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Isotretinoin Risk Evaluation and Mitigation Strategy and Pregnancy Incidence

Zhu Y, Anand P, Sarpatwari A, Hernández-Díaz S, Bykov K, Kesselheim AS, Avorn J, Vine SM, Adomi M, DiCesare EC, Mahesri M, Zakoul H, Mogun H, Toyserkani GA, LaCivita C, Zhou EH, Dal Pan GJ, Huybrechts KF - JAMA Internal Medicine

Research Publications

| October 2025

Regulation and Clinical Evidence

Summary:

Initiation of isotretinoin under the iPLEDGE risk evaluation and mitigation strategy (REMS) program was associated with a 70%–80% lower pregnancy incidence than topical retinoids across publicly and commercially insured patients, though differences persisted by insurance type and race/ethnicity. Despite these reductions, fetal exposre to isotretinoin still occurred, highlighting the need for strategies to improve adherence to REMS requirements.

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