Drug treatment in pregnancy

When considering drug therapy in pregnancy, the risk of treatment for the e mbryo/fetus has to be weighed against the risk to the mother and the child of carrying out no treatment. This is of particular relevance in certain co nditions like diabetes, epilepsy or AIDS, where the risk of embryopathy is increased when no treatment is carried out and the available drugs are pote ntially teratogenic. However, carefully selected drugs and close meshed mon itoring may even decrease the risk for the child. In many instances, uninte ntional drug exposure occurs in the period before the pregnancy has been di agnosed. This may lead to additional diagnostic measures or even abortion o f an otherwise wanted child. In both situations, planned and unintentional drug exposure during pregnancy, insufficient information is available on th e clinical conditions relevant here and the specific drugs involved. Identi fication of potential teratogenic effects of a new drug takes place during the early development phase. However, animal models may not be representati ve of specifically human characteristics, e.g. deficiences in enzymes. Sinc e drug treatment is generally best avoided during pregnancy, pharmacokineti c studies in this population are rare. However, physiological changes, know n to be relevant for some drugs do occur during pregnancy. In order to impr ove knowledge on the pharmacokinetics of drugs in pregnancy, population pha rmacokinetic approaches may represent a Solution. Intensive efforts to inve stigate the efficacy and safety of drugs during pregnancy are necessary. Si nce controlled clinical trials are usually not feasible due to ethical reas ons, intensified collection of case reports as well as epidemiological stud ies are warranted to gain sufficient information for the counselling of pre gnant women.