Health Canada

Health Canada

December 10, 2010 09:57 ET

Health Product Kit: "Flat Stomach Concept Extra" May Pose Serious Risk to Health

OTTAWA, ONTARIO--(Marketwire - Dec. 10, 2010) -

Editors Note: A photo for this release is available via Marketwire's website.

The issue:

Health Canada has been advised that "Flat Stomach Concept Extra" is being voluntarily recalled by Les Produits Naturels Leblanc Inc due to missing label statements related to duration of use, risks and contraindications. Information missing from the label of Flat Stomach, a product contained within the Flat Stomach Concept Extra kit, may result in potential chronic use of aloe, which can lead to bowel dependence, and electrolyte imbalance.

As such, serious adverse effects including irregularities in heart beat (cardiac arrhthymias), muscular weakness, kidney failure and even death may occur. To date, Health Canada has not received any adverse reactions regarding "Flat Stomach Concept Extra".

Who is affected:

Canadians who have used this product, especially people with immune-compromised conditions.

What consumers should do:

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 by Les Produits Naturels Leblanc Inc.

Background:

The product "Flat Stomach", a product contained within the Flat Stomach Concept Extra kit, has been authorized for sale by Health Canada under NPN 80004927 for the purposes of relieving occasional constipation and maintaining intestinal flora. However, as part of the conditions of market authorization, the product label was to include a cautionary statement advising consumers to first consult a health care practitioner if they intended to use the product for more than 5 days.

It is important to note that this statement was not included on the label of the marketed product which contravened the conditions of market authorization and also presented potentially severe risks to the health and safety of Canadians following long-term use.

Stimulant laxatives should not be taken for more than 1-2 weeks unless under the supervision of a health care practitioner. Chronic use of aloe products can irreversibly damage the intestine, and disturb electrolyte balances, leading to irregularities in heartbeats, muscular weakness, kidney failure and even death. The product "Flat Stomach" also contains a diuretic ingredient, which may increase the potential for adverse effects on blood electrolyte levels.

Products affected:

Flat Stomach Concept Extra : http://media3.marketwire.com/docs/ventreplat.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 the Canada Vigilance Program of Health Canada toll-free at 1-866-234-2345, or complete a Canada Vigilance Reporting Form and send 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:

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/).

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Contact Information

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