From: sasghm@theseus.unx.sas.com (Gary Merrill)
Subject: Re: post-Prozac reactions
Originator: sasghm@theseus.unx.sas.com
Date: Fri, 18 Dec 1992 15:04:32 GMT
Organization: SAS Institute Inc.


In article <1992Dec17.201838.5426@dragon.acadiau.ca>, 880506s@dragon.acadiau.ca (James R. Skinner) writes:
|> werner@dewey.soe.berkeley.edu (John Werner) writes:
|> 
|> >In article <1992Dec15.172745.27468@newstand.syr.edu> Mark D. Kline writes:
|> >>I have started more than 600 people on prozac since 1987.  I have seen no
|> >>unusual discontinuation effects, and I have seen no unusual suicidality
|> >>or violent behavior.  
|> 
|> >This reminds me of a question I've been meaning to ask for a while.
|> >All of the medical professionals here say that there have been no
|> >reports Prozac causing suicidal or violent behavior.  But occasionally
|> >people will post anecdotal evidence: "It happened to me!"
|> 
|> >So my question is: what gives?  Did these people not report the
|> >reactions to their doctors?
|> 
|> I reported it immediatly but was told about the same as the above..
|> (ie  I have seen no violent behavior when prescribing prozac..)
|> 
|> > Did the doctors think it had nothing to
|> >do with Prozac?  
|> 
|> Yep, he didn't have any explanation for the feelings though.
|> 
|> >Did the doctors not want to deal with reporting it to
|> >the FDA?  Would anyone like to speculate?
|> 
|> No idea...
|> 
|> >I don't really have an axe to grind here, by the way.  I'm inclined to
|> >believe that most of these "reactions" aren't really caused by the
|> >drug.  I started taking it a week ago and haven't noticed anything
|> >unusual.
|> 
|> It has been my experience that this effects if the show up at all
|> doesn't appear until several months have passed..
|> 
|> -- 
|> 
|> -----------------------------------+--------------------------------------------
|>         James Robie Skinner        |     Jodrey School of Computer Science        James.Skinner@dragon.acadiau.ca  |  Acadia University, Wolfville, NS, Canada
|> -----------------------------------+--------------------------------------------

The _Physicians' Desk Reference_ makes interesting reading on some of these
questions.  Almost three full pages are devoted to Prozac.  It is, for example,
mentioned that 15% of about 4,000 patients who received Prozac in
premarketing clinical trials discontinued its use due to an adverse
effect.  Among the "more common events" resulting in discontinuation is
listed "psychiatric" with a figure of 5.3%.  (A bit more detail, but not
much, is given in the PDR.)

Perhaps of more interest is the following methodological disclaimer under
the heading of "Other Events Observed During the Premarketing Evaluation":

	Untoward events associated with this exposure were recorded
	by clinical investigators using descriptive terminology
	of their own choosing.  Consequently, it is not possible to
	provide a meaningful estimate of the proportion of individuals
	experiencing adverse events without first grouping similar
	types of untoward events into a limited(i.e., reduced) number of
	standardized event categories.
	(PDR, p. 922)


-- 
Gary H. Merrill  [Principal Systems Developer, C Compiler Development]
SAS Institute Inc. / SAS Campus Dr. / Cary, NC  27513 / (919) 677-8000
sasghm@theseus.unx.sas.com ... !mcnc!sas!sasghm