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Author Topic: FDA *first* online list of drugs under investigation for safety problems  (Read 4711 times)

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Offline leit

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FDA *first* online list of drugs under investigation for safety problems
« on: September 14, 2008, 08:41:18 pm »

http://www.fda.gov/cder/aers/potential_signals/potential_signals_2008Q1.htm
Fortunately, nothing regarding us, EXCEPT ETRAVIRINE ("INTELENCE")!

« Last Edit: September 14, 2008, 11:24:26 pm by leit »
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Offline Miss Philicia

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Re: FDA *first* online list of drugs under investigation for safety problems
« Reply #1 on: September 14, 2008, 09:02:15 pm »
I see one new HIV med on there, unless I'm missing something. 
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Offline leit

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Re: FDA *first* online list of drugs under investigation for safety problems
« Reply #2 on: September 14, 2008, 11:27:58 pm »

Thanks! You're right and I amended my previous post. Mabye my mistake was due to the fact that I always considered TMC125/etravirine just better than a torture like Fuzeon.

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Offline Miss Philicia

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Re: FDA *first* online list of drugs under investigation for safety problems
« Reply #3 on: September 14, 2008, 11:52:10 pm »
Quote from: leit on September 14, 2008, 11:27:58 pm
Mabye my mistake was due to the fact that I always considered TMC125/etravirine just better than a torture like Fuzeon.



Why would you compare either a pill or even an injectable drug like "torture"?
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Offline leit

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Re: FDA *first* online list of drugs under investigation for safety problems
« Reply #4 on: September 15, 2008, 09:35:10 am »

Quote from: philly267 on September 14, 2008, 11:52:10 pm
Why would you compare [...] an injectable drug like "torture"?

Fuzeon is a PLEASURE! Is it ok, now?

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Offline Miss Philicia

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Re: FDA *first* online list of drugs under investigation for safety problems
« Reply #5 on: September 15, 2008, 01:38:41 pm »
Quote from: leit on September 15, 2008, 09:35:10 am
Fuzeon is a PLEASURE! Is it ok, now?



Now you're just being silly.  Have you actually had to take Fuzeon?  I have.  If a medication that was the first one to suppress my viral load after 13 years is "torture" I don't know what to say.

Is it a pain in the ass at times?  Sure, but torture?  No.  Remind me what your personal experience is in terms of what HIV medication you have taken or are currently taking.

And I'm still not clear on why you considered TMC125/etravirine as something difficult to take.  Care to clarify your comment?
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Offline Tim Horn

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Re: FDA *first* online list of drugs under investigation for safety problems
« Reply #6 on: September 15, 2008, 02:14:01 pm »
As for the etravirine listing, it involves one patient who developed hemarthrosis -- bleeding into a joint -- while on etravirine. It's worth noting that the patient also had thrombocytopenia -- a low platelet count -- which should certainly be eyed as the primary culprit.

I, and a few others, have been in contact with the FDA regarding these new reports from the FDA's Adverse Event Reporting System, as they are terribly vague and completely without context.

Tim Horn
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Offline Miss Philicia

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Re: FDA *first* online list of drugs under investigation for safety problems
« Reply #7 on: September 15, 2008, 02:17:35 pm »
Thanks Tim.  Yeah, I did a bit of googling after this thread went up and really couldn't find any information supporting this listing.  And after your post it amazes me that anything would be put on a list like this because of one patient.  How alarmist can you be?
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