Albogami Yasser, Almadani Ohoud, Almohareb Sumaya N, Alshehri Sultan, Alkhaibari Abdullah, Anzan Mona, Alsharif Alaa, Alhossan Abdulaziz, Alrwisan Adel
Department of Clinical Pharmacy, College of Pharmacy, King Saud University, King Khalid Road, PO Box 145111, Riyadh 12372, Saudi Arabia.
Saudi Food and Drug Authority, Riyadh, Saudi Arabia.
Ther Adv Drug Saf. 2024 Sep 12;15:20420986241272822. doi: 10.1177/20420986241272822. eCollection 2024.
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.
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.
Retrospective cohort study.
This multicenter retrospective study included a cohort of 6233 women of childbearing ages (WCBAs) who had received isotretinoin therapy between 2015 and 2020. Exposure to isotretinoin use was ascertained from patients' electronic health records and was defined as any positive pregnancy test (urine or serum) or any diagnosis or procedure related to pregnancy occurring during the risk period. We defined the risk period starting from isotretinoin initiation until up to 30 days after the last prescription. We quantified the overall incidence proportion of fetal exposure to isotretinoin by dividing the number of pregnancy cases during the risk period by the total study sample of WCBAs.
The cohort predominantly included young females (20-29 years), with a mean age of 24 years. Only 5% of the WCBAs used contraceptives, and 10% have a record of pregnancy testing. During the risk period, 34 pregnancies were identified, yielding a cumulative pregnancy incidence of 5.6 per 1000 WCBAs. Pregnancy outcomes for exposed women were about 5% of births had defects, while abortions accounted for 14.3% of pregnancies.
Our investigation shows an alarming incidence of fetal exposure to isotretinoin in Saudi Arabia, substantially surpassing global estimates. These results underscore a critical need for enhanced interventions and robust risk minimization strategies tailored to the distinct challenges faced by the Saudi Arabian population.
尽管异维A酸在治疗重度痤疮方面疗效显著，但其与包括致畸性在内的严重副作用相关。然而，沙特阿拉伯孕期异维A酸的暴露程度仍不明确。
本研究旨在量化沙特阿拉伯胎儿异维A酸暴露程度，并评估对沙特食品药品管理局批准的风险最小化措施的依从性。
回顾性队列研究。
这项多中心回顾性研究纳入了2015年至2020年间接受异维A酸治疗的6233名育龄妇女队列。从患者电子健康记录中确定异维A酸使用暴露情况，定义为在风险期内任何阳性妊娠试验（尿液或血清）或任何与妊娠相关的诊断或程序。我们将风险期定义为从开始使用异维A酸直至最后一次处方后30天。通过将风险期内妊娠病例数除以育龄妇女总研究样本数，我们量化了胎儿异维A酸暴露的总体发病率。
该队列主要包括年轻女性（20 - 29岁），平均年龄为24岁。只有5%的育龄妇女使用避孕药具，10%有妊娠检测记录。在风险期内，确定了34例妊娠，育龄妇女累积妊娠发病率为每1000人中有5.6例。暴露妇女的妊娠结局约5%的出生有缺陷，而流产占妊娠的14.3%。
我们的调查显示沙特阿拉伯胎儿异维A酸暴露发生率令人担忧，大大超过全球估计。这些结果强调迫切需要加强干预措施，并制定强有力的风险最小化策略，以应对沙特阿拉伯人群面临的独特挑战。
