![[dr. bob]](/dr-bob-sm.gif)
Dr. Bob is Robert Hsiung, MD,
bob@dr-bob.orgShown: posts 1 to 4 of 4. This is the beginning of the thread.
Posted by Elayne on March 20, 2002, at 10:24:58
Hi everyone,
This is a response to a specific question from a few days ago, but I seem to have lost that thread.Anyway, the FDA required Serzone to add a "black box" warning to its info to prescribers because of an observed incidence of 1 case of liver failure per 250,000 to 300,000 patient years. This is about 3 to 4 times the rate of liver failure expected without the drug.
You might try to access this web site for the details: www.fda.gov./medwatch/SAFETY/2002/serzone_deardoc.PDF.
Hope this helps.
Elayne
Posted by beardedlady on March 20, 2002, at 10:32:52
In reply to Serzone concerns, posted by Elayne on March 20, 2002, at 10:24:58
Thanks, Elayne. But that link seems to have expired. I still don't know what "patient years" works out to be. Since I've been on three years, do I have a one in 83,000 shot? Or if everyone's been on, say, 10 years, do we each have 10 chances in 25,000—or one chance in 2,500? Anybody understand this convoluted way of saying how many people can get it? And what other risk factors are involved? Maybe that web site might have said.
beardy : )>
Posted by Elayne on March 20, 2002, at 11:58:35
In reply to Re: Serzone concerns, posted by beardedlady on March 20, 2002, at 10:32:52
> Thanks, Elayne. But that link seems to have expired.
Really? I looked at it today. Try going to the www.fda.gov/medwatch site and see if you can get to Serzone from there.
(I still don't know what "patient years" works out to be.)
"Patient years" is a sum of individual experiences with the drug.
Person A: 10 years
Person B: 5 years
Person C: 1 year
Person D: 4 years
Total: 20 Patient years, but only 4 people!(Since I've been on three years, do I have a one in 83,000 shot? Or if everyone's been on, say, 10 years, do we each have 10 chances in 25,000—or one chance in 2,500?)
Yes and no. Mathematically, you could say your risk is between 1 in 83,000 and 1 in 100,000 based on years of exposure. But actually, it's more likely that your personal risk is much, much lower because if you were going to have a problem it would have shown up early on.
(Anybody understand this convoluted way of saying how many people can get it? )
(And what other risk factors are involved? Maybe that web site might have said.)Underlying liver disease. Previous liver toxicity on Serzone. Elevated levels of liver enzymes on a blood test (AST or ALT).
>
> beardy : )>So -- does this make sense? Also, I hope I haven't done this twice since I goofed up trying to submit this a few minutes ago. Sorry.
Elayne
Posted by beardedlady on March 20, 2002, at 13:38:22
In reply to Re: Serzone concerns, posted by Elayne on March 20, 2002, at 11:58:35
This is the end of the thread.
Psycho-Babble Medication | Extras | FAQ
Dr. Bob is Robert Hsiung, MD,
bob@dr-bob.org
Script revised: February 4, 2008
URL: http://www.dr-bob.org/cgi-bin/pb/mget.pl
Copyright 2006-17 Robert Hsiung.
Owned and operated by Dr. Bob LLC and not the University of Chicago.