Pitting the FDA

I heard a new medication today called Nuvigil. It is now being prescribed for Shift Differential syndrome. The inability to stay awake because you have a split shift.

The goal here is being alert

Side effects

Dry mouth
Indigestion or heartburn
Upper abdominal pain
Loose stools
Flu-like symptoms (such as fever and chills)
Loss of appetite
Shakiness (tremor)
Unusual sensations, such as numbness or tingling
Increased urination
Increased sweating
Chest pain, high blood pressure (hypertension), or a rapid heart rate (tachycardia)
Feelings of a rapidly or forcefully beating heart (known as heart palpitations)
Anxiety, depression, confusion, hallucinations, or any other emotional or psychological changes (including suicide)
Feeling like you need to increase your dose or take it more frequently (as this may be a sign of abuse or dependence)
Signs of an allergic reaction, such as a rash, hives, itching, swelling of the mouth or throat, wheezing, or difficulty breathing.

Like many other medications, Nuvigil can cause a rare, extremely dangerous side effect called Stevens-Johnson syndrome (SJS). This problem starts out as a rash, but it can soon become life-threatening, sometimes resulting in the loss of large segments of skin (which can lead to disfigurement or even death). Therefore, tell your healthcare provider immediately if you develop an unexplained rash while taking the drug. In almost all cases, Nuvigil should be stopped, since it is impossible to tell if any particular rash will become dangerous. If you cannot reach your healthcare provider immediately, you should stop taking Nuvigil until you receive further instructions.

All this, so you can work your shift.

It seems as long as you say, we will cure ya with death, it is legal and profitable. Shouldnt the FDA be protecting us from this crap? Let me emphasize, this isnt a recent issue. This has crossed administrations and political parties for years.

It looks like FDA is short for Fucking Dead Asswipes

Interesting, a drug to keep you awake that has a side effect of fatigue?

It’s because of the FDA that you know of these potential side effects. They’re not making you take the drug. In fact, no one is making you take it.

If I’m not mistaken, if ANY side effect is reported by a subject during trials, the manufacturer is required to report that to the FDA and list it as a potential side effect. Even if it may not be directly connected to the medication.

They are required to put on there any side effect that was reported. Basically every drug has that same list of side effects. It doesn’t mean will you get them all. Most people won’t get any.

Sounds to me like the FDA is doing its job, if only perhaps too well. Or would you prefer the good old days where medicine sellers weren’t required to list that stuff?

Or do you think there is a magic world where medicines don’t have side effects at all?

Look at the side effects of aspirin some time.

I work in medical research in ophthalmology - in a clinic/hospital, not for the pharma companies. We do report every single side effect and question the study subjects at each visit about any kind of health complaint they might have. I have dutifully reported colds, seasonal allergies, prostate problems, headaches, nausea (caused by a bus ride and sitting next to someone with too much cologne), all kinds of things. I have reported deaths due to complications from AIDS, heart attack, and murder. We also rate the likelihood that a side effect was related to the medication, and typically the listed side effects are those that occurred more often in the medication group than the placebo group - because even placebos can cause side effects!

That being said, take a look at the full list of potential side effects for every single medication you take, including over-the-counter drugs. Tylenol has a decent risk of causing liver damage or failure if you take too much, especially if you are drinking alcohol. I have personally taken a medication for a couple decades that increases risk of blood clots and stroke. Start reading too many side-effect lists and you may not want to take anything again - until you encounter a risk of not taking a medication!

Im a former paramedic. Im aware on some level of pharmacology.

Im also aware of common side effects such as nausea etc. Anaphylaxis is not uncommon either and varies in level.

It just seems it is getting worse to me with newer meds.

Is it? Or are you just responding to the reporting requirements now?

FDA procedure hasn’t really changed much over the past couple of decades.

I may or may not notice something that may or may not be happening! This may or may not be because the FDA may or may not be doing (or not doing) something!

I may or may not pit it!

How frequently does a given side effect have to occur to warrant reporting?

There’s not really a cut-and-dried number. Frequency is an issue, of course, but so is the likelihood that a given side effect is actually related to the study drug rather than to the disease or another medication. Also, very severe effects are very likely to be reported whether they are common or rare. You give the FDA all of your data; they tell you what the labeling requirements will be. And they, understandably, tend to err on the side of caution.

Thanks. So it’s possible (though unlikely) that fatigue or whatever will be a label requirement because one guy in the test group was tired?

Was September 2011 really a couple of decades ago? How time flies.

See, this could have been a perfectly good GQ thread.

Dude-drugs have side effects, many, if not most, will never be experienced by the patient. But all side effects that have been noted must be included in the drug literature. Take Topamax, for example. A common epilepsy drug with page after page of possible side-effects.

Possible and very likely. The full FDA labels for a drug include the data on side effects. For example, here’s the label for Nuvagil (big-ass PDF warning), on page 27 there’s side effect information.

Headaches: Reported in 17/645 test subjects on Nuvagil (vs 9/445 on placebo)
Nausea: 7 (vs 3)
Dry mouth: 4 (vs 1)
Insomnia: 5 (vs 1)
Dizziness: 5 (vs 2)
which are probably real, though hardly common side effects.

Then if you keep going down the list, there are examples of one guy who reported something that probably has nothing to do with the drug. One subject was constipated, so it goes on the list of side effects. Same with flu-like symptoms, nervousness, and a whole host of others.

IMO the FDA is erring too far on the side of caution when they include every possible reported side effect. It’s understandable with serious side effects – if one out of a thousand subjects died during a test, it could be nothing, or it could mean that hundreds of people will die when the drug hits the market. Which happened recently, with an arthritis drug that caused serious cardiovascular side effects. Thus, the recent change in side effect reporting by the FDA.

But with minor side effects, that huge list of everyday minor complaints is just silly.

Provigil (roughly the same drug in a different form) isn’t too bad, except for the headaches when starting and stopping, the irritability/anxiety during and especially after stopping, and the impulsive behavior while on it. I take it sometimes for narcolepsy, especially when my normal dietary controls fail.

The thing about the fatigue side effect is that there is a difference between being excessively sleepy and being fatigued. It can keep you awake without making you any less tired.

It’s a massive case of CYA syndrome. If, say, one person is taking the drug and dies of, I don’t know, dizziness that causes him to fall off his roof, and the lawyers go back and see that one test subject reported dizziness and the FDA didn’t require it to be reported, then cha-CHING! The FDA will be sued to oblivion. No one wants to be the guy that stands up and says “we really don’t need to be reporting this minor stuff”, because then they’re on the hook for the first lawsuit to come along.

This is probably accurate. Increased information age probably makes it seem worse then it is.

It kind of reminds me of the Foxworthy Skit about anal seepage