"Off label" means using an FDA-approved drug for a use for which it was not
approved or licensed (eg. using Reglan to increase milk supply when it was
licensed for GI problems).
Domperidone has never been FDA approved in the US, so its use is not
"off-label" - it is illegal per the FDA, but legal per the Compounding
Pharmacists Association. The FDA has threatened many docs into not prescribing it -
at the cost of losing their medical license.
Nancy
Nancy E. Wight MD, IBCLC, FABM, FAAP
Neonatologist
Sharp Mary Birch Hospital for Women and Newborns
Medical Director, Sharp HealthCare Lactation Services
San Diego, CA
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