Potiga and Pregnancy
If you are pregnant, it's important to be aware of the risks associated with Potiga (ezogabine). When this medicine was given to animals that were pregnant or breastfeeding, it caused skeletal problems, low birth weights, and other problems. Due to the potential risks, women should only take this drug during pregnancy if the benefits outweigh the risks.
Can Pregnant Women Take Potiga?Potiga™ (ezogabine) is a prescription medicine approved to treat partial-onset seizures. Based on the results of animal studies, Potiga may not be safe for use in pregnant women.
What Is Pregnancy Category C?Potiga is classified as a pregnancy Category C drug. 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 C is given to medicines that have not been adequately studied in pregnant humans but have caused fetal harm in animal studies.
In addition, medicines that have not been studied in any pregnant women or animals are automatically given a pregnancy Category C rating.
When given to pregnant and lactating animals, Potiga caused the following problems:
- Skeletal variations (abnormal, but not necessarily serious, bone changes)
- An increased risk for fetal or newborn death
- Decreased weight in the offspring
- Delayed reflex development.
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 Potiga, may be given to a pregnant woman if the healthcare provider believes that the benefits to the mother outweigh any possible risks to her unborn child. However, it is important to understand that uncontrolled seizures can also be dangerous to a developing fetus.
If you and your healthcare provider decide that you should take Potiga during pregnancy, you can choose to have your healthcare provider report your case to a special registry created to keep track of problems (or lack of problems). Doing so may help other women decide whether to take Potiga during pregnancy in the future.