Mufaddal Mahesri, Ameet Sarpatwari, Krista F Huybrechts, Joyce Lii, Su Been Lee, Gita A Toyserkani, Cynthia LaCivita, Esther H Zhou, Gerald J Dal Pan, Aaron S Kesselheim, Katsiaryna Bykov
INTRODUCTION: Lenalidomide, pomalidomide, and thalidomide are effective treatments for multiple myeloma but are teratogenic. To mitigate this risk, the US Food and Drug Administration (FDA) required risk evaluation and mitigation strategy (REMS) programs for these drugs, which include pregnancy testing among women of childbearing potential-twice before initiation, weekly in the first month on treatment, and every 2-4 weeks thereafter. OBJECTIVE: We evaluated dispensing trends of lenalidomide, pomalidomide, and thalidomide and assessed adherence to REMS pregnancy testing requirements among at-risk patients taking these drugs...
May 16, 2024: Drug Safety: An International Journal of Medical Toxicology and Drug Experience