Reference:EU EMEA/CHMP/313666/2005 - GUIDELINE ON THE EXPOSURE TO MEDICINAL PRODUCTS DURING PREGNANCY: NEED FOR POST-AUTHORISATION DATA 14-Nov-2005 2.1

Document information
Reference	EU EMEA/CHMP/313666/2005 - GUIDELINE ON THE EXPOSURE TO MEDICINAL PRODUCTS DURING PREGNANCY: NEED FOR POST-AUTHORISATION DATA 14-Nov-2005
Validity area	EU
Scope(s)	HM
Document name	EMEA/CHMP/313666/2005 - GUIDELINE ON THE EXPOSURE TO MEDICINAL PRODUCTS DURING PREGNANCY: NEED FOR POST-AUTHORISATION DATA
Version / Revision	14-Nov-2005
Status	Current
Document type	Official guideline
Language(s)	EN
Description	EMEA/CHMP/313666/2005 COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) GUIDELINE ON THE EXPOSURE TO MEDICINAL PRODUCTS DURING PREGNANCY: NEED FOR POST-AUTHORISATION DATA
Official source	Official link
Restricted access	No
Submitted by	Florian Adragna
Contributors

Reference Details
Module	Module 5 — Unit 5.4.4
Scope	HM
Document part	2.1
Language	EN
Original entry by	Florian Adragna
Contributors
Tags	Pregnancy, Medicinal product, Risk, Trial participant
Comment	Medicinal products administered during pregnancy: background

Content

2.1 Background The majority of medicinal products or chemical substances administered to a pregnant woman could have effects on the foetus either before the placenta is fully developed or subsequently, if they can cross the placenta to at least some extent. Substances used for therapeutic purposes in the mother have the potential to reach the foetus with the consequential potential for harmful effects, depending on whether the rate and extent of drug transfer results in sufficient concentrations within the foetus.

Medicinal products may have a different impact at different stages of pregnancy. The spectrum of effects varies according to the period of exposure. For example, the exposure to a teratogenic agent during the period of organogenesis may induce major malformation, growth retardation or death, while exposure during the second or third trimester may induce growth retardation, renal insufficiency, neurological disorders, stillbirth, etc. On the other hand, exposure to a teratogenic agent during the first two weeks of pregnancy (3rd and 4th gestational week) may lead either to the death or to a normal preembryo according to the "all or nothing rule"; at this period zygotes and blastocysts contain omnipotent stem cells without any differentiation, therefore, teratogenic agents may lead to seriously damaged preembryos, which will not survive, or to less seriously damaged preembryos, which will survive with complete regeneration.

Drug treatment of male patients prior to or around the time of conception and/or during pregnancy could affect the offspring due to a drug-induced defect in the spermatozoon itself such as an effect on the DNA or chromosome or due to an effect caused by the presence of the drug in the seminal fluid.

Two important conclusions can be drawn from the above considerations: In order to minimise the foetal risk of exposure, drug therapy of the mother should be restricted as much as possible. This principle, however, cannot be applied in all cases. The mother may have a serious illness which requires treatment, or a condition that untreated may pose significant risk to the foetus. In order to optimise the knowledge about any potential teratogenic or embryotoxic/foetotoxic effects of a medicinal product and the doses and concentrations at which such effects will develop, it is desirable to gather information about all medicinal products taken by pregnant women.