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Health Canada Endorses Safety Information on Modafinil (Alertec)

OTTAWA, CANADA -- December 21, 2007 -- Shire Canada Inc., in consultation with Health Canada, is releasing new warnings concerning modafinil (Alertec). The Product Monograph has been updated to include the following new warnings and important safety information:

· Modafinil can cause life-threatening skin and other serious hypersensitivity reactions:

- Severe cutaneous adverse reactions (SCARs), including toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome (SJS), and drug rash with eosinophilia and systemic symptoms (DRESS), have occurred in adults and children using modafinil.
- Angioedema, anaphylactic reaction, and multi-organ hypersensitivity reactions, including at least one fatality, have also been reported with the use of modafinil.
· Modafinil is not approved for use in paediatric patients for any indication.
· Modafinil can cause psychiatric symptoms.
· Also, the company is recommending that modafinil not be used in patients with a history of left ventricular hypertrophy or in patients with clinically significant manifestations of mitral valve prolapse in association with central nervous system stimulant use.

Serious Rash, Including Stevens Johnson Syndrome, and Hypersensitivity Reactions
Rare cases of TEN or SJS have been reported in adults and children who received modafinil treatment, including one non-fatal case in Canada. For modafinil, the postmarket reporting rate of TEN and SJS exceeds the background incidence rate (one to two cases per million person-years) in the general population. Reporting rates are generally accepted to be an underestimate due to under-reporting.

Although benign rashes also occur with modafinil, it is not possible to reliably predict which rashes will prove to be serious. Accordingly, modafinil should ordinarily be discontinued at the first sign of rash, unless the rash is clearly not drug-related.

Instruction for Patients
Physicians should instruct their patients to immediately discontinue the use of modafinil and contact them if a rash or any signs or symptoms suggesting angioedema or anaphylaxis occurs.

Psychiatric Symptoms
Psychiatric adverse experiences have been reported in adult and paediatric patients treated with modafinil. Caution should be exercised when modafinil is given to patients with a history of psychosis, depression or mania. Consideration should be given to the possible emergence or exacerbation of psychiatric symptoms in patients treated with modafinil. If psychiatric symptoms develop, consider discontinuing modafinil.

Please refer to the attached Product Monograph Safety Revisions for complete revisions and updates.

Patients are being advised to stop taking modafinil and to seek medical attention without delay if they have any of the following: skin rash, hives, sores in the mouth, blisters and peeling skin; swelling of the face, eyes, lips, tongue or throat; trouble swallowing or breathing; hoarse voice, or if they experience mental problems. (See the Public Communication associated with this Letter).

Modafinil (Alertec) is indicated for the symptomatic treatment of excessive sleepiness in patients with narcolepsy, obstructive sleep apnoea/hypopnoea syndrome and shift work sleep disorder.

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, anaphylactic reaction, hypersensitivity reaction, psychiatric symptom or other serious or unexpected adverse reactions in patients receiving modafinil 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 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
E-mail: mhpd_dpsc@hc-sc.gc.ca
Tel: 613-954-6522
Fax: 613-952-7738


Should you have any questions regarding Alertec or require a copy of the revised Alertec Product Monograph, please contact Shire Canada's medical information department at 1-800-268-2772.


*Alertec is a trade-mark of Cephalon, Inc.


SOURCE: Health Canada

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