Re: sidual dysplasia
From: art fougner, md (evsono@pipeline.com)
Sat Jan 3 13:04:57 2004
the phen-fen combo was NOT an FDA approved use - the classic off-label
disaster. OTH the classic ON - Label disaster was the Bendectin fiasco.
art
At Sat, 3 Jan 2004, Charlie Chambers wrote:
>
>Art
>
>As long as some evidence supports the off label use, then it's a
>reasonable prescribing practice. We have so many medicines that do not
>have a "label" indication that are used every day but we are mostly
>unaware of the practice. For example, in preterm labor, ritodrine is
>the only tocolytic with FDA labeling for use. Yet, I can't remember the
>last time, I was aware of anyone using it. Further, the majority of
>medications used in the pediatric population do not have an FDA
>labeling use. Lastly, the FDA labeling doesn't protect you from any
>adverse or untoward events, e.g. Baychol, Phen-Fen, breast implants,
>and probably Prempro.
>
>On Jan 3, 2004, at 8:46 AM, art fougner, md wrote:
>
>> I don't believe MgSO4 was approved for eclampsia. and ASA antedates
>> the
>> FDA. OTH off label indications put the onus totally on the
>> practitioner
>> so ...
>>
>> art
>>
>> At Fri, 2 Jan 2004, RModugno@aol.com wrote:
>>>
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>>> In a message dated 1/2/2004 1:58:24 PM Eastern Standard Time,
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>>> cchamber@gorge.net writes:
>>> I was then chastised
>>>> by a physician because I was using this off label
>>>> and was very liable for lawsuit. I discussed it
>>>> with the Aldara rep who, of course, could not
>>>> recommend that usage.
>>>
>>> Once a drug is apporved by the FDA - you can use it for "off-label"
>>> uses
>>> provided there is medical literature to back up this use.
>>> e.g.terbutaline is not approved for the treatment of premature labor.
>>>
>>> Robert Modugno MD MBA FACOG
>>> Marietta, GA
>>> http://www.novaobgyn.yourmd.com
>>>
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>>> In a message dated 1/2/2004 1:58:24 PM Eastern Standard Time,
>>> cchamber gorge.net writes:
>>> I was then chastised> by a physician b cause I was using this off
>>> label> and was very liable for lawsuit. I discussed it> with the
>>> Aldara rep who, of course, could not> ecommend that usage.
>>> Once a drug is apporved by the FDA - you can use it for "off-label"
>>> us s provided there is medical literature to back up this use.
>>> e.g.terbutaline is not approved for the treatment of premature labor.
>>>
>>> Robert Modugno MD MBA FACOG
>>> Marietta, GA
>>> http://www.novaobgyn.yourmd.com
>>>
>>> -------------------------------1073081945--
>>>
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>>
>> --
>> art fougner, md
>> ich bin ein New Yorker
>>
--
art fougner, md
ich bin ein New Yorker
