Advisory: Health Canada Informs Pregnant and Breastfeeding Women Not to Take Vitamin Maxum Matragen and/or Maxum Multi

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Mon May 25, 2009 2:15pm EDT

  OTTAWA, ONTARIO, May 25 (MARKET WIRE) -- 
Health Canada is advising expectant mothers and breastfeeding women not
to take the vitamin-mineral supplements Maxum Matragen or Maxum
Multi-Vite by Seroyal International Inc. Maxum Multi-Vite has been
approved as a vitamin-mineral supplement for only the general public but
lacks the required cautionary statement on the label regarding pregnant
and/or breast feeding women. The product Maxum Matragen is being promoted
by the company as a prenatal supplement; however, neither product has
been authorized for sale by Health Canada for use by women who are
pregnant or breastfeeding.

    Both products contain ingredients such as Ginkgo biloba, Green Tea
Extracts and Vanadium, whose safe use during pregnancy or in
breastfeeding women has not been well established. Products containing
these ingredients require a cautionary label warning consumers to consult
with a health care practitioner prior to use if they are pregnant or
breastfeeding, neither Maxum Matragen nor Maxum Multi-Vite carries such a
warning on their labels.

    In addition, the daily doses as labelled for Maxum Matragen and Maxum
Multi Vite do not provide the minimum recommended daily dose of 400 mcg
of folic acid and the recommended 16-20 mg of iron for expectant,
pregnant and breastfeeding women.

    Health Canada has not received any adverse reaction reports associated
with Maxum Matragen and/or Maxum Multi-Vite. Pregnant or breastfeeding
women who may be taking Maxum Matragen or Maxum Multi-Vite are advised to
consult their health care professional prior to continuing use of these
products.

    The company Seroyal International Inc. has voluntarily recalled these
products from the market.

    Please visit the Public Health Agency of Canada's website
(http://www.phac-aspc.gc.ca/hp-gs/index-eng.php) for more information on
healthy living during pregnancy.

    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.

    You can report any adverse reactions associated with the use of health
products to the Canada Vigilance Program by one of the following three
ways:

    - Report online
(http://www.hc-sc.gc.ca/dhp-mps/medeff/report-declaration/index-eng.php)
at the MedEffect(TM) Canada Web site (www.healthcanada.gc.ca/medeffect)

    - Call toll-free at 1-866-234-2345

    - Complete a Canada Vigilance Reporting Form
(http://www.hc-sc.gc.ca/dhp-mps/medeff/report-declaration/ar-ei_form-eng.php)
and either:


         - Fax toll-free to 1-866-678-6789

         - Mail to: Canada Vigilance Program
                    Health Canada
                    AL 0701C
                    Ottawa, ON K1A 0K9


    To have postage pre-paid, download the postage paid label
(http://www.hc-sc.gc.ca/dhp-mps/medeff/report-declaration/post_paid-affranchi-en
.php)
from the MedEffect(TM) Canada Web site
(http://www.hc-sc.gc.ca/dhp-mps/medeff/index-eng.php). The Canada
Vigilance Reporting Form
(http://www.hc-sc.gc.ca/dhp-mps/medeff/report-declaration/ar-ei_form-eng.php)
and the adverse reaction reporting guidelines may also be obtained via
this website.

    Egalement disponible en francais

Contacts:
Media Inquiries:
Health Canada
613-957-2983

Public Inquiries:
613-957-2991
1-866-225-0709

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