FDA warns about 'stay awake drug' Provigil

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

[myersk0417]

Provigil has made my life so much better. I find it hard to believe that it could cause suicidial thoughts because it makes me feel happier than I do with out it.

[kyteflyer]

Might be a scare tactic to get people who don't really need it (ie lifestylers) to stop.

[Mike]

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.

[Not Sleepy Anymore]

Provigil has given me my life back. Don't let the fear of a rare side effect deter you from taking this medicine. Any medication has a risk of adverse effects. I have not noticed one unwanted effect from taking Provigil and I, like myersk0417, feel a million times happier now!

[David]

Google Answers put together an interesting analysis of the number of NDAs (new drug applications) that come into FDA each year, and the associated costs:

http://answers.google.com/answers/threadview...
FDA New Drug Applications

It gives some interesting perspective to a story like this.

[Mark]

I shall resist the massive temptation to make a dark joke here and just say that I've taken generic doses of Provigil lots of times and have never noticed any side effects. It's not exactly a wonder drug, but it helps enough. This FDA story sounds exaggerated to me.

[Dyscrasy]

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...

[whitefag to man in HK]

Before Modalert I was sort of living inside a dream. I always go out onto the streets and people laugh at me in my face and I scratched my head.(later I found out because I am too slim and too pale. But where I live every man is dark skinned and buff. This is the reality of Hong Kong don't believe movies.) So after Modalert I started "wake up to life" so to speak and join my local gym/tanning bed and get serious so I end up quite manly (and the whole time I take Modalert even now.).... Now as I go out on the streets the rest of men they don't dare to stare at me anymore because I am now like a cantonese-white monster to them. I love this stuff called Modafinil (or Modalert in my case.) I'm storming all over HK and it will be fun even if I end up in prison? Well, hope not ...

[Hii]

Hi I'm also from Hong Kong but I disagree with the message above. What I disagree is that Modalert doesn't turn one into a "Man". If you want to become a "Man" it takes hormonal therapy (including against plastic or estrogen of course)... maybe some Anabolic Steroids if you know how to inject them cleanly/properly/professionall y, etc. Hard work as well as dedication. And A-Men to that!

[saywhatboy]

Hong Kong Peeps ... errrr ... wa?

[saywhatboy]

Oh and re: the topic - been using modalert (cheapo version) for a couple of month now, on and off. Do feel my senses become somewehat dulled after a while and it aint so much fun, so take a break. Most research suggests it's benign. I Google obsessively when it comes to these things. Now steroids and sunbeds on the other hand ...

[Petit Merdeux]

He meant become more "manly", not actually become a man, like Anne Coulter.

[saywhatboy]

Who's Annie Coulter? And since when did using setroids mean "hard work"? For your liver, maybe ... Besides which, there's no look less manly than the orange tinted muscle mary ... rugby players with a bit of puppy fat, now there's a sexy, manly look. And, yeah, Modafinil.

[angel]

myersk0417 wrote:

Provigil has made my life so much better. I find it hard to believe that it could cause suicidial thoughts because it makes me feel happier than I do with out it.

I take 200mgs daily but did take 400 once and it made me feel weird and bad and at 400 mg daily it can cause psychosis. ANything over 400....who knows what that could cause. Even antidepressants can cause suicidal thoughts. These are mind altering drugs, it's hard telling how different people could be affected.

I take Provigil for Chronic Fatigue and it has changed my life....after 10 years of feeling horrible.

[HeD]

angel wrote:

<quoted text>
I take 200mgs daily but did take 400 once and it made me feel weird and bad and at 400 mg daily it can cause psychosis. ANything over 400....who knows what that could cause. Even antidepressants can cause suicidal thoughts. These are mind altering drugs, it's hard telling how different people could be affected.
I take Provigil for Chronic Fatigue and it has changed my life....after 10 years of feeling horrible.

I've been taking 600-800mg daily for 10 months now and feel great. I'm sure it's different for everyone, but we should probably not generalize and fear monger.

[Kelley]

I just started taking 200mg in the morning and afternoon. I am borderline Narcoleptic. I have CFS and FMS and Depression. After adding this to my new anti-depressant my life has finally begun at age 34. I started feeling bad after getting Mono the freshman year of highschool. This is a miracle for me. I am motivated, talkative, happy and not falling asleep everywhere. I also don't feel like I have the flu all the time. I do notice that I have to take a 5-7 day break from it once a month to keep myself from going into tolerance. I have been praying for a long time to have my life back. I did everything on my end like diet and exercise, but I never got the effect I needed. God gave me this medication and I thank him everyday for this medication because I feel alive in an alive world and not walking around feeling like I am walking dead. Email me about your experiences. [e-mail]

Right now our insurance pays for it free but after the first of the year that changes. I read above some get it overseas, could someone give me the website address to that?

God Bless you all

[Ann]

I have been on Adderall and fluxotine for depression for the past 4 years and this combo is no longer effective and I have developed high bp. I have been researching Provigil and think it might just do the trick. Right now my depression is keeping me from doing my job, wanting to get out of bed, experiencing joy in anything I do, having mild suicidal thoughts and no sex drive and hope for the future. I do not have insurance so need to buy a generic from a European online source. Does anyone have suggestions for tources?

[Debbie]

I have in the past taken a variey of anti depressants. Seems none has made any real difference. The most recent change was to discontinue the wellbrutrinXL and continue with the adderall and see if that helps.
I have read a few things about Provigil that sounds like it might be something worth looking into. I have been diagnosed with ADHD,which I was surprised to learn. For, all these years I have been treated for depression. Any helpful comments would be appreciated. It all feels like being on a roller coaster and not being able to get off

[ronald]

provigil isn't perfect, but has greatly improved my life, and i can stay awake for 5 to 8 hours stright through, for the first time in 47 years.Praise GOD & science. i have had no side affects what ever.

[mkp]

Where are some of you getting the generic? My med plan now wants me to pay $300 for a 20 day supply. THey will pay for Addarall but the side effects do scare me. Seems ridiculous that something that for me has had zero side effects and as others here have stated a huge difference in my life has to be replaced with a ritalin harsher alternative. Oh and you can only get a 30 day supply and sign forms everytime.

Help - where are the generics? Do I still need a perscrption?