Mexitil and Pregnancy

Based on animal studies of Mexitil (mexiletine), a pregnancy Category C classification has been placed on the drug. This means that it may not be safe for pregnant women. Although this medication has not been adequately studied in pregnant women, animal studies have shown that Mexitil may increase the risk for miscarriages.

Can Pregnant Women Take Mexitil?

Mexitil® (mexiletine) is a prescription medication approved to treat certain types of abnormal heartbeats, known medically as arrhythmias. Based on animal studies, this drug may not be safe for use during pregnancy.

What Is Pregnancy Category C?

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. Mexitil is classified as a pregnancy Category C medication.
Pregnancy Category C is given to drugs that have not been studied in pregnant humans but do appear to cause harm to the fetus in animal studies. Also, medicines that have not been studied in any pregnant women or animals are automatically given a pregnancy Category C rating.
In animal studies, doses up to four times the maximum human Mexitil dosage were given to pregnant rats and mice. In these studies, the drug did not increase the risk for birth defects. However, it did cause an increase in miscarriage.
Mexitil has not been adequately studied in pregnant women. There have been three reported cases of women who took the medication at some point during pregnancy -- one throughout pregnancy, one from week 14 on, and one from week 32 on. No problems were reported in any of the infants.
It is important to note, however, that animals do not always respond to medicines in the same way that humans do. Therefore, a pregnancy Category C medicine, including Mexitil, may be given to a pregnant woman if her healthcare provider believes that the benefits to the woman outweigh any possible risks to her unborn child.
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Mexitil Medication Information

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