The safety of calcium channel blockers during pregnancy: a prospective, multicenter, observational study.

Objective: To assess the safety of calcium channel blockers during the first trimester of pregnancy.

Study Design: A multicenter (n=11), prospective observational study of the European Network of Teratology Information Services (ENTIS). The rate of major birth defects was compared between a cohort of pregnant women exposed to calcium channel blockers during the first trimester (n=299) and a control group not exposed to potential teratogens (n=806).

Vitamin K antagonists and pregnancy outcome. A multi-centre prospective study.

Vitamin K antagonists (VKA) are known to act as teratogens; however, there is still uncertainty about the relative risk for birth defects and the most sensitive period. In a multi-centre (n = 12), observational, prospective study we compared 666 pregnant women exposed to phenprocoumon (n = 280), acenocoumarol (n = 226), fluindione (n = 99), warfarin (n = 63) and phenindione (n = 2) to a non-exposed control group (n = 1,094). Data were collected by institutes collaborating in the European Network of Teratology Information Services (ENTIS) during individual risk counselling between 1988 and 2004.

Post-marketing surveillance system for drugs in pregnancy--15 years experience of ENTIS.

Teratology Information Services (TIS) provide the public and health professionals with tailor-made information on drug risks in pregnancy. TIS in Europe, Israel and Latin America collaborate in the European Network of Teratology Information Services (ENTIS) in order to optimise interpretation of risk data, risk communication and risk management as well as recommendations for drug treatment in pregnant women. In addition, efforts are undertaken to enhance and harmonise documentation of exposed pregnancies and their outcomes.