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Mon, 7 Jun 2004 17:50:28 -0600 |
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The AAP lists Domperidone as a medication that is usually compatible with
breastfeeding. Wonder why the FDA doesn't take that into consideration?
For anyone who is interested, the AAP put out a policy paper on off-label
use of meds...
"http://aappolicy.aappublications.org/cgi/content/full/pediatrics;110/1/181"
"The FDA regulates the manufacture, labeling, and promotion of drugs; it
does not regulate the use of drugs by physicians (ie, the practice of
medicine)." Seems to me that is exactly what the FDA is doing here.
"Off-label use does not imply an improper use and certainly does not imply
an illegal use or a contraindication based on evidence. Explicit
evidence-based warnings and contraindications are provided in product
labels. The distinction between lack of FDA approval of a use or dosing
regimen and explicit warnings or contraindications against uses is important
medically and legally. "
Maybe the FDA should talk to the AAP...
If writing a letter to the FDA pointing out their inconsistencies will do
any good, I plan to do that.
I don't see how it can be illegal to get the med from a compounding
pharmacy. I guess I'll have to break down and read the actual "Act" to see
how they think that they have that much power.
Regards,
Cindi Swisher
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