Health Canada

Health Canada

January 07, 2011 11:18 ET

Synerate: Weight Loss Product Could Cause Serious Adverse Reactions

OTTAWA, ONTARIO--(Marketwire - Jan. 7, 2011) -

The issue:

The product Synerate, manufactured for Strive and distributed by Upper 49th, is being voluntarily recalled from the Canadian market because of the risk of serious, potentially fatal adverse effects from the combination of the ingredients in the product.

Synerate, a product used for weight loss or body building, contains caffeine and synephrine, which is similar to ephedrine. When used in combination with caffeine and other stimulants, synephrine and/or ephedrine has caused reported adverse events ranging from dizziness, tremors, headaches and irregularities in heart rate to seizures, psychosis, heart attacks and stroke.

The product is not authorized by Health Canada and bears no Drug Identification Number (DIN), Natural Health Product Number (NPN), Homeopathic Medicine Number (DIN-HM) or Exemption Number (EN).

Who is affected:

Canadians who have purchased or used the product Synerate manufactured for Strive and distributed by Upper 49th.

What consumers should do:

  • Consult your healthcare practitioner with any questions or concerns regarding use of this product.

  • 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.

  • Report any adverse reaction potentially related to this product to Health Canada (see below).

What Health Canada is doing:

Health Canada will monitor the voluntary recall conducted by Upper 49th.

Background:

Synerate products for sales were distributed by Upper 49th to retail stores earlier in 2010. This product may also have been distributed as part of a kit with t-shirts as well as product samples.

Several health advisories have been issued by Health Canada warning Canadians about products containing synephrine/ephedrine/ephedra, in combination with caffeine and other stimulants, for purposes of weight loss, body building or increased energy.

Products affected:

1. Synerate

To view a photo of the product, please visit the following link: http://media3.marketwire.com/docs/synerate_big.jpg

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:

Guidelines for synephrine in natural health products: http://www.hc-sc.gc.ca/dhp-mps/prodnatur/legislation/docs/notice-avis-synephrine-eng.php.

HC has also issued a number of advisories regarding ephedrine/caffeine products, which are similar to synephrine products: http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2008/2008_41-eng.php

It's Your Health on the Safe Use of Health Products for Weight Loss: http://www.hc-sc.gc.ca/hl-vs/iyh-vsv/med/weight-amaigr-eng.php

Send us your feedback: Help improve Health Canada's risk communications by sharing your thoughts on the new format for our Advisories (http://surveys-sondages.hc-sc.gc.ca/s/adv-temp-mod-avis/langen/).

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

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Contact Information

  • Media Inquiries:
    Health Canada
    613-957-2983
    or
    Public Inquiries:
    613-957-2991
    1-866-225-0709