Health Canada suspends two natural health product licences due to potential serious risks of male fern

Starting date:

April 2, 2015

Type of communication:

Advisory

Subcategory:

Drugs

Source of recall:

Health Canada

Issue:

Important Safety Information, Product withdrawal

Audience:

General Public

Identification number:

RA-52807

• Issue
• Products affected
• What you should do
• Who is affected
• Background
• Report health or safety concerns
• Related AWRs
• Media enquiries
• Public enquiries
• What Health Canada is doing

Issue

Health Canada has suspended the licences of two natural health products containing the ingredient male fern (Dryopteris filix-mas), "Paranil" and "W.-W. Safety information has raised potential concerns regarding effects of the specific ingredient at higher doses, and as such consumers should stop using the affected products immediately as they may pose a serious health risk.

Products affected

• W.-W (NPN: 80055739); 537 milligrams per day taken for 7 days
• Paranil (NPN: 80036362); 2 grams per day taken once

What you should do

• Speak to your healthcare practitioner if you have used W.-W and have concerns about your health.
• Report any adverse events to Health Canada.

Who is affected

Consumers who have purchased or used W.-W. are affected. Paranil has not been sold on the Canadian market.

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.

Report health or safety concerns

• 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.

Related AWRs

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 holders, Natures Formulae Health Products Ltd. (Paranil) and Les Herbes Pures J.B. Ltée (W.-W), of the suspensions. These products can no longer be sold on the Canadian market.

According to Natures Formulae Health Products Ltd., Paranil was never sold in Canada. Les Herbes Pures JB Ltée has agreed to stop sale and recall W.-W (limited distribution of 169 bottles). Health Canada is monitoring the recall and will inform Canadians should new information become available.

As of April 1, 2015, Health Canada had not received any adverse reaction reports associated with W.-W.