Artifact

iPLEDGE

FDA-required restricted-distribution program for isotretinoin, meant to prevent pregnancy during treatment.

2 links, 2 backed by primary records

Connections 2

U.S. Food and Drug Administration 2010 Primary record 1
FDA's page: the program has existed since 2005 and was approved as a formal REMS in 2010.

Timeline 1 date

Proof 1 source

Questions and Answers on the iPLEDGE REMS (FDA, content current as of 16 Jun 2026), U.S. Food and Drug Administration. Primary record
Isotretinoin can cause serious side effects, including birth defects. Because of the risk of severe birth defects, isotretinoin has only been available through a restricted distribution program called the iPLEDGE Program since 2005 and approved as the iPLEDGE REMS in 2010.

Page history 1 change