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

Starting date:
April 18, 2007
Posting date:
April 18, 2007
Type of communication:
Advisory
Subcategory:
Drugs
Source of recall:
Health Canada
Issue:
Unauthorized products
Audience:
General Public
Identification number:
RA-110001963

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, Sleepees and Eden Herbal Formulations Sleep Ease Dietary Supplement 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 portal of the Health Canada Web site.


Media enquiries

Alastair Sinclair
Health Canada
(613) 957-1803

Public enquiries

(613) 957-2991
1-866 225-0709