Terafar - Izmir Katip Celebi University Teratology Information, Training and Research Center, Izmir, Turkey; Izmir Katip Celebi University School of Medicine, Department of Pharmacology, Izmir, Turkey.
Terafar - Izmir Katip Celebi University Teratology Information, Training and Research Center, Izmir, Turkey; Izmir Katip Celebi University School of Medicine, Department of Pharmacology, Izmir, Turkey.
Reprod Toxicol. 2018 Mar;76:103-108. doi: 10.1016/j.reprotox.2018.01.003. Epub 2018 Jan 31.
The 2014 report by European Medicines Agency (EMA) restricted the use of thiocolchicoside for all reproductive-age women. In this study, we aim to expand the systematically-collected human data and discuss it within the frame provided by this report.
We identified and evaluated the outcomes of 48 prospectively recorded pregnancies referred to Terafar (Teratology Information Service, Izmir, Turkey).
Of 42 pregnancies with first-trimester exposure and known outcomes, 31 resulted in live births, four in miscarriage and seven ended with elective terminations. There were 26 normal outcomes, two major and three minor congenital malformations among the live births.
Despite a number of limitations, our results and previous case series collectively strengthen the view that thiocolchicoside is unlikely to be a major teratogen. EMA's 2014 report should be revised to reflect this finding, while current restrictions on use should continue until more detailed safety information is available.
欧洲药品管理局（EMA）在 2014 年的报告中限制了噻氯匹定在所有育龄妇女中的使用。本研究旨在扩大系统收集的人类数据，并在该报告提供的框架内进行讨论。
我们鉴定并评估了来自土耳其伊兹密尔 Terafar（畸形学信息服务）的 48 例前瞻性记录的妊娠结局。
42 例妊娠在妊娠早期接触噻氯匹定，且已知结局，31 例活产，4 例流产，7 例选择性终止妊娠。在活产儿中，有 26 例正常结局，2 例严重畸形和 3 例轻度畸形。
尽管存在一些局限性，但我们的结果和以前的病例系列共同表明噻氯匹定不太可能是一种主要致畸物。EMA 的 2014 年报告应进行修订以反映这一发现，同时在获得更详细的安全性信息之前，应继续限制噻氯匹定的使用。
