I participated in a drug study when Mirapex, a drug already approved for use in Parkinson’s Disease, was being studied for relabeling as a treatment for Restless Legs Syndrome. After my physical exam I was shown into a room with a HUGE notebook - easily 10 inches thick - which contained EVERY side effect ever reported for the drug. I looked through the first few pages - the most common side effects - and decided to go through with the study. The only side effect I noticed was unusually vivid dreams, which was one of the most common side effects reported.
If you need to take drugs to do your job, you probably need a different job.
Someone recently commented that if aspirin were introduced today, it would not get FDA approval.
Actually I suspect that most of those are probably not real. The probability of getting a difference as large as 5/645 versus 2/445 by chance alone is 40%, Based on my reading of the labels of medications it appears to me that they report any side effect that occurred more frequently in the test subjects than in the placebo, regardless of statistical significance. Better safe than sorry.
Pretty funny.
Many drugs will have the opposite of their intended effect as a reported side effect. Whatever the bodily process is that’s being tinkered with, some people will react in the other direction.
As a scientist at a pharmaceutical company, if my neighbor tells me that he knows a guy who died in a car crash, and mentions that that guy was on our drug (even if it is a drug for asthma, or something I can’t imagine has anything to do with the car crash) I’m instructed, under no uncertain terms, that I must report this to the company and that they will report it to the FDA.
Despite the idea that companies and the FDA play fast and loose, we take these things pretty seriously.
It’s hardly a new drug. According to its Wikipedia page
It’s also just a “purer” form of the even older drug modafanil (Provigil), which has been available in the US since 1998 and the UK since 2002.
Now that we’re clear on that, carry on with your hysteria. I’d join in, but my Nuvigil is making me too sleepy.
LOL@Hysteria. BWAAAAAAA NEW DRUGS!
By the way, since you linked wiki, you might want to read it to find out what it does.
I know what it does, you moron. I’ve been taking your scary “new” medication for years.
I’m getting the drug just for the side effects! 
Side effects may include headache, nausea, and getting stabbed in the face.
It looks to me like you’ve misinterpreted the chart. It’s saying headaches were reported in 17 PERCENT of the 645 test subjects, and so on for the rest. (Specifically, on page 29, we are told that headaches were reported in 23% of the 198 subjects who received 250 mg, and in 14% of the 447 subjects who received 150 mg, for a combined 17% of 645 subjects. I think we can agree that these are significant percentages. And every mentioned incident occurred with frequency at least 1% greater (in absolute terms) among medicine-takers than placebo-takers.)
I’ve taken the stuff because of daytime sleepiness due to sleep apnea, and I love it. Expensive as fuck though, a month’s supply, even with insurance paying for some of it, was around $300. I’m not taking it regularly because of that. But it works perfectly for me, no side effects, and I feel very wakeful and alert.
The predecessor, provigil, is supposed to have generic versions at some point, I thought.
My mistake. I suppose that would make some of those side effects fairly common, particularly headaches.
But those 1% (vs 0% placebo) side effects are entirely in the range of statistical noise, and 1% is itself a pretty arbitrary cutoff.
Yes, I agree with that. It’s just not quite as bad as “If even a single patient reports it, it goes in”.