Review of recent evidence on the management of heartburn in pregnant and breastfeeding women

BMC Gastroenterology

Table 2 Safety of GERD therapies during pregnancy and lactation

Medications	US FDA classification according to foetal safety^a [12, 47, 67]	Pregnancy		Lactation
Medications		Safety	Comments	Safety	Comments
Antacids
Aluminium hydroxide	B	Yes, except for magnesium trisilicates and sodium bicarbonate	Care must be taken for use in pregnant women with nutrient deficiency	Yes, except for magnesium trisilicates and sodium bicarbonate	Not concentrated in breast milk [57]
Magnesium hydroxide	B
Calcium carbonate	C
Magnesium trisilicates	None
Sodium bicarbonate	C
Alginates	None	Yes	Likely safe due to limited maternal absorption	Yes	Likely safe due to limited maternal absorption
H₂RA
Cimetidine	B	Yes, except ranitidine	Any H₂RA may be used	Yes, except ranitidine	Famotidine is preferred
Ranitidine	B^b
Famotidine	B
Nizatidine	B
Mucosal protectant
Sucralfate	B	Yes	Likely safe due to limited maternal absorption	Yes	Minimal excretion in breast milk [57]
PPI
Omeprazole	C	Yes, except omeprazole	PPIs except omeprazole are considered appropriate if GERD is poorly controlled by other interventions	Yes, except omeprazole	Pantoprazole is preferred
Lansoprazole	B
Rabeprazole	B
Pantoprazole	B
Esomeprazole	B
P-CAB
Vonoprazan	None	Unknown	–	Unknown	–
Promotility agents
Metoclopramide^c	B	No	Long-term use is not recommended [78]	No	Long-term use is not recommended [78]

US FDA, United States Food and Drug Administration; GERD, gastroesophageal reflux disease; H₂RA, histamine-2 receptor antagonist; PPI, proton pump inhibitor; P-CAB, potassium-competitive acid blocker
^aThe US FDA classifies drugs according to foetal safety, as follows: Category A drugs as the safest category; Category B drugs are considered relatively safe; category C drugs are likely safe or negligibly harmful; category D drugs are potentially dangerous; and category X drugs are contraindicated during pregnancy
^bThe U.S. Food and Drug Administration has recently issued statement to request manufacturers withdraw all prescription and over-the-counter ranitidine drugs from the market, due to ongoing investigations on the possible higher-than-safe levels of a carcinogenic contaminant, N-nitrosodimethylamine (NDMA), in ranitidine products[47]
^cThe US FDA issued a black box warning for metoclopramide due to reports of tardive dyskinesia with high-dose, long-term use[61]

ISSN: 1471-230X