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eMediNexus 06 February 2018
The 2014 report by European Medicines Agency (EMA) restricted the use of thiocolchicoside for all reproductive-age women. A new article published in Reproductive Toxicology aimed to expand the systematically-collected human data and discuss it within the frame provided by this report. This study identified and evaluated the outcomes of 48 prospectively recorded pregnancies referred to Terafar (Teratology Information Service, Izmir, Turkey). The findings showed that out 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. From the results, it was inferred that thiocolchicoside is unlikely to be a major teratogen. Nevertheless, it was recommended that current restrictions on use should continue until more detailed safety information is available.
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