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Medications Used for Gastroesophageal Reflux and Peptic Ulcer Disease Drug FDA category Recommendations for pregnancy Recommendations for breastfeeding Antacids Aluminum-containing antacids Calcium-containing antacids Magnesium-containing antacids Magnesium trisilicates Sodium bicarbonate None None None None None Most safe: minimal absorption Most safe: minimal absorption Most safe: minimal absorption Avoid long-term use or high doses Not safe: alkalosis Low risk Low risk Low risk Low risk Low risk Mucosal protectants Sucralfate B Safe No human data: probably compatible Histamine receptor antagonists Cimetidine Famotidine Nizatidine B B B Compatible Limited human data: probably compatible Limited human data: probably compatible B Controlled data: low risk Paucity of safety data Limited human data (low risk in animals) Low risk Proton pump inhibitors Dexlansoprazole Esomeprazole Lansoprazole Omeprazole Pantoprazole Rabeprazole B B B C B B Limited data: low risk Limited data: low risk Limited data: low risk Embryonic and fetal toxicity Limited data: low risk Limited data: low risk No human data: potential toxicity No human data: potential toxicity No human data: potential toxicity Limited human data: potential toxicity No human data: potential toxicity No human data: potential toxicity Promotility agents Cisapride C Limited human data: probably compatible Metoclopromide B Controlled study: low risk, limited availability Low risk Safe Not safe: teratogenicity Avoid in first trimester Low risk: avoid in first trimester Not safe: teratogenicity Compatible No human data: potential toxicity No human data: probably compatible Limited human data: potential toxicity Compatible Ranitidine Treatment of Helicobacter pylori infection Amoxicillin B Bismuth C Clarithromycin C Metronidazole B Tetracycline D Limited human data: probably compatible Limited human data: potential toxicity Abbreviation: FDA, US Food and Drug Administration

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In contrast, in underdeveloped countries with poor public health infrastructure, the incidence of EF is estimated to be approximately 100 cases per 100,000 people annually (Kim et al., 2022

The study team was kept blinded to the results of the interim analysis and the data monitoring committee recommended pursuing the study as originally planned, i.e., without further inflation of the sample size