New warnings regarding ALERTEC^{® *} (modafinil) and serious rash, allergic reactions, and mental problems

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Contact: Marketed Health Products Directorate (MHPD)

The Health Products and Food Branch (HPFB) posts on the Health Canada web site safety alerts, public health advisories, press releases and other notices as a service to health professionals, consumers, and other interested parties. These advisories may be prepared with Directorates in the HPFB which includes pre-market and post-market areas as well as market authorization holders and other stakeholders. Although the HPFB grants market authorizations or licenses for therapeutic products, we do not endorse either the product or the company. Any questions regarding product information should be discussed with your health professional.
 
This is duplicated text of a letter from Shire Canada Inc.
Contact the company for a copy of any references, attachments or enclosures.

Public Communication
Health Canada Endorsed Important Safety Information on
ALERTEC^® (modafinil)

December 21, 2007

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

Alertec^® (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^®:

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 ^®.
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^®.

Mental problems
Depression, anxiety, hallucinations, mania and thoughts of suicide have been reported in patients using Alertec ^®, 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.

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 post-marketing 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^® should be reported to Shire Canada Inc. or Health Canada at the following addresses:

For media inquiries, please contact Shire Corporate Communications at 514-787-2435.

Sincerely,

original signed by

Louis Turcotte, B. Pharm., M.Sc.
Manager, Medical Communications
Shire Canada Inc.

^* ALERTEC^® (Trade-mark of Cephalon, Inc.)