Abstract
Background. To estimate the exposure to medicines with unknown fetal risk during pregnancy and to analyze the maternal characteristics associated with it. Methods. A questionnaire was administered to 4,189 mothers of children belonging to the 2004 Pelotas (Brazil) birth cohort study about use of any medicine during gestation. We evaluated the associations between use of medicines with unknown fetal risk and the independent variables through logistic regression models. Unknown fetal risk was defined as medicines in which studies in animals have revealed adverse effects on the fetus, and no controlled studies in women, or studies in women and animals, are available. Results. Out of the 4,189 women, 52.5% used at least one medicine from unknown fetal risk. Use of these medicines was associated with white skin color, high schooling, high income, six or more antenatal care consultations, hospital admission during pregnancy, and morbidity during gestation. Conclusion. The use of unknown fetal risk medicines is high, suggesting that their use must be addressed with caution with the aim of restricting their use to cases in which the benefits are greater than the potential risks.
Highlights
To estimate the exposure to medicines with unknown fetal risk during pregnancy and to analyze the maternal characteristics associated with it
A questionnaire was administered to 4,189 mothers of children belonging to the 2004 Pelotas (Brazil) birth cohort study about use of any medicine during gestation
We evaluated the associations between use of medicines with unknown fetal risk and the independent variables through logistic regression models
Summary
To estimate the exposure to medicines with unknown fetal risk during pregnancy and to analyze the maternal characteristics associated with it. Most studies evaluating the risk that medicines pose to the fetus used the US Food and Drug Administration (FDA) classification [15]. Such studies have shown that exposure to category A medicines (considered safe during pregnancy) occurred in 49% to 100% of the participating women [5, 7, 16, 17]. Medicines with evidence of fetal risk (category D and X) were used by less than 12% of pregnant women [1, 5, 7, 17,18,19,20], with the exception of a study conducted in France, in which the percentage of exposure to category D drugs was 59% [16]. Many studies focused on the factors associated with the use of products from categories D or X [18, 19, 21, 22]
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