Sabril and Pregnancy
As a pregnancy Category C medication, Sabril (vigabatrin) may not be safe for use in women who are expecting. When given to pregnant animals, this drug appeared to cause birth defects, seizures in the offspring, and other problems. Although this medication is used as a "last resort" seizure medication, there may be times when the benefits outweigh the possible risks to the unborn child.
Can Pregnant Women Take Sabril?Sabril® (vigabatrin) is a prescription medication approved to treat certain types of very serious or difficult-to-control seizures. Based on the results of animal studies, Sabril may not be safe for use in pregnant women.
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. Sabril is classified as a pregnancy Category C medication.
Pregnancy Category C is given to medicines that have not been studied in pregnant humans but do appear to cause fetal harm in animal studies. Also, medicines that have not been studied in any pregnant women or animals are automatically given a pregnancy Category C rating.
When given to pregnant animals, Sabril caused the following problems:
- Birth defects
- Embryo or fetal death
- Low fetal weight
- Seizures in the offspring
- Various neurological or behavioral problems in the offspring.
However, it is important to note that animals do not always respond to medicines in the same way that humans do. Therefore, a pregnancy Category C medicine, including Sabril, may be given to a pregnant woman if her healthcare provider believes that the benefits to the woman outweigh any possible risks to the unborn child.
It is important to understand that uncontrolled seizures can be dangerous to a developing fetus. It is also important to understand that Sabril is usually not prescribed unless several other medications have already been tried and failed; Sabril is generally used as a "last resort" medication, due to the high risk of permanent vision loss.
If you and your healthcare provider decide that you should take this drug during pregnancy, you can choose to have your healthcare provider report your case to a special registry created to keep track of problems that might occur with using Sabril during pregnancy. Doing so may help other women decide whether to take Sabril during pregnancy in the future.