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Provigil (modafinil) - FDA WARNINGS Added To Prescribing Information Regarding Serious Rash & Hypersensitivity Reactions, & Psychiatric Symptoms
Several people in this forum have used Provigil during tx for increased energy & concentration. The FDA issued the following warning late last week.
I used Provigil for 24 weeks during the Prove 3 trial that ended for me two weeks ago and have not been taken off it yet. Since stopping tx I've been jittery and have developed a small patch of rough rash on my temples that won't go away. I have my 2 week post tx appointment this AM and will address this. FYI....
Mike
_____________________________________________________________________________________________
FDA and Cephalon notified healthcare professionals of Warnings added to
prescribing information for Provigil (modafinil). Provigil is indicated
to improve wakefulness in adult patients with excessive sleepiness
associated with narcolepsy, obstructive sleep apnea/hypopnea syndrome,
and shift work sleep disorder. The revised prescribing information
updates safety information to include warnings regarding serious rash,
including Stevens-Johnson Syndrome (SJS) and hypersensitivity reactions,
and psychiatric symptoms. Rare cases of serious or life-threatening
rash, including Toxic Epidermal Necrolysis, and Drug Rash with
Eosinophilia and Systemic Symptoms have been reported in adults and
children in worldwide postmarketing experience. Angioedema and
multi-organ hypersensitivity reactions have also been reported in
postmarketing experience.
Physicians should instruct their patients to immediately discontinue the
use of Provigil and contact them if a rash or other hypersensitivity
reaction occurs. Healthcare professionals and consumers should also be
aware that Provigil is not approved for use in pediatric patients for
any indication. In addition, psychiatric adverse experiences (including
anxiety, mania, hallucinations, and suicidal ideation) have been
reported in patients treated with Provigil. Caution should be exercised
when Provigil is given to patients with a history of psychosis,
depression, or mania.
Additional labeling revisions were made to the CLINICAL PHARMACOLOGY,
PRECAUTIONS, and PATIENT PACKAGE INSERT sections. Read the complete
MedWatch 2007 Safety Summary including a link to the manufacturer's Dear
Healthcare Professional Letter and the revised prescribing information
at: http://www.fda.gov/medwatch/safety/2007/safety07.htm#Provigil
I used Provigil for 24 weeks during the Prove 3 trial that ended for me two weeks ago and have not been taken off it yet. Since stopping tx I've been jittery and have developed a small patch of rough rash on my temples that won't go away. I have my 2 week post tx appointment this AM and will address this. FYI....
Mike
_____________________________________________________________________________________________
FDA and Cephalon notified healthcare professionals of Warnings added to
prescribing information for Provigil (modafinil). Provigil is indicated
to improve wakefulness in adult patients with excessive sleepiness
associated with narcolepsy, obstructive sleep apnea/hypopnea syndrome,
and shift work sleep disorder. The revised prescribing information
updates safety information to include warnings regarding serious rash,
including Stevens-Johnson Syndrome (SJS) and hypersensitivity reactions,
and psychiatric symptoms. Rare cases of serious or life-threatening
rash, including Toxic Epidermal Necrolysis, and Drug Rash with
Eosinophilia and Systemic Symptoms have been reported in adults and
children in worldwide postmarketing experience. Angioedema and
multi-organ hypersensitivity reactions have also been reported in
postmarketing experience.
Physicians should instruct their patients to immediately discontinue the
use of Provigil and contact them if a rash or other hypersensitivity
reaction occurs. Healthcare professionals and consumers should also be
aware that Provigil is not approved for use in pediatric patients for
any indication. In addition, psychiatric adverse experiences (including
anxiety, mania, hallucinations, and suicidal ideation) have been
reported in patients treated with Provigil. Caution should be exercised
when Provigil is given to patients with a history of psychosis,
depression, or mania.
Additional labeling revisions were made to the CLINICAL PHARMACOLOGY,
PRECAUTIONS, and PATIENT PACKAGE INSERT sections. Read the complete
MedWatch 2007 Safety Summary including a link to the manufacturer's Dear
Healthcare Professional Letter and the revised prescribing information
at: http://www.fda.gov/medwatch/safety/2007/safety07.htm#Provigil
That Was "In July" 2006 I was prescribed PROVIGIL and went to the WSOP - for clarification
In the US PROVIGIL (modafinil) Label use
PROVIGIL is a prescription medicine used to improve wakefulness in adults who are very sleepy due to one of the following diagnosed sleep disorders:
• narcolepsy
• obstructive sleep apnea (OSA). PROVIGIL is used with other medical treatments for this sleep disorder. PROVIGIL does not take the place of using your CPAP machine or other treatments that your doctor has prescribed for this condition It is important that you continue to use these treatments as prescribed by your doctor.
• shift work disorder (SWD)
http://www.provigil.com/media/PDFs/medication_guide.pdf
It's been used off label and in many trials like ADHD, cocaine addiction, etc including HVC treatment to help those better comply with treatment. FDA hasn't approved any of these uses as of now.
My personal experience.
In the 2000's I was diagnosis with sleep apnea. I remembered reading about modafinil and reports that it increased college students test taking abilities calling it a mind enhancing drug.
In July I persuaded my pulmonary doctor to prescribe it to me. Was compliant with the use of my CPAP but still tired during the day. It just so happened i was leaving for Las Vegas to play in the WSOP main event via a free entry I had won on Pokerstars. Day 1C started at 12 noon and went till 3:30 AM. I think it really helped my consecrate on my Game. I actually lasted till past the bubble day 3 to day 4 and collected about $34K.
During the fall I used it but started to feel some side effects nervousness trouble getting to sleep etc. When I went to my pulmonary doctor and my CPAP use was not compliant the doctor would never prescribe it to be again and I stop asking a couple years ago when they said they almost never use it for sleep apnea now just narcolepsy and maybe shift work disorder. For years I have been avoiding HPC genotype 2a, 2c treatment because of fear two years ago ago I ask if I could get if I started treatment and was told no.
At the VA i have talked to a couple other outpatients (not hep C) who have tried it for various conditions but they stopped because of adverse affects.
The mental health psychologist would give me wellbutrin but not modafinil.. But probably a good reason was my prior history of getting non A non B hep in 1980 from injecting cocaine. Now waiting for the VA to approve SOVALDI and Ribavarin treatment hopefully within a few months.
PROVIGIL is a prescription medicine used to improve wakefulness in adults who are very sleepy due to one of the following diagnosed sleep disorders:
• narcolepsy
• obstructive sleep apnea (OSA). PROVIGIL is used with other medical treatments for this sleep disorder. PROVIGIL does not take the place of using your CPAP machine or other treatments that your doctor has prescribed for this condition It is important that you continue to use these treatments as prescribed by your doctor.
• shift work disorder (SWD)
http://www.provigil.com/media/PDFs/medication_guide.pdf
It's been used off label and in many trials like ADHD, cocaine addiction, etc including HVC treatment to help those better comply with treatment. FDA hasn't approved any of these uses as of now.
My personal experience.
In the 2000's I was diagnosis with sleep apnea. I remembered reading about modafinil and reports that it increased college students test taking abilities calling it a mind enhancing drug.
In July I persuaded my pulmonary doctor to prescribe it to me. Was compliant with the use of my CPAP but still tired during the day. It just so happened i was leaving for Las Vegas to play in the WSOP main event via a free entry I had won on Pokerstars. Day 1C started at 12 noon and went till 3:30 AM. I think it really helped my consecrate on my Game. I actually lasted till past the bubble day 3 to day 4 and collected about $34K.
During the fall I used it but started to feel some side effects nervousness trouble getting to sleep etc. When I went to my pulmonary doctor and my CPAP use was not compliant the doctor would never prescribe it to be again and I stop asking a couple years ago when they said they almost never use it for sleep apnea now just narcolepsy and maybe shift work disorder. For years I have been avoiding HPC genotype 2a, 2c treatment because of fear two years ago ago I ask if I could get if I started treatment and was told no.
At the VA i have talked to a couple other outpatients (not hep C) who have tried it for various conditions but they stopped because of adverse affects.
The mental health psychologist would give me wellbutrin but not modafinil.. But probably a good reason was my prior history of getting non A non B hep in 1980 from injecting cocaine. Now waiting for the VA to approve SOVALDI and Ribavarin treatment hopefully within a few months.
I will post on here what I once read on a site about Provigil... get off the Internet and start enjoying your new found energy. The potential skin conditions are in bold letters under side effects... and yet the worst condition was found in ONE person, and it was never proven to be linked to the Provigil. I believe the person was quite young and had other health/autoimmune issues. By all means, if you develop a rash that concerns you consult your doctor. You should whether or not you take Provigil... but as someone who actually freaked herself out enough to read the side effect studies... consider if that is really a healthy level of concern.
Do you know what the number one side effect I and many many others have noticed most of all? ANXIETY. More specifically, PARANOIA. Really think about why you are reading these posts. I'm not saying to not be cautious, but my worry and anxiety are a large part of what exhausted me in the first place. I hope I can help at least one worrier like me :-) I am a healthy late 20's female... but I am prone to anxiety and have been treated for it.
The benefits and costs of Provigil should always be considered and discussed with your doctor.
Please take a deep breath and relax. On the off chance something goes wrong, freaking out never helps anyway!
Do you know what the number one side effect I and many many others have noticed most of all? ANXIETY. More specifically, PARANOIA. Really think about why you are reading these posts. I'm not saying to not be cautious, but my worry and anxiety are a large part of what exhausted me in the first place. I hope I can help at least one worrier like me :-) I am a healthy late 20's female... but I am prone to anxiety and have been treated for it.
The benefits and costs of Provigil should always be considered and discussed with your doctor.
Please take a deep breath and relax. On the off chance something goes wrong, freaking out never helps anyway!
I'm back from my 26 week appointment.
The doc said the rough rash on my face is from the Ribavirin & INF and not Provigil. Just the same he took me off the Provigil because I feel so jittery now that tx is done.
They drew many blood samples today and performed a elctrocariogram.
Now the waiting begins....
Mike
The doc said the rough rash on my face is from the Ribavirin & INF and not Provigil. Just the same he took me off the Provigil because I feel so jittery now that tx is done.
They drew many blood samples today and performed a elctrocariogram.
Now the waiting begins....
Mike
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