Re: ACOG/Cytotec -good news

From: art fougner, md (evsono@pipeline.com)
Wed Nov 1 14:51:49 2000


actually Dan - with regard to the use of cytotec in medical termination - the FDA is placed in the embarassing position of exactly that - recommending an off-label indication for which Searle has no desire to seek approval.

art

At Wed, 1 Nov 2000, Braun, R. Daniel wrote: >
> Nothing, they don't have any reason to take any action. The manufacturer
>has not requested any changes in labelling. No one has presented them with
>any studies showing that anything is wrong with the current labelling. There
>are not enough studies of the appropriate kind to get induction ofl labor
>added as an indication.
>If they even bother to respond, they will say OK, so what?
>Of course like Art, "I could be wrong." And I will be glad if I am.
>
>Dan
>
>-----Original Message-----
>From: Paul Prior MDTo: Multiple recipients of list OB-GYN-L
>Sent: 10/31/00 9:25 PM
>Subject: Re: ACOG/Cytotec -good news
>
>On Tue, 31 Oct 2000 19:06:41 -0600, eramirez@icepr.com (Efrain
>Ramirez) wrote:
>
>>ACOG NEWS RELEASE
>>
>> For Release: October 27, 2000
>>
>>ACOG Writes FDA on Safety of Misoprostol
>
>.deleted...
>
>By my initial read, this appears to be a balanced and reasoned
>response. I am pleased that it was done promptly and hope that all of
>our phone calls perhaps aided in this process in some way.
>
>Anyone have a sense of what the FDA will do on this?
>
>--
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--
art fougner, md

A series of 1000 cases begins with but a single anecdote.





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