Lowery Kami, Rosen Theodore, Malek Janet
Ms. Lowery is with Baylor College of Medicine in Houston, Texas.
Dr. Rosen is with the Department of Dermatology at Baylor College of Medicine in Houston, Texas.
J Clin Aesthet Dermatol. 2020 Jun;13(6):54-56. Epub 2020 Jun 1.
Isotretinoin has unmatched efficacy in the treatment of acne. However, because isotretinoin is a teratogen that can cause profound birth defects, the iPLEDGE program regulates the drug's distribution in the United States. To minimize fetal exposure to isotretinoin, the program requires that female patients capable of becoming pregnant use two forms of contraception or commit to abstinence while using this therapy. This manuscript argues that iPLEDGE should be revised to remove abstinence as an acceptable contraceptive option in the face of evidence that disputes its efficacy. All patients, regardless of reported sexual activity, should be required to use data-proven contraception. Potential benefits of the proposed change (iPLEDGE-R) include reducing the number of isotretinoin pregnancies, increasing patient privacy protection, and standardizing patient care. Further investigation needs to guide additional strategies to achieve the program's public health goal; however, the ethical and pragmatic advantages of iPLEDGE-R merit consideration.
异维A酸在治疗痤疮方面具有无可比拟的疗效。然而，由于异维A酸是一种可导致严重出生缺陷的致畸剂，iPLEDGE项目对该药物在美国的分发进行监管。为了尽量减少胎儿接触异维A酸，该项目要求有怀孕可能的女性患者在使用这种疗法时采用两种避孕方式或坚持禁欲。本文认为，鉴于有证据对禁欲作为一种可接受的避孕选择的有效性提出质疑，iPLEDGE应进行修订，不再将禁欲作为一种可接受的避孕选择。所有患者，无论其报告的性活动情况如何，均应被要求采用经数据验证的避孕方法。提议的变更（iPLEDGE-R）的潜在益处包括减少异维A酸导致的怀孕数量、增强对患者隐私的保护以及使患者护理标准化。需要进一步开展调查以指导实现该项目公共卫生目标的其他策略；然而，iPLEDGE-R在伦理和实际操作方面的优势值得考虑。
