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Old 01-22-2009, 12:46 PM #13
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lady_express_44 lady_express_44 is offline
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lady_express_44 lady_express_44 is offline
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lady_express_44's Avatar
 
Join Date: Aug 2006
Location: Vancouver, Canada
Posts: 3,300
15 yr Member
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Thanks, tba! I'll have a look at that.

Since you are updating Tysabri in particular, I wonder if you plan to be merging the Natalizumab and Tysabri data into one drug file? I understand that there may be several brand names for various drugs, sometimes made by different manufacturers, etc., but in the case of Tysabri/Natalizumab it is ONE drug, made by ONE manufacturer, so why not merge the data?

Do you work for the FDA, tba? If so, I have another question . . .

There are several drugs on the market that have the potential to cause serious risks (like Tysabri, Compath, etc.). In the FDA database, there are several "reports" of patients who "apparently" may have had i.e. PML, yet many of those cases have never been reported in the media/confirmed publically. I have "assumed" this means there was confirmation that that was NOT the cause then . . .

So . . . are all of the reported cases of "potential" PML cases reported on this site ultimately autopsied/100% screened out for PML? Is that the reason that those cases reported to the FDA were ultimately not "confirmed"?

Also, in the case of Tysabri, is there another formalized reporting method other than this site? I appreciate that this site takes "voluntary" reports, ie. it's up to the doctor/patient/family members to report (or not), but it's my understanding that the Tysabri Risk Plan established a seperate reporting method for adverse events . . . Or is this it?

Thanks again,

Cherie
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