New warnings from Health Canada for ALERTEC (modafinil):

Alertec is used for the symptomatic treatment of excessive sleepiness in patients with narcolepsy, obstructive sleep apnea/hypopnea syndrome and shift work sleep disorder.

Shire Canada Inc. in consultation with Health Canada announced new warnings concerning modafinil ( Alertec) as it can cause severe cutaneous adverse reactions, serious hypersensitivity reactions and psychiatric symptoms. Accordingly, the product monograph has been updated to include the following new warning 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), Steven-Johnson syndrome (SJS), and Drug Rash with Eosinophilia and systemic Symptoms (DRESS), have occurred in adults and children using modafinil.

* Angioedema, anaphylactic reactions, 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 pediatric patients for any indication.
• Modafinil can cause psychiatric symptoms.
• It is also recommended that modafinil not to 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.
Patients are advised to stop taking modafinil and to seek medical attention without delay if they experience any of these symptoms , 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 any mental problems.