Pflugfelder S, Gram E B, Damkier P
Department of Clinical Research, Faculty of Health Sciences, University of Southern Denmark, Odense, Denmark.
Department of Clinical Pharmacology, Odense University Hospital, Odense, Denmark.
Basic Clin Pharmacol Toxicol. 2025 Jun;136(6):e70048. doi: 10.1111/bcpt.70048.
Acetaminophen is the most used analgetic drug for pain management during pregnancy. A recent academic controversy concerns the safety of acetaminophen during pregnancy related to a potentially increased risk of adverse neurodevelopmental effects. We investigated the population-level trends in prescription-based use of acetaminophen among pregnant women in Denmark between 2001 and 2023. Prescription-based sals of acetaminophen among pregnant women and comparison groups were retrieved from 'eSundhed', a publicly available dataset curated by the Danish Health Authorities. The number of prescription-based drug users per 1000 pregnant women increased slightly from 2001 to 2012 (3.9 to 6.5 per 1000) and 2015 to 2023 (52 to 76 per 1000), interrupted by a drastic increase in 2013/2014. Acetaminophen use among pregnant women (2023: 76 per 1000) was lower than in women in an age-matched comparison group (137 per 1000) and in women 12-3 months prior to pregnancy (124 per 1000). Time trends did not notably differ between age groups or comparison groups. Prescription-based acetaminophen sales among pregnant women increased by 50% from 2015 to 2023. A general shift in the prescription pattern towards a substantial increase in prescription-based exposure was observed following legislation changes in 2013, restricting sales of large packages to prescription.
对乙酰氨基酚是孕期疼痛管理中最常用的镇痛药。最近的学术争议涉及对乙酰氨基酚在孕期的安全性,因为其可能会增加不良神经发育影响的风险。我们调查了2001年至2023年丹麦孕妇中基于处方使用对乙酰氨基酚的人群水平趋势。孕妇和对照组中基于处方的对乙酰氨基酚销售数据来自“eSundhed”,这是丹麦卫生当局整理的一个公开可用数据集。每1000名孕妇中基于处方的药物使用者数量在2001年至2012年(从每1000人3.9人增至6.5人)以及2015年至2023年(从每1000人52人增至76人)略有增加,不过在2013/2014年出现了大幅增长。孕妇中对乙酰氨基酚的使用情况(2023年:每1000人中有76人)低于年龄匹配对照组中的女性(每1000人中有137人)以及怀孕前12至3个月的女性(每1000人中有124人)。不同年龄组或对照组之间的时间趋势没有显著差异。从2015年到2023年,孕妇中基于处方的对乙酰氨基酚销售额增长了50%。2013年立法变更后,处方模式出现了总体转变,即基于处方的暴露量大幅增加,该变更限制了大包装药品只能凭处方销售。