Serious Skin and Hypersensitivity Reactions with Provigil
Posted on Sep 25, 2008 under symptoms of anxiety |
Cephalon has notified healthcare professionals about new safety information for Provigil (modafinil). Provigil is used to reduce excessive sleepiness in adult patients with narcolepsy and other sleep disorders. Provigil is not approved for any indication in children.
The revised labeling warns that Provigil can cause life-threatening skin reactions, including Stevens-Johnson Syndrome (SJS). Although benign rashes can also occur with this drug, the company says that it is not possible to reliably predict which rashes will be serious. Because of this, Provigil should ordinarily be stopped at the first sign of a rash, unless the rash clearly is not related to the drug.
The labeling also warns that Provigil can cause other serious hypersensitivity reactions. If a multi-organ hypersensitivity reaction is suspected, the drug should be discontinued. Patients should be told to stop taking the drug if they develop signs or symptoms suggesting angioedema or anaphylaxis.
Provigil can also cause psychiatric symptoms, including anxiety, mania, hallucinations and suicidal ideation. The company advises caution when the drug is given to patients with a history of psychosis, depression or mania. If psychiatric symptoms develop, consider discontinuing the drug.
FDA Patient Safety News: January 2008
For more information, please see our website:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript.cfm?show=71#1
Duration : 0:1:29
September 25th, 2008 at 6:18 pm
1600 mg?! Wow! …
1600 mg?! Wow! 200 mg works fine. Sorry about your problem but not sure why you took so much at once.
September 25th, 2008 at 6:18 pm
yeah i took ~1600mg …
yeah i took ~1600mg of this once, yes stupid i know. my skin started turning red and peeling, so i looked it up and thought i had steven johnson’s disease and freaked out and told my parents to take me to the hospital. ever since i ODed ive been seeing dots everywhere i go and floaters when i look in the sky. beyond regret of even touching this drug.
September 25th, 2008 at 6:18 pm
Very good!
Very good!