FDA AERS /FDAble site
 

As per a posting by RW several months ago (thanks), I've been able to go on the FDAble site to check adverse reactions reported on drugs:

. . . but when I tried today, I received a new message saying:

"FDable is transitioning to an invitation-only mode. If you are interested in becoming a member, email us at administrator@fdable.com"

Is this something everyone is getting when they go to this site now, or is it only blocking Canadian access? (I've seen that happen before with sites ...)

Also, is anyone a member there now, and if so . . . what is the criteria for membership?

Cherie

I am getting the same message and I am in America.

No, I thought I'd ask here first, since sometimes this is just a "no CANADIANS allowed" thing. :p

Also, I know that RW used that site sometimes, and I was curious if she knew why it had become "invitation only", etc.

I'll probably try to sign up, and see what it says . . . Being Canadian and all, it might kick me out anyway. :D

Cherie

We had a big debate on one of the forums, because someone saw that they could buy cheap, generic Copaxone online at "Canadian Pharmacy" (or Canada Pharmacy ~ something like that). They figured we were scamming Teva by not following the US patent on the drug . . .

Every time any of the Canadians tried to access the site though, we'd get booted out . . . yet all the Americans were insisting they could get through and purchase the product. I guess the site had a block on Canadian IP addresses. :confused:

Turned out that "Canadian Pharmacy" was owned by an American, and operated out of California. :p

I can't watch a my favorite shows online either, like if I miss a Grey's Anatomy episode. Soon as it see's I'm Canadian, it boots me out. :(

.... so I always ask now. :D

http://i12.photobucket.com/albums/a2...adianmouse.gif
Cherie

Sorry Cherie, I just found this post while trying to catch up on the past few days.

The FDAble site is down for a big revamp. He may be going to a pay site, although he might allow limited free access. He's trying to figure that out right now.

He's suffered from some financial people exploiting the site and he put a huge amount of work into it and feels it's time for a change. I'll post more when I have more information.

FDAble/aers
 

Just as an FYI, the site is back up and is public.

-tba

I'm in the midst of adding Q32008 data from AERS which should be complete some time tomorrow.

Thanks so much tba!

Sounds like you are the person to ask questions of, if we don't know how to interpret some information posted there . . . ? :confused:

One thing that has always confused me is when there is one "Case#", with three or four "ISR#'s" assigned to the case.

Is the case# like an individualized "personnel" number for each client/patient, so that ANY time you get a report on a 'person', you source their previously assigned case#?

But when we look at the ISR'#s assigned to an individual case#, sometimes it "appears" that the exact same thing can be reported several times, sometimes on the same event date, but not necessarily. Does that just mean that the same event was reported that many times (from various sources?), or that these are seperate events?

An example would be in the following, under "Case#": 6553717:

http://www.fdable.com/search/aers/ad...y/b8031eda45cb

It shows two similar "ISR #'s" under that case# (person), but in different "Quarters" (one in Q1, and one in Q2), and with only one "Event date" documented .... How would we know if that is the same "event" remitted from two sources, or two seperate events that occurred? :confused:

A better example might be Case# 6551503 (on the same page). Are the four IRS's on that Case# (patient) the same events . . . and how could anyone know that by the report?

Also, where is the legend for the outcomes, like "DE" or "OT"?

Thanks!

Cherie

Hi lady_express_44,

regarding case # vs. ISR...your overall impression is correct.

But just in case you want more detail...think of it this way.

1. Imagine that you take a drug and suffer a HEART ATTACK and are HOSPITALIZED on March 1, 2008.

2. Because of this, you might file an INITIAL adverse event report to the FDA that says something along the lines of "I took Drug X and I had a heart attack and was hospitalized on March 1, 2008."

3. This INITIAL report gets both a Case # **and** an ISR.

4. NOW imagine that 2 days later you died of that heart attack.

5. your spouse or MD or attorney might submit a FOLLOWUP report saying, "and by the way...we had the initial outcome as HOSPITALIZATION, but there's a new outcome of DEATH as well."

6. This FOLLOWUP report (and any other followup reports) gets the same Case #, but it gets a separate ISR #.

So...this is my long-winded way of saying Case # ties together 1 or more reports for the same patient. Each report gets a separate ISR.

Hope that makes sense!

Is the case# like an individualized "personnel" number for each client/patient, so that ANY time you get a report on a 'person', you source their previously assigned case#?
YES!

But when we look at the ISR'#s assigned to an individual case#, sometimes it "appears" that the exact same thing can be reported several times, sometimes on the same event date, but not necessarily. Does that just mean that the same event was reported that many times (from various sources?), or that these are seperate events?

This is a good question, but the answer is not clear as there do not appear to be standardized methods for reporting adverse reactions. I **think** (emphasis on think) that most often, the adverse reactions that are repeated are actually duplications, but that is not necessarily always the case.

It shows two similar "ISR #'s" under that case# (person), but in different "Quarters" (one in Q1, and one in Q2), and with only one "Event date" documented .... How would we know if that is the same "event" remitted from two sources, or two seperate events that occurred? :confused:
Again, the answer isn't clear. In *some* cases, you can probably use common sense to figure out what's going on (e.g., if esophogeal cancer is listed in 2 separate ISRs from the same case, it's likely to simply be a duplication), but this isn't always the case.


Also, where is the legend for the outcomes, like "DE" or "OT"?
DE = Death
OT = Other (i.e. not death, hospitalization, congenital anomaly or "required intervention")
If you click on the column heading labeled "Outcomes", it will pop up a small window that gives you the legend.

Hope that helps.


Best,

-tba