FDA will require that patients receive a medication guide when prescribed immediate-release opioids, which may be a precursor to adding the products to the existing Risk Evaluation and Mitigation Strategy (REMS) for the extended-release version of the pain products.
Opioids And The Limits Of FDA Power
FDA adds a MedGuide for immediate-release opioids and shrinks their indication; the products seemed destined for an educational REMS, but is there even more the agency could do?