Public Communication - Health Canada Endorsed Important Safety Information on ALERTEC(R) (modafinil)



    Subject: New safety warnings regarding ALERTEC(R)(*) (modafinil) and
    serious rash, allergic reactions, and mental problems

    MONTREAL, Dec. 21 /CNW/ - Alertec(R) (modafinil) is used to relieve
excessive sleepiness due to medical conditions called narcolepsy
(uncontrollable, brief episodes of daytime sleepiness), obstructive sleep
apnea/hypopnea syndrome (breathing abnormalities during sleep) and shift work
sleep disorder. Shire Canada Inc., in consultation with Health Canada, would
like to inform you of new safety information regarding Alertec(R):

    - Alertec(R) can cause serious skin and allergic reactions.

    Stop taking Alertec(R) and seek medical attention without delay if you
have any of the following: skin rash, hives, sores in your mouth, blisters and
skin peeling; swelling of your face, eyes, lips, tongue or throat; trouble
swallowing or breathing; hoarse voice.

    - Alertec(R) is not approved for use in children for any condition.

    - Alertec(R) can cause mental problems.

    Stop taking Alertec(R) and seek medical attention if you experience
mental health problems.

    As a reminder:
    - Tell your doctor if you have any heart problems, have chest pain, or
    have had a heart attack, or if you have a history of mental problems.

    There have been rare post marketing reports of severe life-threatening
    skin reactions and allergic reactions in adults and children using
    Alertec(R).

    Two of the more severe forms of skin reaction are known as Toxic
Epidermal Necrolysis (TEN) and Stevens-Johnson Syndrome (SJS), and these may
develop quickly into a serious condition. There are no factors that are known
to predict the risk of occurrence or the severity of rash associated with
Alertec(R).

    Mental problems

    Depression, anxiety, hallucinations, mania and thoughts of suicide have
been reported in patients using Alertec(R), though these events were generally
uncommon during controlled studies. Shire Canada, Inc., has sent a letter to
Canadian health care professionals informing them of this new safety
information. You may view this letter on the website of the Marketed Health
Products Directorate of Health Canada at:
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/2007/index_e.html.
    Managing marketed health product-related adverse reactions depends on
health care professionals and consumers reporting them. Reporting rates
determined on the basis of spontaneously reported postmarketing adverse
reactions are generally presumed to underestimate the risks associated with
health product treatments. Any case of serious rash, allergic reaction, mental
problem or other serious or unexpected adverse reactions in patients receiving
Alertec(R) should be reported to Shire Canada Inc. or Health Canada at the
following addresses:

    Shire Canada Inc.
    2250 Alfred-Nobel Blvd, Suite 500
    Saint-Laurent, Quebec H4S 2C9
    Tel: 1-800-268-2772
    Fax: 514-787-2425

    Any suspected adverse reaction can also be reported to:

    Canada Vigilance Program
    Marketed Health Products Directorate
    HEALTH CANADA
    Address Locator: 0701C
    OTTAWA, Ontario, K1A 0K9
    Tel: 613-957-0337
    Fax: 613-957-0335

    To report an Adverse Reaction, consumers and health professionals may
    call toll free:
    Tel: 866-234-2345
    Fax: 866-678-6789
    CanadaVigilance@hc-sc.gc.ca
    The AR Reporting Form and the AR Guidelines can be found on the Health
Canada web site or in The Canadian Compendium of Pharmaceuticals and
Specialties.
    http://www.hc-sc.gc.ca/dhp-mps/medeff/report-declaration/form/ar-ei_form_
e.html
    http://www.hc-sc.gc.ca/dhp-mps/medeff/report-declaration/guide/ar-ei_guid
e-ldir_e.html

    For other inquiries related to this communication, please contact Health
    Canada at:
    Marketed Health Products Directorate
    E-mail: mhpd_dpsc@hc-sc.gc.ca
    Tel: 613-954-6522
    Fax: 613-952-7738

    Sincerely,

    Louis Turcotte, B. Pharm., M.Sc.
    Manager, Medical Communications
    Shire Canada Inc.
    (*) ALERTEC(R) (Trade-mark of Cephalon, Inc.)





For further information:

For further information: For media inquiries, please contact Shire
Corporate Communications at (514) 787-2435

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Shire Canada Inc.

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