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A comparison of iPLEDGE requirements to risk mitigation programs for isotretinoin in other countries and to other teratogenic medications in the United States.
J Am Acad Dermatol
January 2025
The George Washington University School of Medicine and Health Sciences, Department of Dermatology, Washington, DC 20052; Children's National Hospital, Division of Dermatology, Washington, DC 20010.
Usefulness and limitations of ChatGPT in getting information on teratogenic drugs exposed in pregnancy.
Obstet Gynecol Sci
November 2024
Korean MotherSafe Counselling Center, Pregnancy & Breastfeeding Medicines Information Center, Seoul, Korea.
There is a growing interest in using artificial intelligence (AI) technology to obtain information on the risk and safety of drugs in pregnancy. Inadvertent drug exposure in pregnant women is inevitable in acute or chronic diseases, especially in unplanned pregnancies. According to the Korean mother safe counselling center database (2010-2023), many Korean pregnant women and their families asked about the teratogenicity of their exposed drugs.
View Article and Find Full Text PDFBackground Practicing and following a Pregnancy Prevention Program (PPP) is crucial to prevent isotretinoin-induced teratogenicity. Our study aims to assess the current practice of dermatologists about PPP when prescribing oral isotretinoin and the compliance of the patients toward contraceptive methods. Methods The research used a cross-sectional design and utilized a probability sampling method in Saudi Arabia.
View Article and Find Full Text PDFEvaluating the Readability of the iPledge Comprehension Assessment and its Impact on Isotretinoin Accessibility.
Pediatr Dermatol
September 2024
The George Washington University School of Medicine and Health Sciences, Washington, DC, USA.
Isotretinoin, the standard treatment for severe nodular acne, is subject to stringent iPLEDGE regulations due to its teratogenic risks, requiring monthly assessments for patients of childbearing potential. Analysis of the iPLEDGE Comprehension Assessment (iPCA) revealed an average readability score of grade 8.5, exceeding the recommended grade 6 level for optimal patient comprehension.
View Article and Find Full Text PDFFetal exposure to isotretinoin in Saudi Arabia: a multicenter real-world data analysis from 2015 to 2020.
Ther Adv Drug Saf
September 2024
Saudi Food and Drug Authority, Riyadh, Saudi Arabia.
Background: Despite its high efficacy in treating severe acne, isotretinoin is associated with serious side effects, including teratogenicity. However, the extent of isotretinoin exposure during pregnancy in Saudi Arabia remains unknown.
Objectives: This study aims to quantify the extent of fetal exposure to isotretinoin in Saudi Arabia and to evaluate adherence to risk minimization measures approved by the Saudi Food and Drug Authority.
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