Pregnant women and their fetuses — orphan populations in respect to the safety and efficacy of medicines

Abstract

Pregnant women are a very special category of patients. The risk-benefit ratio of using various drugs in this case presents a significant medical, social and ethical problem. The increase in the age of onset of the first pregnancy is associated with the increasing prevalence of chronic pathology. Obesity, cardiovascular diseases, diabetes mellitus, hypo- or hyperfunction of the thyroid gland, as well as many other conditions contribute to the active use of drugs of various pharmacological groups throughout the entire period of pregnancy, including early periods. The current practice of pharmacotherapy in pregnant women is based mainly on the use of drugs with an uncertain teratogenic risk. Not including pregnant women in clinical trials is an ethical issue as significant as their potential inclusion. Previously, for a long time, vulnerable categories included generally all women of reproductive age, whose inclusion in clinical trials became possible only in the mid-1990s. Pregnant women were considered vulnerable until 2019. The orphan status of pregnant women in terms of inclusion in clinical trials limits their right to receive highly effective and safe medical care, which makes it relevant to review the existing ethical principles in relation to this category of patients and a to perform a detailed analysis of existing barriers for certain types of drug trials.