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Subject:
From:
Alicia Dermer <[log in to unmask]>
Reply To:
Lactation Information and Discussion <[log in to unmask]>
Date:
Mon, 17 Mar 1997 13:54:52 -0500
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Bonnie:  I'm not a legal expert, but as a physician I am aware of an
example in which the PDR may not necessarily be the ultimate authority on
drug use.  Although not breastfeeding-related, it points out one of the
limitations of the PDR.

It is quite a common practice for physicians to
prescribe FDA (Food and Drug Administration) approved medications for
indications for which the FDA has not approved them.  For example, if
drug A was approved for hypertension but in some good studies was shown
to be useful for heart failure, it would take too long for the drug to go
through the FDA approval process for that indication, so it's standard of
care for physicians to prescribe the drug for a non-approved indication
under such circumstances.  If a physician was legally challenged on this
practice, the PDR would only have the FDA approved use listed, but I
doubt that he/she would be successfully sued on this basis if there was
good literature to back up the practice.  Hope this helps.  Alicia.
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