Vanhauwere B, Maradit H, Kerr L
F. Hoffmann-La Roche, Pharma Development Safety Drug Safety, Basel, Switzerland.
Am J Trop Med Hyg. 1998 Jan;58(1):17-21. doi: 10.4269/ajtmh.1998.58.17.
The purpose of this study was to evaluate the teratogenic potential of mefloquine (Lariam) in pregnancy, based on the Roche International Spontaneous Reporting System. Lariam is an anti-malarial drug used both in prophylaxis and treatment of malaria. Teratogenic effects were observed in animals but data from humans are lacking. Women of childbearing potential are currently advised to take contraceptive precautions up to three months after the last dose. The study included 1,627 spontaneous reports of women exposed to Lariam before or during pregnancy, which were received by Roche worldwide since introduction on the market. The data were analyzed considering pregnancy and fetal outcome and type of congenital malformations. The birth prevalence of congenital malformations in women exposed to Lariam is estimated to be 4% and is not different from the prevalence observed in the general population. In addition, the congenital malformations observed with Lariam exposure do not show any specific pattern. The data from our study suggest that the teratogenicity, which was observed in animals at high doses, cannot be applied to humans.
本研究的目的是基于罗氏国际自发报告系统，评估孕期使用甲氟喹（Lariam）的致畸潜力。Lariam是一种用于预防和治疗疟疾的抗疟药物。在动物身上观察到了致畸作用，但缺乏来自人类的数据。目前建议有生育潜力的女性在最后一剂药物服用后三个月内采取避孕措施。该研究纳入了1627例在孕期前或孕期接触过Lariam的女性自发报告，这些报告自该药物上市以来由罗氏公司在全球范围内收集。对数据进行了分析，考虑了妊娠情况、胎儿结局以及先天性畸形的类型。接触过Lariam的女性中先天性畸形的出生患病率估计为4%，与普通人群中观察到的患病率没有差异。此外，接触Lariam后观察到的先天性畸形没有显示出任何特定模式。我们研究的数据表明，在高剂量动物实验中观察到的致畸性不能应用于人类。
