Archived - New warnings regarding ALERTEC (modafinil) and serious rash, allergic reactions, and mental problems - For the Public

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^®:

• Alertec^® can cause serious skin and allergic reactions.
  
  Stop taking Alertec^® 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^® is not approved for use in children for any condition.
• Alertec^® can cause mental problems.
  
  Stop taking Alertec^® 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 ^®.

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:

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 incident 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 or 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.

For other inquiries related to this communication, please contact Health Canada at:

Marketed Health Products Directorate (MHPD)

E-mail: mhpd_dpsc@hc-sc.gc.ca

Tel.: 613-954-6522

Fax: 613-952-7738

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.)