Safety of prescribed drug use among pregnant women attending antenatal care in Midwestern Brazil: A cross-sectional study

Abstract

Background

Medication use during pregnancy is common but safety data remain limited. The FDA previously categorized drugs from A–X, later replaced by the Pregnancy and Lactation Labeling Rule (PLLR), which provides narrative risk summaries, clinical considerations, and supporting data.

Objective

To assess the safety of medications prescribed to pregnant women in Midwestern Brazil using both FDA categories and the PLLR.

Methods

This cross-sectional study reviewed medical records of women receiving prenatal care at a university outpatient clinic in Goiânia, Brazil. Patient characteristics, prescribed medications, and trimester of use were recorded. Each drug was classified by FDA categories and evaluated for PLLR structure.

Results

Of 93 women, 76 (81.7%) received at least one prescription (41 drugs; 241 prescriptions), most during the first trimester (61.8%). Supplements were the most frequent (38.6%), followed by analgesics/anti-inflammatory (26.6%) and gastrointestinal agents (17.0%). FDA categories were: 14.6% A, 41.5% B, 29.3% C, and 7.3% D. Under PLLR, 17 drugs (41.5%) had complete information; among 24 incomplete labels, the Data section was most often missing (46.3%), followed by Clinical Considerations (14.6%).

Conclusions

Most women received medications, mainly supplements and analgesics. Although FDA categories suggested low apparent risk, PLLR assessment revealed information gaps that limit evidence-based prescribing.