TABLE 1.
Key effects of common medications used in cirrhosis during pregnancy
| Drug | FDA categorya | Possible effects on foetus | Presence human milk (levels) | Breastfeeding effects on infant |
|---|---|---|---|---|
| Variceal management | ||||
| Propranolol | C | IUGR, bradycardia, hypoglycaemia | Yes (low) | Unlikely to cause harm: monitor for signs of β‐blockade, avoid feeds for >3 hours after dosage |
| Carvedilol | C | Hypotension, bradycardia, hypoglycaemia, respiratory issues | Yes | NK: can use if benefits outweigh potential risks |
| Octreotide | B | IUGR, sporadic reports of spontaneous abortion in first trimester | NK | NK: can use if benefits outweigh potential risks |
| Terlipressin | NA | Malformations (animal studies), spontaneous abortion Drug not recommended during pregnancy | NK | NK: can use if benefits outweigh potential risks |
| Diuretics | ||||
| Spironolactone | C | Foetal demise (animal studies), pro‐gestational and anti‐androgenic effects, hypovolaemia | Yes | NK: can use if benefits outweigh potential risks |
| Furosemide | C | Foetal demise (animal studies), hypovolaemia, electrolyte disturbances | Yes | NK: can use if benefits outweigh potential risks |
| Hepatic encephalopathy | ||||
| Rifaximin | C | Teratogenicity: cleft palate, agnathia, jaw shortening, brachygnathia, incomplete ossification (animal studies) | NK | NK: can use if benefits outweighpotential risks |
| Lactulose | B | No evidence of harm | NK | NK: can use if benefits outweigh potential risks |
| Immunosuppression | ||||
| Prednisolone | C/D | Cleft lip ± palate, cataracts, adrenal suppression and LBW | Yes | Disturbed growth/adrenal sup‐ pression: use lowest dose, avoid feeds for >4 hours after dose+ |
| Azathioprine | D | Spontaneous abortion, prematurity, LBW/IUGR Leucopaenia, thrombocytopaenia, hypogammaglobulinaemia, thymic hypoplasia (reversibility after birth) In practice, if established on drug, can continue in pregnancy | Yes (low/undetectable) | Mild neutropaenia and potentiallong‐term carcinogenesis effects: avoid feeds for 4–6 hours after dosage+ |
| Mercaptopurine | D | Spontaneous abortion, prematurity, congenital anomalies In practice, if established on drug, can continue in pregnancy | NK | NK: can use if benefits outweigh potential risks |
| Mycophenolate mofetil | D | Early pregnancy loss, congenital malformations (ear/facial abnormalities, cleft lip, anomalies of distal limbs, etc.) | NK | NK: can use if benefits outweigh potential risks |
| Cyclosporine | C | Prematurity/LBW Immunosuppressive effects | NK (variable) | NK (? immunosuppression/carcinogenesis): contraindicated by AAP, monitor for toxicity |
| Tacrolimus | C | Spontaneous abortion, foetal death, prematurity, LBW Birth defects and congenital anomalies Transient neonatal hypercalcaemia (no long‐term sequelae) In practice, if established on drug, can continue in pregnancy | Yes (low) | Not expected to cause adverse effects: breastfed infants should be monitored for toxicity |
| Cholestatic therapies | ||||
| UDCA | B | Foetal demise and teratogenicity (animal studies) In practice, it is widely used without adverse effects | NK | NK: can use if benefits outweigh potential risks |
| Cholestyramine | C | No reported animal studies In practice, it is widely used without adverse effects | NK (unlikely) | Considered acceptable, caution recommended |
| Naltrexone | C | Early foetal loss (high doses), no teratogenicity (animal studies) | Yes | NK (? carcinogenesis): can use if benefits outweigh potential risks |
| Rifampicin | C | Congenital malformations, cleft palate and imperfect osteo‐ genesis (animal studies) Inhibition of vitamin K production in mother→supplementation | Yes | NK (? carcinogenesis): AAP/WHO classify drug as compatible with breastfeeding |
Category A: adequate and well‐controlled studies have failed to demonstrate foetal risk in the first and later trimesters of pregnancy. Category B: animal reproduction studies have failed to demonstrate foetal risk and there are no adequate well‐controlled studies in pregnant women.
Category C: Animal reproduction studies have shown an adverse effect on the foetus, but there are no adequate well‐controlled studies in humans. So, potential benefits may warrant use of the drug in pregnant women, despite potential risks.
Category D: positive evidence of human foetal risk based on adverse reaction data from investigational/marketing experience or human studies, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
NA: not assigned, insufficient data exist regarding this drug in pregnant women to determine the risk of adverse outcomes.
Abbreviations: AAP, American Academy of Pediatrics; FDA, Food and Drug Administration; IUGR, intrauterine growth restriction; NK, not known; LBW, low birth weight; UCDA, ursodeoxycholic acid; WHO, World Health Organization.