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CD-ROM Today (UK) (Spanish) 15
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00875.txt
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1994-01-17
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$Unique_ID{BRK00875}
$Pretitle{}
$Title{Ethical to Treat a Disease with an Unapproved Drug?}
$Subject{medicine medicines FDA unlabeled ethical drug drugs treatment
treatments labeling medication medications}
$Volume{R-0}
$Log{}
Copyright (c) 1991-92,1993 Tribune Media Services, Inc.
Ethical to Treat a Disease with an Unapproved Drug?
------------------------------------------------------------------------------
QUESTION: Is it right or ethical for a doctor to treat a disease with a drug
not approved for that use by the FDA? I need a straight answer.
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ANSWER: Yes, it can be considered both right and ethical. In fact, many
times "unlabeled" uses of approved drugs may be appropriate and often lead to
innovative and valid new uses for a drug, although under the law a drug may be
approved for marketing, labeled, promoted, and advertised ONLY for those uses
for which its safety and effectiveness have been established (Sect. 502 of the
Federal Food, Drug and Cosmetic Act).
A drug labeled for one disease might be found effective for an entirely
different medical condition, but to add the new use to the drug's labeling may
take years of time-consuming and costly clinical trials before its approval by
the FDA. Meanwhile the drug can be prescribed for the new indication provided
this use is safe and effective.
Labeling also warns against drugs that have been found unsafe or
ineffective for particular indications. The package inserts provide all such
information to help doctors make sound treatment decisions.
If you have some doubts about the particular use of a medication,
question your doctor. He may be able to provide you with some written
documentation that can help explain his use of your medication.
----------------
The material contained here is "FOR INFORMATION ONLY" and should not replace
the counsel and advice of your personal physician. Promptly consulting your
doctor is the best path to a quick and successful resolution of any medical
problem.