ALERTEC
Posted Monday 24 December 2007 - 11:14 AM by David Chan (
HIGH
significance )
ATC Code
N06BA07
Warning
* Modafinil can cause life-threatening skin and other serious hypersensitivity reactions:
o 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.
o 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 pediatric patients for any indication.
* Modafinil can cause psychiatric symptoms.
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