Provigil Prescribed for Unapproved Uses

Last Updated on June 26, 2017

Investigation Complete

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At A Glance

This Alert Affects
Patients who took Provigil (Modafinil) and developed serious side effects, such as Toxic Epidermal Necrolysis.
Damages
Provigil can lead to Stevens-Johnson Syndrome, life-threatening rashes, mental changes and allergic reactions.
Company(ies)
Cephalon
Additional Details
Provigil (Modafinil) is used to treat sleep disorders including narcolepsy, sleep apnea, hypopnea syndrome and shift work sleep disorder. Provigil may have also been prescribed for off-label uses, such as the treatment of depression, ADD, ADHD and jet lag.
Date
In Oct. 2007, Cephalon added a new warning label to Provigil to detail the risk of possible serious skin rashes and psychiatric changes.