Sheffield L J, Batagol R
Med J Aust. 1985 Aug 19;143(4):143-7. doi: 10.5694/j.1326-5377.1985.tb122871.x.
The drug combination Debendox has been very widely used for the treatment of nausea and vomiting in pregnancy. Recently its manufacturer ceased world-wide production owing to the increasing costs of litigation associated with claims of teratogenicity. Teratogenicity claims were widespread in the media but the overwhelming scientific evidence was that Debendox was not teratogenic. In the interests of preventing other drugs (and drug companies) being subjected to similarly unfounded claims, the literature relating to the effects of Debendox on the fetus has been reviewed and evaluated against well known epidemiological principles of establishing causality. This evaluation consistently demonstrates that Debendox is not in fact teratogenic. It is recommended that appropriate professional bodies be more aware of the criteria by which causation is established and be prepared publicly to state their considered views of the effects of particular drugs in pregnancy.
复方多西拉敏已被广泛用于治疗妊娠期间的恶心和呕吐。最近,由于与致畸性索赔相关的诉讼成本不断增加,其制造商停止了全球生产。致畸性索赔在媒体上广泛传播,但压倒性的科学证据表明复方多西拉敏没有致畸性。为了防止其他药物(以及制药公司)遭受同样毫无根据的索赔,已根据确定因果关系的著名流行病学原则,对有关复方多西拉敏对胎儿影响的文献进行了审查和评估。该评估一致表明,复方多西拉敏实际上并无致畸性。建议相关专业机构更加了解确立因果关系的标准,并准备好公开陈述他们对特定药物在妊娠期间影响的审慎看法。