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[quote=Anonymous][quote=Anonymous]why not talk to the doctor and ask why they prescribed. as said before plenty of medications have studies that have been ongoing to allow for prescribing outside the approved windows [b][u]while they await approval[/u] [/b]
[/quote]

Or even if the manufacturer never intends to apply for such pediatric approval.

From the American Academy of Pediatrics (AAP):

[quote][b]Off-label use does not imply an improper use and certainly does
not imply an illegal use or a contraindication based on evidence.[/b] Explicit evidence-based warnings and contraindications are provided in product labels. [b]The distinction between lack of FDA approval of a use or dosing regimen and explicit warnings or contraindications against uses is important medically and le
gally.[/b]

Uses of Drugs Not Described in the Package Insert (Off-Label Uses)
https://watermark02.silverchair.com/pe0702000181.pdf[/quote]

The AMA and AAFP have published similar statements consistent with this.

However, it is possible that OP is referring to an explicit counterindication, which would be a different matter entirely. OP, what is the drug? [/quote]

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