Table 2.
Safety of drugs used in pregnancy-associated liver diseases
| Drug | FDA pregnancy category | Comments |
| Antiemetics | ||
| Promethazine | C | Possible respiratory depression if drug is administered near time of delivery |
| Metoclopramide | B | Available evidence suggests safe use during pregnancy |
| Ondansetron | B | Additional studies are needed to determine safety to the fetus, particularly during the first trimester |
| Prochlorperazine | C | There are isolated reports of congenital anomalies; however, some included exposures to other drugs. Jaundice, extrapyramidal signs, hyper-/hyporeflexes have been noted in newborns |
| Antihypertensives | ||
| ACE inhibitors | C/D | First trimester exposure to ACE inhibitors may cause major congenital malformations |
| Second and third trimester use of an ACE inhibitor is associated with oligohydramnios and anuria, hypotension, renal failure, skull hypoplasia, and death in the fetus/neonate | ||
| Beta blockers | C/D | Fetal bradycardia, hypotension, risk of intrauterine growth retardation |
| Calcium channel blockers | C | Teratogenic and embryotoxic effects have been demonstrated in small animals. There are no adequate and well-controlled studies in pregnant women |
| Anticoagulation | ||
| Aspirin | C (1st/2nd trimesters) D (3rd trimester) | Adverse effects in the fetus include intrauterine growth retardation, salicylate intoxication, bleeding abnormalities, and neonatal acidosis. Use of aspirin close to delivery may cause premature closure of the ductus arteriosus. Data have shown low-dose aspirin (60-150 mg/day) may be safe in pregnancy |
| Enoxaparin | B | No adequate and well-controlled studies using enoxaparin. Postmarketing reports include congenital abnormalities and also fetal death |
| Heparin | C | Does not cross the placenta |
| Intrahepatic cholestasis | ||
| Ursodeoxycholic acid | B | Relatively low risk |
| S-adenosyl-L-methionine | Not evaluated by FDA | Relatively low risk |
| Cholestyramine | C | Cholestyramine is not absorbed systemically, but may interfere with vitamin absorption |
United States Food and Drug Administration (FDA) pregnancy categories: Category A: Well-controlled studies failed to show a risk to the fetus in the first trimester of pregnancy (and there is no evidence of risk in the second or third trimesters). Category B: Animal reproduction studies failed to show a risk to the fetus, and there are no adequate studies in pregnant women. Category C: Animal reproduction studies have shown an adverse effect on the fetus. There are no adequate studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks. Category D: There is evidence of human fetal risk based on data from investigational or marketing experience or studies in humans. However, the potential benefits may warrant use of the drug in pregnant women despite potential risks. Category X: Data have demonstrated fetal abnormalities in animals and humans, and/or there is positive evidence of human fetal risk based on data from investigational or marketing experience. The risks of the use of the drug in pregnant women outweigh potential benefits.