Silver Spring, MDA drug that can potentially fight jet lag has been linked to some rare, life-threatening skin rashes such as Stevens-Johnson Syndrome, NPR reports.
Nuvigil, which is manufactured by drugmaker Cephalon, reportedly carries a significant warning about the risk of developing the condition, the news provider said.
Additionally, the FDA recently rejected the drug company's efforts to market the medicine as a jet lag fighter. The drug is already approved for fighting fatigue related to shift work as well as narcolepsy, according to the news source.
In March, the FDA questioned the strength of the data supporting the drug's use in fighting symptoms of jet lag. Though the company then gave more information to the agency, Cephalon said that the new data was not enough.
"[T]he company believes that further communications with the FDA will not result in an approval of this application," said Dr. Lesley Russell, Cephalon's chief medical officer. "As a result, the company is no longer pursuing this indication."
Some of the most common side effects of Nuvigil include headache, insomnia and nausea, according to the drugmaker.
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Hi,
I was given Nuvigil by a government Mental Health Agency. I was given samples for close to a year for chronic fatigue. I was told it WAS NOT addictive. Af first, I loved it. But, after a few months I would get sleepy just a few hours after taking it, and told my Med Review LPN, and she raised it to the maximum dose allowed. Still saying it was NON ADDICTIVE. Well, that raise helped me stay awake, but my mind has gone bananas. I can't get anything done. When the drug is working, I will start doing something, and when it wears off an hour or so later, I get tired and forget what I am doing. I have 25 unfinsihed projects at my house, I don't clean anymore as I get lost in something else unimportant. It has turned me into a itchy, scaley skin mess. My hair is falling out. I am so so tired all the time. I rarely leave the house. It has slowly destroyed my memory, and now the woman who started me on it has quit, and I now find out it IS addictive. I am a recovering addict, and feel like I, and a handful of others were used as guinea pigs for the drug maker and govt. without our knowledge. After I took the samples for a year, the LPN med review woman told me she had very few samples left, and I would have to go through a "sleep Study" to get a prescription, which I did. So, the first year I took them, I wasn't even supposed to be taking them as they were not approved for chronic fatique, but for sleep apnea, and you had to have a C-Pap machine to get the prescription which meant I had to go through the sleep study. Just so happened I had a mild case of sleep apnea, and was able to get the machine. I have since found out the cause of my fatigue is a hereditary form of anemia, hyperhomocysteineanemia, or something like that. I just call it homoanemia, as I have a gay brother and we make up silly names for stuff, and I was recently tested for Lupus. I shake, I am very forgetful. We find the canned dog food in the microwave instead of the refrigerator, I get lost mentally and can't remember important things from the day before, like what I had for dinner. My brother will tell me about something, and an hour later I can't rememeber what he told me. I'm still on 250 mg, as I am afraid now that I am addicted to it. I am a 50 year old disabled female. I cannot afford to go into a decent treatment center to detox from this awful drug, and am afraid if I don't I will develop Alzheimers or worse. God only knows what it is doing to my body. Any advice or similar story's??? Thankyou.
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Nuvigil, which is manufactured by drugmaker Cephalon, reportedly carries a significant warning about the risk of developing the condition, the news provider said.
