From the Guidelines
Bisoprolol and digoxin should generally be avoided during pregnancy unless the potential benefits clearly outweigh the risks. Bisoprolol (a beta-blocker) is typically classified as pregnancy category C, meaning animal studies have shown adverse effects on the fetus, and there are no adequate studies in pregnant women. It may be associated with fetal growth restriction, bradycardia, and hypoglycemia, particularly when used in the third trimester. Digoxin has a slightly better safety profile (pregnancy category C), with longer historical use in pregnancy, but still requires careful consideration. If treatment for cardiac conditions is absolutely necessary during pregnancy, alternative medications with better established safety profiles should be considered first. For heart failure or arrhythmias, medications like methyldopa or labetalol may be safer options for blood pressure control, while digoxin might be used with close monitoring if the maternal benefit justifies the potential risk. Any woman taking these medications who becomes pregnant should consult her healthcare provider immediately to discuss the risks and benefits of continuing treatment versus switching to alternatives. Throughout pregnancy, close maternal and fetal monitoring is essential, including regular ultrasounds to assess fetal growth and heart rate if these medications must be continued, as recommended by the 2024 AHA/ACC/AMSSM/HRS/PACES/SCMR guideline for the management of hypertrophic cardiomyopathy 1.
Some key points to consider when managing pregnant women with cardiovascular disease include:
- Most beta blockers, such as metoprolol, bisoprolol, labetalol, pindolol, and propranolol, are generally considered safe to use during pregnancy, but atenolol has some evidence of potential fetal risk 1.
- The use of anticoagulation therapy, such as low-molecular-weight heparin or low-dose warfarin, may be necessary in some cases, but the risks and benefits must be carefully weighed, as suggested by the 2020 ACC/AHA valvular heart disease guideline 1.
- A multidisciplinary care team that includes cardiologists and maternal-fetal medicine specialists can provide comprehensive management of pregnant women with cardiovascular disease, as recommended by the 2024 AHA/ACC/AMSSM/HRS/PACES/SCMR guideline for the management of hypertrophic cardiomyopathy 1.
- The European Society of Cardiology (ESC) guidelines on the management of cardiovascular diseases during pregnancy also provide recommendations for the use of various medications during pregnancy, including beta blockers and digoxin 2.
- The 2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APHA/ASH/ASPC/NMA/PCNA guideline for the prevention, detection, evaluation, and management of high blood pressure in adults provides recommendations for the treatment of hypertension during pregnancy, including the use of methyldopa, nifedipine, and labetalol 3, 4.
- The ACC/AHA/ESC guidelines for the management of patients with supraventricular arrhythmias provide recommendations for the treatment of supraventricular tachycardia during pregnancy, including the use of vagal maneuvers, adenosine, and beta blockers 5.
In summary, the use of bisoprolol and digoxin during pregnancy should be carefully considered, and alternative medications with better established safety profiles should be used whenever possible. Close maternal and fetal monitoring is essential to minimize the risks associated with these medications.
From the FDA Drug Label
Bisoprolol fumarate was not teratogenic at doses up to 150 mg/kg/day which is 375 and 77 times the MRHD on the basis of body weight and body surface area, respectively. Bisoprolol fumarate was fetotoxic (increased late resorptions) at 50 mg/kg/day and maternotoxic (decreased food intake and body weight gain) at 150 mg/kg/day There are no adequate and well-controlled studies in pregnant women. Bisoprolol fumarate should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Pregnancy Category C. Animal reproduction studies have not been conducted with digoxin It is also not known whether digoxin can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Digoxin should be given to a pregnant woman only if clearly needed.
Pregnancy and Lactation
- Bisoprolol and digoxin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus [6] [7].
- There are no adequate and well-controlled studies in pregnant women for both bisoprolol and digoxin.
- Bisoprolol fumarate was fetotoxic at 50 mg/kg/day and maternotoxic at 150 mg/kg/day in animal studies 6.
- Digoxin should be given to a pregnant woman only if clearly needed 7.
- Caution should be exercised when bisoprolol and digoxin are administered to nursing women [6] [7].
From the Research
Bisoprolol and Digoxin in Pregnancy
- There is limited information available on the use of bisoprolol and digoxin during pregnancy.
- A study published in 2020 8 compared the effects of digoxin and bisoprolol on heart rate control in patients with atrial fibrillation, but it did not specifically address pregnancy.
- Another study from 2019 9 discussed switching between β-blockers, including bisoprolol, but did not provide guidance on their use during pregnancy.
- A systematic review from 2022 10 analyzed the use of bisoprolol for treating arrhythmias, but it did not include information on pregnancy.
Use of Bisoprolol and Digoxin in Atrial Fibrillation
- Bisoprolol and digoxin are used to control heart rate in patients with atrial fibrillation 11, 8.
- A study from 2002 11 found that beta-blockers, including bisoprolol, are effective in maintaining sinus rhythm and controlling ventricular rate during atrial fibrillation.
- The 2020 study 8 found that digoxin and bisoprolol had similar effects on quality of life and heart rate control in patients with permanent atrial fibrillation.