Off-Label (Cont.)

Off-Label Use in Children

Medication use in children is often off-label, as many of the medications commonly used in children have never been approved for use in children. Research studies involving children were once considered unethical, and such studies often carry huge legal risks for drug companies. The FDA is attempting to remedy this problem by financially encouraging drug companies to perform studies in children, especially for medications that are already commonly used in children.
 

Talking to Your Healthcare Provider About Off-Label Uses

You should feel free to ask your healthcare provider if you are using your medications "off-label." Keep in mind that the best medication for your situation may indeed be one that is used off-label. Be sure to talk with your healthcare provider about the benefits and risks of using a medication off-label. Ask if there is any scientific evidence to support such a use and whether your healthcare provider has experience using the medication for this use in the past.

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Written by/reviewed by: Kristi Monson, PharmD; Arthur Schoenstadt, MD
Last reviewed by: Kristi Monson, PharmD;