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Health Canada suspends licence of homeopathic product due to potential serious risks of male fern

Starting date: April 17, 2015 Posting date: April 17, 2015 Type of communication: Advisory Subcategory: Natural health products Source of recall: Health Canada Identification number: RA-52985

Issue

Health Canada has suspended the licence of Filix Mas, a homeopathic product, because it contains the ingredient male fern (Dryopteris filix-mas). Safety information has raised potential concerns regarding effects of the specific ingredient at higher doses, and as such consumers should stop using the affected product immediately as it may pose a serious health risk. On April 2, 2015, Health Canada suspended the licences of two natural health products containing male fern.

Products affected

Filix Mas (DIN-HM 80018123)

What you should do

Speak to your healthcare practitioner if you have used Filix Mas and have concerns about your health.

Report any adverse events to Health Canada.

Who is affected

Consumers who have purchased or used Filix Mas.

Background

Male fern was traditionally used to expel intestinal tapeworms in therapeutic doses of 1 gram to 15.5 grams. Based on current safety information, Health Canada has identified that products containing male fern at these levels may cause adverse effects including liver damage, blindness and death. It is important to note that male fern is not used widely and has limited use in small populations of patients.

How to report side effects to 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.

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Media enquiries

Health Canada

(613) 957-2983

Public enquiries

(613) 957-2991

1-866 225-0709

What Health Canada is doing

Based on current safety information, Health Canada has advised the licence holder, Boiron Canada Inc., of the suspension. This product can no longer be sold on the Canadian market. Boiron has agreed to stop sale and recall Filix Mas. Health Canada is monitoring the recall and will inform Canadians should new information become available.