Vimpat and Pregnancy
The FDA has classified Vimpat (lacosamide) as a pregnancy Category C medication, meaning the medicine may not be safe for use during pregnancy. Animal studies showed that the medication may increase the risk of fetal death, decrease fetal weight, or cause long-term neurological issues. Therefore, if pregnancy occurs while you are taking Vimpat, your healthcare provider will consider the benefits and risks before making a recommendation.
Is Vimpat Safe for Pregnant Women?Vimpat® (lacosamide) is a prescription medication approved to treat partial-onset seizures. Based on the results of animal studies, Vimpat may not be safe for use in pregnant women.
Pregnancy Category CThe U.S. Food and Drug Administration (FDA) uses a pregnancy 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 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.
When given to pregnant rats in pregnancy and while breastfeeding, high doses of Vimpat caused the following problems:
- Increased risk of fetal or newborn death
- Decreased weight in the offspring
- Decreased brain weight in the offspring
- Long-term neurological or behavioral issues (such as learning or memory problems).
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 may be given to a pregnant woman if the healthcare provider believes that the benefits to the pregnant woman outweigh any possible risks to the unborn child. It is important to understand that uncontrolled seizures can be dangerous to a developing fetus.
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 (or lack of problems) seen during this time. Doing so may help other pregnant women make a decision about Vimpat and whether they want to take it in the future.