Advisory - Herbal sleep supplement found to contain habit-forming drug



    OTTAWA, April 18 /CNW Telbec/ - Health Canada is advising consumers not
to use a product called Eden Herbal Formulations Serenity Pills II because it
contains the undeclared drug estazolam, which can be habit-forming when used
for as little as a few months. Consumers who may still have this product in
their homes are advised to consult with a health care professional before they
stop taking the pills, because of the risk of withdrawal symptoms.
    Eden Herbal Formulations Serenity Pills II is promoted as a herbal
product to relieve sleeping difficulty. The product is not authorized for sale
in Canada.
    Estazolam belongs in the class of drugs known as benzodiazepines, which
should only be prescribed by a health care professional. Estazolam should not
be used by people with an allergy to any benzodiazepines, such as Valium
(diazepam), Restoril (temazepam) and Ativan (lorazepam), or those individuals
affected by the neuromuscular disorder myasthenia gravis or by sleep apnea.
Benzodiazepines, including estazolam, should only be used by pregnant women if
absolutely necessary and with caution by the elderly and those with a history
of substance abuse. The side-effects associated with the use of products
containing estazolam vary according to the individual and can include
dizziness, drowsiness, confusion, depression, loss of memory and
hallucinations.
    Health Canada has issued three advisories on similar products since
August 2006. Salt Spring Herbals Sleep Well Dietary Supplement
(http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/2006/2006_82_e.html),
Sleepees
(http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/2007/2007_16_e.html) and
Eden Herbal Formulations Sleep Ease Dietary Supplement
(http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/2007/2007_17_e.html)
were also advertised as herbal health products to relieve sleeping difficulty,
and were found to contain the undeclared drug estazolam. None of these
products have been authorized for sale by Health Canada. Drugs and natural
health products that are authorized for sale in Canada will have either an
eight-digit Drug Identification Number (DIN), a Natural Product Number (NPN)
or a Homeopathic Medicine Number (DIN-HM) on the label. These numbers indicate
that the products have been assessed by Health Canada for safety,
effectiveness and quality.
    Eden Herbal Formulations Serenity Pills II were distributed by the
Evergreen Acupuncture Clinic in Calgary, Alberta. The clinic has stopped sale
of this product, however consumers may still have the product in their homes.
    Consumers who have purchased the product should return it to the place of
purchase. To date, no adverse reactions suspected to be associated with the
use of Eden Herbal Formulations Serenity Pills II have been reported in
Canada.
    Health Canada also advises Canadians to contact the Health Products and
Food Branch Inspectorate at 1-800-267-9675 if they find Eden Herbal
Formulations Serenity Pills II for sale in Canada.
    Consumers requiring more information about this advisory can contact
Health Canada's public enquiries line at (613) 957-2991, or toll free at
1-866-225-0709.
    To report a suspected adverse reaction to this or any other health
product, please contact the Canadian Adverse Drug Reaction Monitoring Program
(CADRMP) of Health Canada by one of the following methods:

    
    Telephone: 1-866-234-2345
    Facsimile:  1-866-678-6789

    CADRMP
    Marketed Health Products Directorate
    Tunney's Pasture, AL 0701C
    email: cadrmp@hc-sc.gc.ca

    The CADRMP adverse reaction reporting form, including a version that can
    be completed and submitted online, is located on the MedEffect
    (www.medeffect.gc.ca) portal of the Health Canada Web site.

                                         Egalement disponible en français
    




For further information:

For further information: Media Inquiries: Alastair Sinclair, Health
Canada, (613) 957-1803; Public Inquiries: (613) 957-2991, 1-866 225-0709


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