Table 17.
AADs during pregnancy and breastfeeding464
| Drug | Former FDA category | Placental transfer | Present in human milk | Safety in lactation | Adverse effects | Used for foetal arrhythmias |
|---|---|---|---|---|---|---|
| Adenosine | C | No | No | LD | No foetal adverse effects reported (limited human data) | Yes |
| Amiodarone | D | Yes | Yes | Contraindicated | Goitre, hypo- (9%), hyper-thyroidism, neurodevelopmental abnormalities, premature birth, growth retardation; bradycardia and QT prolongation in newborns | (Yes, last choice) |
| Atenolol | D | Yes | Yes | Produces IUGR Avoid its use |
Significant IUGR | |
| Atropine | C | LD | Yes | Yes | LD | |
| Bepridil | C | LD | Yes | Avoid its use | LD | |
| Bisoprolol, carvedilol, metoprolol, propranolol | C | Yes | Yes | LD | Foetal bradycardia and hypoglycaemia, IUGR and immature and preterm birth | Yes (metoprolol) |
| Cibenzoline | C | LD | In animals | LD | LD | |
| Digoxin | C | Yes | Yes | Considered safe | Serum levels unreliable, safe | Yes |
| Diltiazem | C | Yes | Yes | Avoid its use | Diltiazem is teratogenic in animals | |
| Disopyramide | C | Yes | Yes | Avoid its use | Uterine contractions, placental abruption, prolonged QT | |
| Dofetilide | C | In animals | LD | Avoid its use | Adverse effects in animals | |
| Dronedarone | X | Unknown | Contraindicated | It may cause foetal harm when administered to a pregnant woman Dronedarone is teratogenic in rats | ||
| Esmolol | C/Da | LD | Unknown | Avoid its use | See β-blockers | |
| Flecainide | C | Yes | Yes | Plasma levels in nursing infants are 5–10 times lower than therapeutic plasma levels | LD | Yes |
| Ibutilide | − | Unknown | Yes | Contraindicated | Teratogenic (abnormalities included adactyly, interventricular septal defects, and scoliosis) in rats | |
| Ivabradine b | LD | Yes (in rats) | Yes | Avoid its use | Animal reproduction studies have shown adverse effects | |
| Lidocaine | B | Yes | Yes | Considered safe | Foetal bradycardia/tachycardia, neonatal bradycardia, hypotonia or respiratory depression | Yes |
| Mexiletine | C | Yes | Yes | Caution | Limited data, but probably safe | |
| Nicorandil | B | LD | Yes in animals | LD | No harmful effects in animals | |
| Pilsicainide | C | LD | Yes in animals | LD | ||
| Procainamide | C | Yes | Yes | Avoid its use | Lupus-like syndrome, prolonged QT | |
| Propafenone | C | Yes | Unknown | LD | Limited data. Probably safe | Yes |
| Quinidine | C | Yes | Yes | Yes | Foetal/neonatal thrombocytopenia, uterine contraction, prolonged QT. | Yes |
| Ranolazine | LD | LD | Unknown | Avoid its use | Foetal bradycardia, hypoglycaemia, reduced birth-weight, QT prolongation | |
| Sotalol | B | Yes | Yes | Avoid its use | Maternal QTc prolongation | Yes |
| Verapamil | C | Yes | Yes | LD | Pre-maturity, IUGR, foetal bradycardia, impaired uterine contraction | |
| Vernakalant | Unknown | LD | Unknown | Unknown | LD |
AADs in bold are contraindicated or discouraged for use during pregnancy.
Pregnancy categories were formerly advised by the U.S. FDA:
- A: Controlled studies show no risk to the foetus.
- B: May be acceptable. Either animal studies showed no risk but human studies are not available, or animal studies showed minor risks and human studies showed no risk.
- C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies were not available or neither animal nor human studies were done.
- D: Use in life-threatening emergencies when no safer drug is available. Positive evidence of human foetal risk.
- X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
Abbreviations: IUGR, intrauterine growth retardation; FDA, Food and Drug Administration; LD, limited human data.
aD in the second and third trimesters.
bWomen of child-bearing potential must use appropriate contraceptive measures during treatment.