FDA warns about 'stay awake drug' Pro...

FDA warns about 'stay awake drug' Provigil

There are 53 comments on the Medical News story from Oct 28, 2007, titled FDA warns about 'stay awake drug' Provigil. In it, Medical News reports that:

The U.S. Food and Drug Administration has issued a warning in connection with the drug Provigil because of dangerous side effects. via Medical News

Join the discussion below, or Read more at Medical News.

Rick

Fishers, IN

#21 Feb 11, 2009
I have had similar positive effects from taking Provigil for the last 1 1/2 years. I had a 45 minute drive to work and many mornings I couldn't make it without stopping for a nap. And getting excess rest and sleep during vacation and weekends didn't help. I did a sleep study that determined I was a borderline narcoleptic.
I started taking 200 mg in the morning and the results have been great. I also take 1/2 tablet (with the doctor's ok) sometimes in the afternoon if I need to be alert for something later in the day.
It has also helped with feelings of depression although I haven't been diagnosed with this.
I hope to see an endocrinologist to better understand the root cause of the sleepiness.
Cost has been rising and I just lost my job and insurance benefits. Provigil is something I will have to continue to use to maintain my quality of life.
ziggy

Medford, OR

#22 Mar 17, 2009
Dyscrasy wrote:
I can't LIVE without the stuff. It's SO expensive I buy it from overseas pharmacies, until it hopefully goes generic in the states. The only side effect i've ever had is, when I first started using it, I'd get a little cranky when "coming off of it". I have chronic fatigue (not the syndrome, just perpetual tiredness) so it's a necessity for me. I've turned a couple friends on to it, one's a pilot, the others a hypothyroid sufferer, and my sisters. Everyone loves it. Where I buy it (overseas) no prescription is needed.(That's the way it should be here as well) A LOT of drugs have some side effects. A fool drinking 10 bottles of cough syrup might get high, an idiot swallowing 25 Benadryl and a bottle of Excedrin might die. A couple people having hallucinations is no reason to pull a drug from the REST of us who LOVE it! I'd make a good salesperson for Provigil because I love it so. I don't know what I'd do if they pull it... Have to resort to Meth? Speed? Cocaine? Heroin? Yikes...
Can you tell me where one can obtain this med? I had it after a brain injury and it worked wonders, but was costing too much money. I also have to contend with chronic fatigue and acute chronic hypothyroidism. Can't find a doctor now who will prescribe. Is that because the FDA won't approve this drug after all? Please help, I'd like to get out of bed before I die!
Bruce Alan

Sacramento, CA

#23 Mar 26, 2009
Mike, quoted below, is almost certainly a Cephalon employee. Cephalon is the manufacturer of Provigil and also Nuvigil, the same drug under a different name. In 2006, Cephalon sought approval from the FDA to begin marketing Provigil for the treatment of ADHD ? ADD ( attention deficit disorder ) and yet another phony name, SPARLON. The FDA committee which examined the safety of Provigil / Sparlon /Nuvigil determined that mortally dangerous reactions take place 400 times more often with Provigil . The FDA turned down the petition to sell Provigil for ADHD because it was believed by the commitee on a 13 to 1 vote that Provigil was just too dangerous to have so man more people taking it.
Mike wrote:
Quick Google searching: in 2004 1.9 million prescriptions for Provigil were written in the US amounting to $414 million in sales. In 2005 prescritions for Provigil totaled $512 million.( Forbes.com on 3/13/06). How many individual patients this represents I do not know. Although the quantity has probably increased each year if at least 2 million prescriptions have been written annually since 2004 how many cases of skin rashes, hallucinations, or suicidal tendencies make up a warning from the FDA as opposed to yanking FDA approval?
I think a lot of people have a problem comprehending what large numbers represent. They can create a picture in their mind of things in smaller quantities. When they need to relate that to something beyond a certain size they seem to convert the larger quantity into some ambiguous abstraction. This results in the smaller quantity having more power and influence because the larger power is not clearly acknowledged.
A handful of people out of millions have a few adverse reactions. Even if a few die is that really significant? The greater the number of people using it the greater the chance is that someone somewhere will have a different reaction to it.
Modafinil is relatively harmless. If you hallucinate or feel like killing yourself you probably have serious problems. Modafinil wakes up neurotics and geniuses. It doesn't make you either.
Joakim Hansson

San Fernando, CA

#24 Apr 6, 2009
Provigil litterally saved my life. NO SIDE EFFECTS (except insomnia, sure it is indeed a pill for narcholepsy so that make sense..), but that fortunately goes away after a while. I also wanna add that it sure helped my depression. No sucidal thoughts nor any fuckitol thoughts... I consider it 2 b Gods gift.
way2sleepy

Buffalo, NY

#25 May 30, 2009
I started on Provigil 3 weeks ago. At 200mg I was still feeling tired by the end of my work day and dozing while driving home. I was increased to 300mg last week and not finding much difference in the afternoon. My Dr. said it is a once a day medication and did not give me the option of taking the 300mg in divided doses. I have tried that anyway, but then I am not as alert during the day. Any suggestions? He did say he will titrate my dosage, and will prescribe 400mg since this is the maximum daily allowance.

I take Provigil for recent diagnosis of narcolepsy, without cataplexy, after a sleep study as well as an MSLT. Sleep latency over 5 naps averaged 1.2 minutes. The fifth nap I was sleeping before the tech got to the observation room 3 doors down. Anyone else have the MSLT? that test was pure torture for me!

Would appreciate any advice from those with more experience with Provigil than myself. I do not know anyone else who takes it to ask for advice. Thank you!
Bright Eyed Bushy Tailed

UK

#26 Oct 24, 2009
its weird. if it was such a big problem they would have recalled it. anyway I have always found this company to be good. Never had a problem.

http://www.the-clap.com/provigil.htm
Clear Windshield Effect

Maryville, TN

#27 Nov 11, 2009
my doctor prescribed time release amphetamines. even in the smallest dose it was too much. definitely not my type of chemical. yes i know of people who grind up several of them and seem to like it. my deal was a low level ADHD or ADD. the provigil actually did the right trick, but at low dosage, 100mg/day, taken right before the afternoon siesta urge, or around 5pm so the evening remained productive.
Mindie Thomas

AOL

#28 Nov 21, 2009
When my Dr was telling me about Provigil he said that they approved it one day for ADHD and that afternoon a child developed Steven Johnson Syndrom and they pulled it that next morning. I take 200 first thing in the morning and then 200 at noon to help me the rest of the day. I had the horrid headaches, but that seems to have faded. I do feel a bit of a perky feeling and a bit up, but it's so much better then yawning all day and having to force myself to keep busy so I don't fall asleep on the couch. Our insurance went up so I pay $60 a month, however my perscription is over $700 a month, so I don't complain offten. I have lost weight on it but I've not had any of the other side-effects. I'm Bi-polar II with excessive sleepiness and for years we tried to control it by making me sleep at night. Finally we decided to try and keep me away. It's worked great so far.
Bruce Alan wrote:
Mike, quoted below, is almost certainly a Cephalon employee. Cephalon is the manufacturer of Provigil and also Nuvigil, the same drug under a different name. In 2006, Cephalon sought approval from the FDA to begin marketing Provigil for the treatment of ADHD ? ADD ( attention deficit disorder ) and yet another phony name, SPARLON. The FDA committee which examined the safety of Provigil / Sparlon /Nuvigil determined that mortally dangerous reactions take place 400 times more often with Provigil . The FDA turned down the petition to sell Provigil for ADHD because it was believed by the commitee on a 13 to 1 vote that Provigil was just too dangerous to have so man more people taking it.
<quoted text>
Gersey

Irving, TX

#29 Nov 26, 2009
I have been taking Provigil for 5 years for brain fog I suffer for being on a heart/lung machine for over nine hours during aortic valve replacement surgery. On Jan 1, my copay is going up to over $500.00 for a 30 day supply,so I can no longer afford it. What can I do? There is no generic until 2011. What are the legalities of ordering generic Modafinil over the internet?
jedd30

Alpena, MI

#30 Dec 3, 2009
I cant believe all of this is true!! You know, when I was young and first started experimenting with drugs, I thought "some day, there will be a drug developed that doesn't have any side effects, and withdrawal symptoms". I have used cocaine and methampthtamine and they are way too harsh, and illegal. So now, here it is. Provigli. I am getting the script tomorrow and I am so excited!! I have been falling asleep or feeling sleepy so much lately. I'm getting my MBA/JD now and its very demanding after being out of school for 10 years now. I'm also a recovering alcoholic, so I can't takre any of the class II drugs, nor do I want to. Thank you Cephalon!! And no, I'm not a worker of Cephalon. If they have this to the public now, I wonder what drugs they have that are sectret stuff, for he military. Our society is constatntly asking for higher peformance, pushing out bodies and brains to the absolut limits, without proper nutrrition,so in the long run we burn out. I execise regularly and I'm in great shape, but my brain is constantly fried from school.
Tammy

Chickasha, OK

#32 Jan 4, 2010
Would you want to share your online source?? I have been paying over $400 a month for these and fairly new to it...only been diagnosed a year but it has changed my life! I can't find a pharmacy online that actually sells the real thing....THanks!!!
Dyscrasy wrote:
I can't LIVE without the stuff. It's SO expensive I buy it from overseas pharmacies, until it hopefully goes generic in the states. The only side effect i've ever had is, when I first started using it, I'd get a little cranky when "coming off of it". I have chronic fatigue (not the syndrome, just perpetual tiredness) so it's a necessity for me. I've turned a couple friends on to it, one's a pilot, the others a hypothyroid sufferer, and my sisters. Everyone loves it. Where I buy it (overseas) no prescription is needed.(That's the way it should be here as well) A LOT of drugs have some side effects. A fool drinking 10 bottles of cough syrup might get high, an idiot swallowing 25 Benadryl and a bottle of Excedrin might die. A couple people having hallucinations is no reason to pull a drug from the REST of us who LOVE it! I'd make a good salesperson for Provigil because I love it so. I don't know what I'd do if they pull it... Have to resort to Meth? Speed? Cocaine? Heroin? Yikes...
John

Scottsdale, AZ

#33 Jan 29, 2010
@ mkp: Here you go, they sold very cheap and I personally received the package very fast. http://provigilbuy.com
John

Scottsdale, AZ

#34 Jan 29, 2010
Oh yes, I am the one who can not live without this stuff too. The job requires me to stay awake and it definitely save my life T____T Can not imagine how my life is without it. Anyway, my last response is for mkp (bc I just read the 1st page) but also for anyone who is looking to buy this product cheap and receive fast. provigilbuy.com
Robbie

Murfreesboro, TN

#35 May 2, 2010
i need to know how you guys get this provilgil.i stay sleepy allthr time.i have fibromyalig and chronic fatigue.my ins will not pay for this.i need it so bad.please help......
Meshi

Belle, WV

#37 Jun 14, 2010
I have been taking Provigil for about three years now, I have been diagnosed with Fibromyalgia, Chronic Fatigue, and Narcolepsy...before Provigil my life was awful. I was falling asleep at work, while driving, and many day I could not wake up at all...Provigil has given me my life back. I understand the concerns about the high cost, I lost my insurance benefits and was scared I was not going to have my meds, if you go to www.provogil.com you will find that Cephalon has an assistance program, after sending a letter from my MD and a copy of my financial info I received my meds directly from Cephalon, the assistance varies depending upon your personal finances but I would not have made it without this.
Mindie Thomas

United States

#40 Jul 28, 2010
Well, so much for having wonderfully wakeful days. Provigil was a true God send and at the end of June I got a letter from insurance saying Provigil would no longer be covered but that I could take Nuvigil. Dr gave me 250 of Nuvigil and it did nothing. When he tried to increase my dose insurance refused saying they would only pay for one pill a day. Then out of the blue I get a call from the pharamacy and it's been approved. Seems Provigil will soon be generic and rather than lose business nuvigil dropped their price so insurances cover more. That would be wonderful if Nuvgil worked all the time... I miss my provigil. :(
BruceAlan

El Dorado Hills, CA

#47 Oct 10, 2010
I'm a little biased about Provigil inasmuch as a side effect which occurs in ONE out of every FIFTY users by Cephalon's own report, VASODILITATION, got out of hand, sent me into distributive shock, caused my heart to fail and otherwise all but killed me.
Now the brain fog which sent me to it originally is more like a white-out since when I went into shock I suffered pervasive hypoxic brain damage.

Before anyone uses Provigil or Nuvigil they should try taking 2 daily doses of 400mg of caffeine in pill form. The effects are superior, something I knew when I was taking Provigil.
Furthermore, very recent medical results show no negative cardiac effect from this daily dose of caffeine.(Don't do it with coffee, which is laden with other psychoactive substances and can cause cardiac problems).
BruceAlan

El Dorado Hills, CA

#52 Oct 19, 2010
Mike wrote:
Quick Google searching: in 2004 1.9 million prescriptions for Provigil were written in the US amounting to $414 million in sales. In 2005 prescritions for Provigil totaled $512 million.( Forbes.com on 3/13/06). How many individual patients this represents I do not know. Although the quantity has probably increased each year if at least 2 million prescriptions have been written annually since 2004 how many cases of skin rashes, hallucinations, or suicidal tendencies make up a warning from the FDA as opposed to yanking FDA approval?
I think a lot of people have a problem comprehending what large numbers represent. They can create a picture in their mind of things in smaller quantities. When they need to relate that to something beyond a certain size they seem to convert the larger quantity into some ambiguous abstraction. This results in the smaller quantity having more power and influence because the larger power is not clearly acknowledged.
A handful of people out of millions have a few adverse reactions. Even if a few die is that really significant? The greater the number of people using it the greater the chance is that someone somewhere will have a different reaction to it.
Modafinil is relatively harmless. If you hallucinate or feel like killing yourself you probably have serious problems. Modafinil wakes up neurotics and geniuses. It doesn't make you either.
The number is 1 out of every 200, according to Cephalon's own count in subsequent testing.
BruceAlan

El Dorado Hills, CA

#53 Oct 19, 2010
1 out of 200 = 10,000 seriously ill people out of 2 million users - not a small number for such a serious condition. Additionally Cephalon's testing also showed that 1 out of every 50 users were affected by vasodilitation. Also called vasodilation it is the cause of hypotension, which in people with occult coronary artery disease can put them into cardiogenic shock, a deadly condition which kills 60-85% of patients depending upon the treating facility
Jerry

United States

#56 Nov 15, 2010
I can get generic Provigil (Modafinil) for a very good price, and it's Spier Modafinil every time so I know it's going to be a quality medication.

Please remember, before you buy any prescription medication ANYWHERE, talk to your family physician first then shop around.

My pharmacy might not have the lowest price for Modafinil, but I trust them, and that counts for a lot in my book.

Visit us at:

Why I Buy Modafinil Online

http://modafinilonline.us

You will be glad you did.

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