Clinical data are urgently needed to specify the risk and safety of drug use during
pregnancy. For several reasons pregnant women are usually excluded from clinical studies …

Purpose The results of observational cohort studies on drug effects on pregnancy outcome
may depend among others on suitable comparison cohorts. The aim of this investigation …

Scientifically valid data on the safety of drug use during pregnancy are a significant public
health need. Data are rarely available on the fetal effects of in utero exposure in human …

Pregnancy registries are the most commonly used data resource for the post-marketing
surveillance of drug teratogenicity. However, the limited sample size and potential selection …

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 …

In the absence of randomised controlled trials, knowledge of outcomes associated with
medication use during pregnancy is dependent on observational studies. Numerous …

Objective: Glaxo Wellcome becomes aware of prenatal exposures to its medications as early
as the clinical trial phase of development. An international process for monitoring prenatal …

Introduction: Prescription of medications to pregnant women is usually a challenge as the
drug benefit has to be considered regarding its potential adverse effects. As medication use …

Background The absence of robust evidence of safety of medicines in pregnancy,
particularly those for major diseases provided by public health programmes in developing …

Since, for obvious reasons, systematic testing of the teratogenic properties of drugs in
humans is not possible in the premarketing phase, the epidemiological approaches to …