Heart Home > Sotalol and Pregnancy

Based on the results of animal studies on sotalol and pregnancy, the medication does not appear to pose a significant risk to a developing fetus. Since the drug crosses the placenta, it has been used to treat arrhythmias in fetuses. If you are taking sotalol and pregnancy occurs, your healthcare provider will weigh the benefits and potential risks before making a recommendation for your situation.

Can I Take Sotalol When Pregnant?

Sotalol (Betapace®, Sorine®) is a prescription beta blocker medication approved to treat certain irregular heart rhythms (arrhythmias). Based on the results of animal studies and limited experience with the drug in pregnant women, sotalol does not seem to pose a significant risk to a developing fetus, although the full risks are currently unknown.
 

Sotalol and Pregnancy Category B

The U.S. Food and Drug Administration (FDA) uses a category system to classify the possible risks to a fetus when a specific medicine is taken during pregnancy. Pregnancy Category B is given to medicines that have not been adequately studied in pregnant humans but that do not appear to cause harm to the fetus in animal studies. Medications that have been shown to be safe for use during pregnancy in humans, even though they have caused problems in laboratory animals, are also given a Category B rating.
 
When given to pregnant rats and rabbits, very high doses of sotalol increased the risk of miscarriages. It did not appear to cause any birth defects.
 
However, it is important to note that animals do not always respond to medicines the same way that humans do. Therefore, a pregnancy Category B medicine should be given to a pregnant woman only if the healthcare provider believes that the benefits to the woman outweigh any possible risks to the unborn child.
 
Because the medication crosses the placenta, sotalol has been used to treat arrhythmias in the fetus, sometimes with success, sometimes not.
 
Written by/reviewed by:
Last reviewed by: Kristi Monson, PharmD;
Last updated/reviewed:
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