Is Carafate (sucralfate) safe in a pregnant patient with hyperemesis gravidarum?

Is Carafate (Sucralfate) Safe in Pregnant Patients with Hyperemesis Gravidarum?

Sucralfate is safe to use during pregnancy, including in patients with hyperemesis gravidarum, as it is classified as FDA Pregnancy Category B with no evidence of fetal harm in animal studies, though it is not a standard treatment for hyperemesis gravidarum itself. 1

Safety Profile in Pregnancy

• Sucralfate has been studied in mice, rats, and rabbits at doses up to 50 times the human dose with no evidence of teratogenicity or harm to the fetus. 1
• The FDA classifies sucralfate as Pregnancy Category B, meaning animal reproduction studies have failed to demonstrate fetal risk, though adequate well-controlled studies in pregnant women are lacking. 1
• Because animal studies are not always predictive of human response, sucralfate should be used during pregnancy only if clearly needed. 1

Mechanism and Absorption Considerations

• When administered orally, only small amounts of aluminum are absorbed from the gastrointestinal tract, which is adequately excreted by patients with normal renal function. 1
• The primary mechanism of sucralfate is local (nonsystemic), forming a protective barrier over ulcerated tissue in the gastrointestinal tract. 1
• Sucralfate can bind to other medications in the GI tract and reduce their absorption, so it should be administered separately from other drugs—particularly critical medications should be given 2 hours before sucralfate. 1

Specific Considerations for Hyperemesis Gravidarum

• Sucralfate is not mentioned in current hyperemesis gravidarum treatment guidelines as a standard therapy. 2
• The established treatment algorithm for hyperemesis gravidarum prioritizes: first-line antiemetics (doxylamine-pyridoxine, antihistamines like promethazine or cyclizine), second-line agents (metoclopramide, ondansetron), and third-line corticosteroids for refractory cases. 2
• If sucralfate is being considered for gastric protection or reflux symptoms in a patient with hyperemesis gravidarum, it can be safely used, but timing of administration is critical to avoid interfering with absorption of essential antiemetics and thiamine supplementation. 1

Critical Drug Interaction Warning

• Patients with hyperemesis gravidarum require thiamine 200-300 mg IV daily (or 300 mg orally if tolerated) to prevent Wernicke's encephalopathy—sucralfate could theoretically reduce thiamine absorption if given simultaneously. 2, 1
• Thiamine deficiency can develop rapidly in hyperemesis gravidarum, with stores potentially exhausted after only 20 days of inadequate oral intake. 2
• Administer thiamine and other critical medications at least 2 hours before sucralfate to ensure adequate absorption. 1

Practical Recommendations

• If the patient has gastritis, peptic ulcer disease, or severe reflux complicating hyperemesis gravidarum, sucralfate can be safely prescribed during pregnancy. 1
• Ensure the patient can swallow tablets safely, as sucralfate should be used with caution in patients with dysphagia, recent intubation, or conditions impairing swallowing—relevant given the severity of vomiting in hyperemesis gravidarum. 1
• Monitor for adequate absorption of other essential medications by spacing administration appropriately, particularly antiemetics, thyroid medications if applicable, and vitamin supplementation. 1

Lactation Considerations

• It is unknown whether sucralfate is excreted in human milk, so caution should be exercised when administering to nursing women. 1