The importance of pharmacoepidemiology in pregnancy-implications for safety

ABSTRACT

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 is common in pregnant women, by chance or necessity, it gives the opportunity to evaluate the consequences of prenatal drug exposure in real life through pharmacoepidemiologic studies.

Area covered: Data sources are numerous. Some of them have been created for the particular purpose of assessing medications during pregnancy. Augmented databases enable the study of delayed effects in late childhood and provide information on potential confounders. Each data source exhibits strengths and weaknesses. Several designs can be used to assess the safety of medications during pregnancy. Innovative designs have been developed in order to bypass major limits of classical methods.

Expert opinion: An efficient system could follow up each pregnant woman, who had taken a medication, and consider her as a precious information for the knowledge of drug potential adverse actions against the child, who must be followed up to identify long term-effects. The diversity of data sources and approaches of pharmacoepidemiologic studies, the implementation of international networks as well as the improvement of adverse signal detection are the keystones of such an evaluation.

KEYWORDS:

• Electronic database
• medication
• pharmaco-epidemiology
• pregnancy
• teratogen

Article highlights

• Drug induced risks in pregnancy are considered as different phenomenon from other drug-induced hazards

• Since pregnant women are usually not included in clinical trials for ethical reasons, post-marketing assessment of medication use during pregnancy is mandatory.

• As the risk of specific malformations is rather low, studies must be conducted on large size samples.

• Data sources are numerous and each of them exhibit strengths and weaknesses that can be exceeded using innovative designs

• The diversity of data sources and approaches as well as the implementation of international networks are the keystones of drug evaluation in pregnancy

This box summarizes key points contained in the article.

Declaration of interest

No potential conflict of interest was reported by the authors.