Advisory - Heartland Natural Wild Yam Moisturizing Cream contains undisclosed prescription drug ingredient

OTTAWA, May 23, 2014 /CNW/ -

The issue:

Health Canada has requested that Christmas Natural Foods Ltd. stop selling and recall its unauthorized health product, Heartland Natural Wild Yam Moisturizing Cream, after testing conducted by the Department identified a undisclosed prescription drug ingredient, progesterone. Approved drugs that contain progesterone can only be sold by prescription. Progesterone can be associated with serious side effects, including an increased risk of blood clots.

Who is affected:

Canadians who have used or purchased Heartland Natural Wild Yam Moisturizing Cream.

What consumers should do:

• Contact your health care practitioner if you have any questions or concerns regarding the use of this product.
  
• Call Health Canada's toll-free line at 1-800-267-9675 with questions or complaints about this product.
  
• Report any adverse events with this product to Health Canada.

What Health Canada is doing:

Health Canada will continue to work with the company to help ensure this product is recalled from the Canadian market. Should there be new information, Health Canada will inform Canadians, as necessary.

Background:

Progesterone is associated with side effects, in particular in certain vulnerable patients (for example, patients at risk of blood clots). Patients using this cream who are already taking progesterone-containing medications (i.e. birth control pills, hormone replacement therapy) may be at an elevated risk due to their overall progesterone exposure. Health risks most commonly arise after the long-term use of a cream containing undeclared progesterone.

Products affected:

1. Heartland Natural Wild Yam Moisturizing Cream

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 of health products to Health Canada:

• 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.

Stay connected with Health Canada and receive the latest advisories and product recalls using social media tools.

PDF available at: http://stream1.newswire.ca/media/2014/05/23/20140523_C9805_DOC_EN_40737.pdf

SOURCE: Health Canada

Media Enquiries: 
Health Canada
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Public Enquiries:
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1-866 225-0709

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