.
• Advisory (September 3, 2008) - Unauthorized Health Products Found on the Canadian Market

Related AWRs

Media enquiries

Health Canada
613-957-2983

Public enquiries

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

Images

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