As in other contexts, FDA’s salvation will also depend on people there with more guts than average to speak out about how things actually “go down.”

Dan Troy has trained FDA well,..Pretty spooky.

It is almost like the current FDA regime is petitioning itself.

What puzzles me a bit is the role of the NCL, not that I know anything about them. Certainly, if one _were_ (note hypothetical) trying to advance a position that was not solely about consumers, they would be a good wooden horse to hide inside. (To use a Troy metaphor.)

Re: Quibbler’s quibble, it raises the question for me of whether OTC inserts are governed by different labeling requirements. Does anyone know?

http://www.pharmalot.com/2007/10/fda-diluted-antidepressant-med-guide-us-rep/

Pharmalot has covered the Med Guide issue
http://www.pharmalot.com/2008/02/congressman-wants-probe-into-med-guides/
This issue was a hot item during the PDUFA Hearings. I would be more than happy to provide you with Pharma, Congressional,. FDA Chain Drug Stores, documents that are a part of a Congressional Investigation.

This Petition is a joke, and should not be taken seriously!!!

Check this out
http://www.pharmalot.com/2007/06/in-nj-a-fight-over-black-box-warnings/

Perhaps it’s a quibble, but the insert you link to is for prescription strength naproxen, not Aleve.

In my brief search I didn’t find a full package insert for Aleve, but the warning info on the Aleve website is much less extensive than on the Rx insert you link to.

http://www.aleve.com/tablets.html

I have related that I personally had an AE with a med that wasn’t listed anywhere on its label (and still isn’t). But it has been the subject of a case report article (not just my own case) in the Archives of Opthamology, with comment that there is a high likelihood that it was, indeed, caused by the med. (Occurred and disappeared through three retrials.)

Had that information been on the PI - for both myself and my doc - I would have both felt less “crazy” and unnecessary additional testing and consults would probably have been avoided.

So I guess I can’t agree with the idea of “too much” information if at least physicians know how to use it. OTC becomes the responsibility of the rest of us, but I’m still unclear that having less is more useful and more is not. The throw-away that “this is just to shield lawyers”, or some other CYA purpose, does a disservice to pts who might actually find their own experience listed, and, in consultation with their docs, make more informed choices about what the next best steps may be.

http://www.fda.gov/cder/foi/label/2004/17581s99,100,18164s50,51,18965s9,10,20067s4,6lbl.pdf

Look at the list of side effects. Dozens and dozens and dozens. I would estimate well over 150 side effects lists – many very very serious. **This is a laundry list.** Why is it this way? This is an OTC pain medication commonly believed to be much safer than Vioxx. Based on reading this information would you really believe that this is safer than Vioxx? How is a consumer (or doctor) supposed to learn anything from this information? This is just a information overload and an example of the system gone amuck. Do you disagree?