Is sucralfate (sucralfate) safe to use during pregnancy?

Sucralfate Safety in Pregnancy

Sucralfate is safe to use during pregnancy and should be considered first-line therapy for gastroesophageal reflux disease and peptic ulcer symptoms in pregnant women. 1

FDA Classification and Safety Profile

• Sucralfate is classified as FDA Pregnancy Category B, meaning animal reproduction studies at doses up to 50 times the human dose have revealed no evidence of harm to the fetus in mice, rats, and rabbits 1
• No adequate and well-controlled studies exist in pregnant women, but the extensive animal safety data and clinical experience support its use when clearly needed 1
• Sucralfate has minimal systemic absorption (only small amounts of aluminum are absorbed from the gastrointestinal tract), which contributes to its favorable safety profile 1

Clinical Recommendations for Use

Sucralfate is recommended as first-line medical therapy for GERD during pregnancy, either alone or in combination with antacids and alginic acid 2, 3, 4

• Begin with lifestyle modifications and dietary changes, then add sucralfate if symptoms persist 2
• Sucralfate is particularly valuable during pregnancy because it is one of the safest therapeutic choices for acid-related diseases, with a "quite complete lack of side effects" 5
• The drug works by forming a physical barrier at the ulcer site, protecting against pepsin, acid, and bile salts without significant systemic effects 5, 6

Dosing and Administration

• Standard dosing is 1g four times daily for active ulcer disease 6
• Sucralfate should be administered separately from other medications (typically 2 hours apart) because it can bind to other drugs in the gastrointestinal tract and reduce their absorption 1
• Monitor patients taking warfarin, digoxin, fluoroquinolones, thyroid hormone, or phenytoin for potential interactions requiring dose separation 1

Special Considerations

Caution is warranted in pregnant patients with chronic renal failure, as aluminum accumulation can occur in those with impaired renal function 1

• Patients with normal renal function adequately excrete absorbed aluminum in urine 1
• Avoid concomitant use with aluminum-containing antacids in patients with renal impairment to prevent increased aluminum body burden 1
• The most common side effect is constipation, occurring in only 2% of patients 6

Lactation Safety

• It is unknown whether sucralfate is excreted in human milk, so caution should be exercised during breastfeeding 1
• However, sucralfate is preferred during lactation due to minimal systemic absorption 3
• Drugs with minimum systemic absorption like sucralfate and alginic acid are preferable choices for GERD during the lactation period 3

Treatment Algorithm for GERD in Pregnancy

1. First step: Lifestyle modifications and dietary changes 2
2. Second step: Add sucralfate or antacids/alginic acid as first-line medical therapy 2, 4
3. Third step: If symptoms persist, consider H2-receptor antagonists (ranitidine preferred) 3, 4
4. Fourth step: Reserve proton pump inhibitors (except omeprazole) for intractable symptoms or complicated disease after the first trimester 2, 3