Provigil Warning!!!
Wednesday October 31, 2007
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.