Zamil Dina H, Paidisetty Praneet S, Wang Leonard K
Baylor College of Medicine, Houston, Texas.
McGovern Medical School, The University of Texas Health Science Center, Houston, Texas.
Proc (Bayl Univ Med Cent). 2022 Aug 19;35(6):892-893. doi: 10.1080/08998280.2022.2111643. eCollection 2022.
Isotretinoin is an acne medication regulated by the Food and Drug Administration (FDA) iPledge Risk Evaluation and Mitigation Strategy program due to its potential for birth defects. This program enforces monthly pregnancy tests and comprehension quizzes, among other requirements, which results in disproportionate medication access barriers. In December 2021, the iPledge system underwent a series of changes, which resulted in systemwide malfunctions and hour-long phone support line waiting times. Due to growing challenges to isotretinoin access, patients may turn to unregulated over-the-counter vitamin A dietary supplements marketed for acne, despite evidence of similar risk of teratogenicity to isotretinoin. While the FDA has understandably focused its attention to isotretinoin regulation, it should increase oversight of the dietary supplement industry, and practitioners should remain informed of risks of vitamin A supplements.
异维A酸是一种治疗痤疮的药物，由于其有致畸风险，受美国食品药品监督管理局（FDA）的iPledge风险评估与缓解策略计划监管。该计划强制要求每月进行妊娠测试和理解能力测验等，这导致了药物获取方面不成比例的障碍。2021年12月，iPledge系统经历了一系列变更，导致全系统故障以及长达一小时的电话支持热线等待时间。由于异维A酸获取面临的挑战日益增加，尽管有证据表明非处方维生素A膳食补充剂对痤疮的致畸风险与异维A酸相似，但患者可能会转向这些不受监管的产品。虽然FDA将注意力集中在异维A酸监管上是可以理解的，但它应该加强对膳食补充剂行业的监管，从业者也应该了解维生素A补充剂的风险。
