Cool!

So why is it that when I type in "natalizumab" a seperate database comes up :

http://www.fdable.com/search/aers/ad...y/2fcb1d403a66

Also, do you know why reports for Avonex, Betaseron, etc. all pop up in the database when I request only Tysabri?

http://www.fdable.com/search/aers/ad...y/9eb4fec4b9b6

So, curiousity got the cat . . . why are you responsible for updating the FDAble AERS then? Moonlighting?

So are all cases of PML that are reported through AE SENT for independant confirmation then?

It would seem to me that people reporting PML cases shouldn't be doing so willy nilly. They must have some convincing evidence to venture such a "guess". . .

You might remember when the Crohn's patient died from what was reported as some other condition, and eventually his cause of death was re-evaluated. Not sure how they did this , but they determined in the end that it was PML. That was before the days when they "looked" for PML, of course, but clearly the dx isn't cut and dry even now.

Do you have any idea what happens when a AE reported PML case is "suspected"? Are all of these cases flagged and sent for independant analysis, or ?

That reminds me, TOUCH is only in the US and about 1/3 (I think) of the patients currently on Tysabri are from outside the US.

Is the AE system only for US reporting too, or does it include all countries?

Yes, I guess it would the the "risk minimization system", but I've not been able to find anything that describes the established procedures for reporting through that system.


Yeah, I just thought it was interesting to see a government site hook up to Wiki, but that's cool.

Do you have MS too?

You've been a big help, thanks!

Cherie