Background/Objectives: While breastfeeding is highly recommended, breastfed infants may be exposed to drugs by milk due to maternal pharmacotherapy, resulting in a risk of adverse drug events (ADE) or reactions (ADRs). The U.S. Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) is an online pharmacovigilance database, while the Drugs and Lactation Database (LactMed^®) includes accurate and evidence-based information on levels of substances in breast milk and infant blood, and possible ADRs in nursing infants. We aimed to explore the FAERS database and compare ADE/ADR information patterns between both databases. Methods: The FAERS database was explored (29 July 2024) for ADEs related to drug exposure during lactation to determine annual trends, infant outcomes, and regions of reporting. The active pharmaceutical ingredients (APIs) associated with these ADEs were categorized based on the Anatomical Therapeutic Chemical (ATC, first level) classification. The top five APIs in each ATC group were explored in terms of the type of ADEs reported and compared to information in LactMed^®. Results: In total, 2628 ADEs were obtained from the FAERS database, with increased reporting over time. In the FAERS database, 68.4% of the patients were under 2 months old, 5.5% had life threatening ADEs, and 3.6% died, while 84.70% of the cases were categorized as serious. Most ADEs were from North America (44.9%). Most drugs (50.9%) were nervous system drugs. The most frequent reported outcome was “other outcomes (without additional subdivision or information)” (58.2%), reflecting the diversity in outcomes reported. When related to the same drug, the FAERS database and LactMed^® resource exhibited both similarities and differences in the types of reported ADE/ADR. Conclusions: The FAERS database is a useful tool to detect potential ADEs (rather sensitive), without ADR assessment, while LactMed^® provides guidance driven by relevant ADRs (rather specific). The FAERS database is useful to obtain exploratory information about ADEs during lactation to increase the knowledge about drug safety during breastfeeding and the awareness of the possible risks in nursing infants, while LactMed^® translates all available information into guidance.

Background: Proton pump inhibitors (PPIs) are widely used for gastric acid suppression, yet their efficacy and safety in neonates and infants remain unclear. While esomeprazole is the only Food and Drug Administration (FDA)-approved PPI for neonates and infants under 1 year of age, other PPIs are also frequently prescribed. Objectives: This study utilizes FDA Adverse Event Reporting System (FAERS) data to evaluate potential adverse drug events (ADEs) of PPIs, providing crucial real-world insights into their safety in this vulnerable population. Methods: This observational cross-sectional study was conducted using an individual case safety report (ICSR) database. Only reports in neonates or infants receiving omeprazole, pantoprazole, lansoprazole, rabeprazole, or esomeprazole monotherapy were evaluated. The most frequently prescribed PPI, the most common indication, the most reported ADE, the seriousness of AEs, and the countries reporting the highest ADE number were analyzed using 2D disproportionality analyses (e.g., reporting odds ratio (RORs)). Results: A total of 464 patients were included; 323 (69.6%) of them were stated as serious and 15 (3.2%) of them were stated as time-related to mortality. Most of the ADEs were reported for lansoprazole (45.9%). The most reported PPI-associated ADE was vomiting (8.8%). According to the RORs analysis, vomiting associated with PPI monotherapy was more likely to occur (RORs: 2.88, 95% CI: 2.09–3.96), which is followed by diarrhea, hypertrichosis, choking, and erythema. Additionally, medication errors were reported in 50 (10.8%) patients. Conclusions: ICSR databases are valuable pharmacovigilance tools. The absence of access to a causality assessment is a limitation since it limits its ability to confirm whether the ADEs are truly caused by the suspected drug, mitigated using RORs analysis. Integrating neonatal-specific algorithms could enhance drug safety evaluations, strengthen evidence-based decision-making, and improve risk–benefit assessments in neonates and infants.

Background/Objectives: Recent public and scientific discussions have raised concerns about a possible link between prenatal paracetamol exposure and autism spectrum disorder (ASD). However, pharmacovigilance-based evidence remains scarce, and the role of reporting bias has not been systematically assessed. This study aimed to characterize ASD-related adverse event reports involving paracetamol in the U.S. Food and Drug Administration’s Adverse Event Reporting System (FAERS) and to evaluate potential disproportionality signals, considering demographic, temporal, and geographic patterns. Methods: FAERS data from January 2010 to September 2025 were screened for reports listing paracetamol as the suspect drug and ASD-related Preferred Terms. After excluding duplicates and concomitant drugs, 1776 unique cases were analyzed. Patient demographics, reporter type, and country of origin were summarized descriptively. Disproportionality was calculated using four algorithms: Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Information Component (IC), and Empirical Bayes Geometric Mean (EBGM). Results: Among 172,129 paracetamol-associated reports, 1776 (1.03%) included ASD-related terms. All were classified as serious and mostly submitted by consumers (98.6%). Gender was available in 47.7% of cases, showing male predominance (68.8%). Most reports referred to fetal exposure during pregnancy. Nearly all originated from the United States (98.4%). A marked rise was observed after 2022, with 562 reports in 2023 and 1051 in 2025. Disproportionality analyses revealed consistently elevated signals (ROR = 69.8, PRR = 69.2, IC025 = 5.60, EB05 = 48.3). Conclusions: The strong disproportionality signal likely reflects increased public attention and reporting dynamics rather than a causal association. Further integration of pharmacovigilance and epidemiologic data is warranted to clarify the clinical significance of these findings.

Background: While breastfeeding is highly recommended, breastfed infants may be exposed to drugs by milk due to the mother’s medication, with a risk of adverse drug events (ADE) or reactions (ADRs). The U.S. Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) is an online pharmacovigilance database, while the Drugs and Lactation Database (LactMed®) includes information on the levels of such substances in breast milk and infant blood, and the possible adverse effects in the nursing infants. Methods: The FAERS database was explored (July 29, 2024) on ADEs related to exposure during lactation, while annual trends, outcomes, and region of reporting were determined. Active pharmaceutical ingredients (API) were categorized based on Anatomical Therapeutic Chemical (ATC) classification. The top 5 APIs in each first level of ATC system were explored on ADEs reported and compared to LactMed®. Results: 2628 ADEs were obtained from the FAERS database, with increased reporting over time, while most ADEs were from North America (44.9%). Most drugs (50.9%) were nervous system drugs. The most frequent outcome was "other outcomes" (58.2%). 84,7% of the cases were categorized as serious. Related to the same drug, the FAERS database and LactMed® exhibited similarities and differences in adverse events, possibly due to factors such as maternal and neonatal pharmacokinetics (PKs), maternal therapy and infant exposure durations, milk production, and infant’s daily milk volume intake or causality assessment. Conclusions: ADE reporting systems are useful for obtaining information about medication related ADEs during lactation to increase knowledge on medication safety and awareness for possible risks in infants. The FAERS should be perceived a useful tool to detect ADEs, be it without ADR assessment.

Melasma is a chronic condition that leads to the buildup of melanin pigment in the epidermis and dermis due to active melanocytes. Even though it is considered a non-life-threatening condition, pigment disorders have a negative impact on quality of life. Since melasma treatment is not sufficient and complicated, new treatment options are sought. Research on metformin and ascorbic acid suggested that they might be used against melasma in the scope of “drug repositioning.”The MNT-1 human melanoma cell line was used to assess the effects of metformin, ascorbic acid, and metformin+ascorbic acid combination on cytotoxicity and oxidative stress. Melanin, cAMP, L-3,4-dihydroxyphenylalanine (L-DOPA) and tyrosinase levels were determined by commercial ELISA kits and tyrosinase gene expression was analyzed with RT-qPCR. Cytopathological evaluations were performed by phase contrast microscopy. Tyrosinase expression was determined by immunofluorescence (IF) staining of MNT-1 cells. The online service TargetNet was used for biological target screening. The parameters were not significantly altered by ascorbic acid applied at non-cytotoxic concentrations. On the contrary, metformin dramatically raised tyrosinase and intracellular ROS levels. Moreover, intracellular ROS levels and tyrosinase levels were found to be considerably elevated with the combined treatment. Also, potential metformin and ascorbic acid interactions were determined. According to the results, it can be said that these parameters were not significantly altered by ascorbic acid. On the contrary, metformin dramatically raised tyrosinase and intracellular oxidative stress levels. Moreover, intracellular oxidative stress and tyrosinase levels were elevated with the combined treatment. In conclusion, individual treatments of ascorbic acid or metformin may only provide a limited effect when treating melasma and extensive in vitro and in vivo research are required.

This study assessed bisphenol exposure in preterm infants (born before 35 weeks of gestation) hospitalized in a neonatal intensive care unit (NICU), along