Health Canada has suspended the licences of two natural health products containing the ingredient male fern (Dryopteris filix-max), “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
Who is affected: Consumers who have purchased or used W.-W. are affected. Paranil has not been sold on the Canadian market.
What consumers 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.
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 Pure JB Ltée has agreed to stop sale and recall W.-W (limited distribution of approximately 360 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.
Background:
Male fern was traditionally used to expel intestinal tapeworms in therapeutic doses of one 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.
