The iPLEDGE REMS is a safety program to manage the risk of isotretinoin’s teratogenicity and to minimize fetal exposure. The REMS is required by the U.S. Food and Drug Administration (FDA) to ensure the benefits of isotretinoin outweigh its risks.

2016年1月20日 · The iPLEDGE REMS is a computer-based risk management system that uses verifiable, traceable links between prescriber, patient, pharmacy, and wholesaler to control prescribing, using, dispensing, and distribution of isotretinoin.

This system is for the use of authorized users only. Individuals using this computer system without authority, or in excess of their authority, are subject to having all of their activities on this system monitored and recorded by systems personnel.

The iPLEDGE PROGRAM REMS is a safety program to manage the risk of isotretinoin’s teratogenicity and to minimize fetal exposure.