For all of you that have been prescribed Provigil (modafinil) for MS-related fatigue: the FDA has issued a warning that Provigil has been linked to serious skin rashes and psychiatric symptoms.
Instead of me trying to restate these warnings, I give you this, straight from the FDA letter:
- Skin rashes: "Rare cases of serious or life-threatening rash, including SJS (Stevens-Johnson Syndrome), Toxic Epidermal Necrolysis (TEN), and Drug Rash with Eosinophilia and Systemic Symptoms (DRESS) have been reported in adults and children in worldwide post-marketing experience. The reporting rate of TEN and SJS associated with modafinil use, which is generally accepted to be an underestimate due to underreporting, exceeds the background incidence rate. Estimates of the background incidence rate for these serious skin reactions in the general population range between 1 to 2 cases per million-person years."
- "Psychiatric adverse experiences (including anxiety, mania, hallucinations, and suicidalideation) have been reported in patients treated with modafinil. Caution should be exercised when PROVIGIL is given to patients with a history of psychosis, depression, or mania. If psychiatric symptoms develop in association with PROVIGIL administration, consider discontinuing PROVIGIL."
The likelihood of this happening is small, and I’ll tell you what. If my Provigil gets taken away there WILL be a raving psycho woman here! I love it, it keeps me awake during the day without the “heebie-jeebies” feeling.
If I had to give up my Provigil, I would be in bed all day.
Well, I am alive (THANK GOD!!!) today, to warn other’s that Provigal, may be a “life saver,” to other’s BUT, it is also life threatening!!! As, I am living proff. I was prescribed Provigal, for A.D.D./fatigue, last year. With-in moment’s of taking the recommended dose, I began to feel as if my upper body, (arm’s and chest,) were on fire… Then small blister’s started to appear all over. I went to the E.R. and was let go, with a prescrption for “Hive’s,” EVEN WORSE, also, Scabie’s,” I was horrified of the thought of the lader!!! I went straight home, and felt as though i was “un-clean,” which is so NOT TRUE!!! The night was one of pain, and torture, as more blister’s started to appear ALL OVER MY FACE, LIP’S, EYE’S, AND BODY!!! I was unable to walk, go to the bathroom, without severe burning and complete agony. I once AGAIN, returned to the E.R. this time, I was told, “You won’t be going home, anytime soon!!!” They started fluids, Benadryl, Steriod’s, and such intervainously. They still did’nt have a diagnosis. I told the’ the medication’s that I take, still nothing. I was transferred to another hospital,(I was also seen by, Dr. Grossman, of the world famous Grossman Burn Center, in California) still no answer’s…. Thank the Lord, the good doctor, at this hospital, took skin gragh’s, and found the culprit. Steven Johnson Syndrome!!! I was told by Dr. Grossman, that if/when I am able to stand ANY water/shower, to prepare myself for this: “Your skin is going to litterly peel/fall off in chunks, once water is present. ” It was total agony in everyway.” That apparent shower, did not take place for week’s as I was’nt able to move. Even the pain reliever that was administrated to me, was useless. My sister looked up Steven Johnson Syndrome, and sure enough the “2nd Doctor, (Wienberg) was RIGHT.) I cannot even finish this as the memories are to vivad…As are all the scar’z and discoloration that has given me an inferiority complex all over my body….I am so tired of the stare’s I receive because of this. It has and will effect me for my lifetime. SO, PLEASE UNDERSTAND THAT THOUGH RARE, IT CAN HAPPEN TO YOU, TOO!!! Thank you, Sharon Vaughn ( the woman with mark’s/scarring all over, not to mention, I am also losing precious eye-sight/constant headaches..
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Provigil has given me some of my life back.
It enables me to work full time, though my personal life has taken a terrible toll. My only complaint is its cost, unfortunately, it is so expensive.
To me, this medicine is like a diabetic’s insulin. I must have it to live.
I was dianosed with narcolepsy in 1979 and obstructive sleep apena in 1980.
I was originally prescribed amphetamines as a maintenance medication for the narcolepsy. My neurologist tried various medications as they became available but only the provigil has been somewhat successful in dealing with the narcolepsy. If the amphetamines are not useable and the provigil is not usable, what is a person with narcolepsy supposed to do?
For me, to eliminate the ability to use provigil would be the equivalent of forcing me to live without treating the narcolepsy (the provigil was supposed to get me away from the amphetamines). Such an action is analogous to playing russian roulette with my life, and quite possibly with someone else’s life at the same time.
Surely it is understood that many people like myself enjoy a quality of life that would not be possible without provigil. Given there are people who should not take provigil, is that any reason to condemn the rest of us who tolerate the medication well and still need to use it?
I respect all that have found some form of relief using provigil ! Unfortunatly I had a bad experience which I warn others about. I began taking provigil which worked pretty well for me until a doctor (knowing that I was using provigil for ms fatique) prescribed an anti depressant. I specifically asked walmart pharmacy for info on any problem with mixing the meds and they said it was ok. I took them and ended up suicidal with extreme depression. I knew something was wrong but was hysterical and out of control long before figuring it out…. Not able to think clearly. I am lucky I am alive. I even cut myself which I had no history of. My point …. DO YOUR OWN RESEARCH !! Dont even trust your pharmacy, doctor or nurse!! In research it clearly states not to mix with certain anti depressants and be careful with people with a history of depression…. No one caught this even tho they had my medical history!!! At least you would know what to look for.
I have been taking Provigil since 2005 and it has saved my life. I too would be in bed or in the chair all day. I take care of my parents plus my family and I need this medication for everyday life.
I have NO side effects, go to bed at 8pm every night. My insurance has now denied this very expensive drug (which it is in the “formulary”) and suggest to my Doctor I take Adderall, an Amphetamine instead. Provil is not an amphetamine. I tried samples of the NEW Nuvigil and I took half at 6am and was awake till 3am the next day. This stuff was wicked! Provil goes generic 2012 so now it the new Nuvigil instead they will market. I will be lost and very tired and probably very sick with fatigued without this medication. It make me mad when an insurance co. can tell a Doctor what to prescribe (even when the Doctor sent a “letter of necessity”)for the medication.
Terri I am having the same problem with my insurance co. Did you use an on-line pharmacy ? If so could you let me know.
Thanks Doug
Have you tried breaking the Nuvigil’s in half. I was suggested to cut Provigil in half (200mg) because, I was unable to sleep at nite. Just a thought.
skyler
Living with MS……
Without Provigil, I couldn’t make it through the day. For me, it’s been a life-saver. I’m able to work ~ 6 hours a day because of Provigil. Unfortunately, it is very expensive, but a must have for me.
I had been prescribed Provigil for excessive fatigue from FMS/CFS in 2005. I was literally falling asleep everywhere. This med has been a miracle. The low dose of 100mg daily gives me a feeling of having refreshed sleep. Last year my insurance would no longer cover it unless I met an official FDA approved diagnosis. I went to a neurologist who performed a sleep study and provided me with a diagnosis of SWSD from the 20 years I had worked nights but my insurance countered that this was the one FDA diagnosis they didn’t cover! My appeals were in vain. Cephalon gave out coupons for 30 days of Nuvigil. I only needed to take it for a week to see it doesn’t compare. Cephalon also stopped providing Doctors with samples of Provigil and have driven it’s cost up to such an exorbitant figure that other insurance companies won’t cover it. Since the generic of Provigil will be available in 2012 this is absolute pure greed on the part of this large pharmaceutical company. The tactic is to shamelessly force people to use Nuvigl. My doctors and I have discussed this and many articles can be found to substantiate this. Go and read. Nicely dressed big pharma reps toting nice lunches and prizes for the docs stroll past those of us in waiting rooms struggling to pay for meds. That’s sad enough but tactics like this by Cephalon is reprehensible.
I have taken generic brand of provigil (called modalert) which I bought from India. It appears to have given me a minor rash on my forearms. I’ve taken it for a couple months and only now it has manifested. I assume this is from the modalert since I have never had a rash in my entire life.. I’m going to stop taking it because the thought of Stevens Johnsons is terrifying to me.
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My insurance too will discontinue coverage of Provigil. Provigil is my life saver. My insurance company suggested Nuvigil as a replacement. After doing research, I am not willing to take it because of the potential side effects. I think it too is a problem when insurance companies have the ability to choose medications or substitutes for Doctors. I understand Provigil is costly, but it does its job. Has anyone had success with other anti fatigue medications?
I am trying Modavigil (Modafinil) and it works really well but i’ts expensive.
Although I must admit that provigil did its job by helping me stay awake, I must say that you should really read about the drug before taking it. Definitely don’t mix provigil and grapefruit juice. Nobody says why but I’ve experienced it, and it was horrible. I had chest pains, left arm pain, and my heart began to speed. I felt that I was having a panic attack. It continued for hours until the next morning.