Peganone and Pregnancy

Women may not be able to safely take Peganone (ethotoin) during pregnancy, as this drug may harm the fetus. As a pregnancy Category D medication, Peganone may cause birth defects or other potentially serious problems. To avoid dangerous complications, talk to your healthcare provider about whether the benefits of taking this drug outweigh the potential risks to the unborn child.

Can Pregnant Women Take Peganone?

Peganone® (ethotoin) is a prescription medication used to control seizures in people with epilepsy. Due to a few cases of problems, as well as the drug's similarity to another seizure medication that can cause birth defects, it is thought that this medication may not be safe for use during pregnancy.

What Is Pregnancy Category D?

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. Peganone is classified as a pregnancy Category D medicine.
Pregnancy Category D is a classification given to medicines that have been shown to present a risk to the fetus in studies of pregnant women, but may still offer benefits that outweigh the risks the drug presents. A pregnancy Category D drug may still be given to a pregnant woman if the healthcare provider believes that the benefits to the woman outweigh the possible risks to the unborn child.

What Risks Does Peganone Present to a Pregnant Woman?

There is very little information available about the use of Peganone during pregnancy. A few cases of birth defects have been reported, but there is not enough information to determine if the birth defects were related to Peganone.
Of more concern, Peganone is related to phenytoin (a much more commonly used seizure medication), and it is reasonable to assume that Peganone might cause the same pregnancy-related problems. Several studies have shown that phenytoin may cause birth defects in humans. Sometimes, these birth defects can be quite severe.
However, uncontrolled epilepsy can also be dangerous to both a pregnant woman and the fetus. You and your healthcare provider must discuss the specific benefits and risks of using Peganone during pregnancy in your particular situation.
If your epilepsy is mild, or if you have not had a seizure in several years, your healthcare provider may consider recommending that you stop Peganone. However, if your epilepsy is severe or difficult to control, it may be best for you to keep taking this medication. No matter what, do not stop taking Peganone suddenly or without your healthcare provider's approval.
If you and your healthcare provider decide that it is best for you to continue taking Peganone, you will need frequent blood tests to measure your Peganone levels. Pregnancy can affect the way your body handles this medicine, and it is important to keep your dose at the lowest effective level to help protect your fetus.
Based on what is known about phenytoin, your healthcare provider may suggest a higher-than-normal dose of folic acid, as this may also help protect the fetus. Also, you may need to take vitamin K during the last part of your pregnancy to protect your baby from a vitamin K deficiency.
Pregnancy and Pain

Peganone Medication Information

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