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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.
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2 sty 2024 · The FDA has recently mandated significant modifications to the iPLEDGE program, which is designed to manage the risks associated with isotretinoin use. In this video, Dr John Barbieri of Brigham and Women’s Hospital and Harvard Medical School breaks down the details of the key updates.
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.
14 sty 2022 · The goals of the iPLEDGE REMS are to prevent fetal exposure to isotretinoin and to inform prescribers, pharmacists, and patients about isotretinoin’s serious risks and safe-use conditions.
13 lis 2023 · Learn about iPledge, the FDA-required program for all Accutane patients, designed to prevent pregnancy and ensure safe treatment. Learn how the iPledge program enforces vital safety protocols for patients starting Accutane therapy.
14 kwi 2023 · The committee members sought to balance reducing burden with maintaining safety and preventing fetal exposures to isotretinoin. Overall, their recommendations are aligned with the AADA’s recommendations: Over 75% of the committee voted to remove the 19-day lockout period.
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.
