Serious Skin and Hypersensitivity Reactions with Provigil

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

Category:

Education

Tags:

• narcolepsy
• sleep
• apnea
• skin
• rash
• allergy
• provigil
• modafinil
• anaphylaxis
• cephalon
• disorders

[RDDA86]

While I sympathize with your situation, I find that you're clearly exaggerating.

Every drug, even the safest, has rare side-effects - whether you suffer from them or not, is largely based on your genetic make-up and environment.

For an instance, penicillin (greatest medical achievement of all time) can cause a Type I Hypersensitivity reaction which can prove FATAL. So we should ban penicillin?

So, while understandable, your comment isn't really helpful at all.

[BangkokPoet]

1600 mg?! Wow! 200 mg works fine. Sorry about your problem but not sure why you took so much at once.

[esmailalfar123]

Does the rash go away when you stop using provigil right away ? Help someone I need to know plz you tube viewers my email is alfaresmail@yahoo.com

[MeatCatCheesyBlaster]

I've been taking the generic brand "Modalert" for a few months only 100mg a day. Today I woke up and found that my arm was itching. I scratched it a lot, thinking I had just scraped it on something earlier. Then I noticed I had the same shit on my other arm. I've never had a rash in my life (except chicken pox) I'm going to discontinue using this stuff immediately. If you can get this from the name brand stuff just imagine how bad the stuff from India is. Just throwing this out there.

[xxero521]

That's you. I hadn't seen them untill after I ODed.

[ilovesilvia69]

dude, iv always seen floaters. you're just being a hypochondriac.

[xxero521]

ohh ok. hope i didnt sound like a dick or anything.

Anyways it could've been way worse and all that came out of it is the dots and floaters.. i hope.. and it was my own fault.. soo no need to be sorry :)

[Droyd21]

English is not my native language so I had to ask, thanks btw.

It's said that this drug has little sideeffects when used in the right dose, but it is always good to be aware that it may cause permanent damage in some circumstances...sorry to hear about your case.

[xxero521]

Yeah i dont even know why, which is part of why it was so stupid. yeah my pill days are over. its all about crack and heroin now. lol jp im sticking to weed.

[xxero521]

there little amoeba looking things you see when you look at the sky. cmon man just use google :P

[Droyd21]

what are floaters?