Review Article: The Management of Heartburn in Pregnancy

Safety of Medical Treatments for GERD During Lactation

The heartburn of pregnancy typically resolves shortly after delivery, although some women still experience symptoms postpartum requiring treatment. All systemic antireflux medications are excreted in breast milk and could harm the infant. Therapeutic options must be explained and discussed with women who require treatment but who want to breastfeed.

Drug safety during lactation has been assessed in animal studies and human case reports ( Table 3 ). Aluminium and magnesium hydroxide antacids are not concentrated in breast milk and, thus, are safe during lactation. Neither Gaviscon nor sucralfate have been studied during lactation, but are presumed safe because of limited maternal absorption.

All H₂RAs are excreted in human breast milk. Cimetidine and ranitidine reach concentrations in breast milk four to seven times the doses present in maternal serum.^[41] In contrast, famotidine only reaches a mean milk:plasma concentration of 1.78, 6 h after ingestions.^[42] Small amounts of nizatidine are excreted into human breast milk.^[43] In the only animal studies assessing H₂RA safety during lactation, pups reared by lactating rats ingesting nizatidine experienced growth retardation.^[44] The effects of H₂RAs in breast milk on the nursing human infant are unknown. In 1994, the American Academy of Pediatrics classified cimetidine as compatible with breast feeding.^[45] The present review also suggests that ranitidine and famotidine are safe and the latter H₂RA may be preferred because of the lower concentration in human breast milk. Nizatidine should be avoided in the breast feeding mother because of the single animal study.^[44]

Little is known about PPI excretion in breast milk or infant safety in lactating women. PPIs probably are excreted in human milk, because of their relatively low-molecular weight. This was confirmed in the only report of PPI use during breast feeding.^[46] During the day, the patient fed her infant son just before taking omeprazole at 8:00 AM, refraining from nursing for 4 h, and then expressed and discarded her breast milk at noon. At 3 weeks postpartum, blood and milk samples were obtained at 8:00 AM, and then every 30 min for 4 h. Breast milk levels of omeprazole began to rise at 9:30 AM and peaked at 11:00 AM at 58 mM, considerably lower value than simultaneous maternal level of 950 mM. The infant was doing well at 1 year. However, rats administered omeprazole at 35-345 times and rabenprazole at a dose of 195 times the recommended human dose during late pregnancy and lactation had decreased body weight gain of their pups.^[33,47] Therefore, PPIs are not recommended for use by lactating mothers. Women with severe GERD symptoms can either take PPIs and discontinue nursing or use a GERD medication (i.e. H₂RA) from another class.

Cite this: Review Article: The Management of Heartburn in Pregnancy - Medscape - Nov 01, 2005.

Table 1. FDA Classification of Drugs for Pregnancy
FDA classification	Definition
Category A	Well controlled studies in humans show no fetal risk
Category B	Animal studies show no risks, but human studies inadequate or animal studies show some risk not supported by human studies
Category C	Animal studies show risk but human studies are inadequate or lacking or no studies in humans or animals
Category D	Definite fetal abnormalities in human studies but potential benefits may outweigh the risks
Category X	Contraindicated in pregnancy, fetal abnormalities in animals or humans. Risks outweigh benefits

Table 1. FDA Classification of Drugs for Pregnancy
FDA classification	Definition
Category A	Well controlled studies in humans show no fetal risk
Category B	Animal studies show no risks, but human studies inadequate or animal studies show some risk not supported by human studies
Category C	Animal studies show risk but human studies are inadequate or lacking or no studies in humans or animals
Category D	Definite fetal abnormalities in human studies but potential benefits may outweigh the risks
Category X	Contraindicated in pregnancy, fetal abnormalities in animals or humans. Risks outweigh benefits

Table 2. FDA Classification of Drugs Used for Gastro-oesophageal Reflux Disease in Pregnancy
Drugs	FDA class	Comments
Antacids
Aluminium-, calcium- or magnesium-containing antacids	None	Most are safe for use during pregnancy and for aspiration prophylaxis during labour because of minimal absorption
Magnesium trisilicates	None	Avoid long-term, high-dose therapy in pregnancy
Sodium bicarbonate	None	Not safe for use in pregnancy as causes fluid overload and metabolic alkalosis
Mucosal protectant
Sucralfate	B	No teratogenicity in animals. Generally regarded as acceptable for human use because of minimal absorption
Histamine₂-receptor antagonist (H₂RA)
Cimetidine	B	A prospective, controlled study suggests acceptable for use in humans
Ranitidine	B	Same as above. Ranitidine is the only H₂RA whose efficacy during pregnancy has been established
Famotidine	B	Same as cimetidine, but paucity of safety data in humans
Nizatidine	B	Not recommended during pregnancy. In animals, spontaneous abortion, congenital malformations, low birth weight and fewer live births have been reported. Little data in humans
Promotility agents
Cisapride	C	Embryotoxic and fetotoxic in animals. Recent prospective controlled study in humans suggests acceptable in pregnancy, but drugs recently removed by FDA for fatal cardiac arrhythmias
Metoclopramide	B	No teratogeneic effects in animals or humans reported
Proton-pump inhibitors
Omeprazole	C	Embryotoxic and fetotoxic in animals. Case reports in human suggest similar concerns. Acceptable for use for aspiration prophylaxis in labour
Lansoprazole	B	No fetal teratogenicity or harm. Limited human pregnancy date Use is acceptable for aspiration prophylaxis during pregnancy
Rabeprazole	B	No fetal teratogenicity or harm. Limited human pregnancy date Use is acceptable for aspiration prophylaxis during pregnancy
Pantoprazole	B	No fetal teratogenicity or harm. Limited human pregnancy date Use is acceptable for aspiration prophylaxis during pregnancy
Esomeprazole	B	No fetal teratogenicity or harm. Limited human pregnancy date Use is acceptable for aspiration prophylaxis during pregnancy

Table 3. Safety of GERD Medications During Lactation
Drugs	Safety	Comments
Antacids	Yes	Not concentrated in breast milk
Sucralfate	Yes	Minimal, if any, excretion in breast milk
H₂RA
Cimetidine	Yes	American Academy of Pediatrics classified as compatible with breast feeding
Ranitidine	Yes	Excreted in breast milk in concentrations similar to cimetidine
Famotidine	Yes	Lowest concentrations in breast milk of all H₂RAs
Nizatidine	No	Growth depression in pups of lactating rats
Proton-pump inhibitors	No	Little known of excretion in breast milk. Growth depression in pups of lactating rats receiving omeprazole and rabeprazole

GERD, gastro-oesophageal reflux disease; H₂RA, histamine₂-receptor antagonist.

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Review Article: The Management of Heartburn in Pregnancy

Safety of Medical Treatments for GERD During Lactation

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