alertec

New warnings from Health Canada for ALERTEC (modafinil):

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Submitted by sailajabyrisetty on Wed, 02/06/2008 - 00:34.
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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.

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