Is Trilipix Safe During Pregnancy?
Trilipix™ (
fenofibric acid delayed-release, also known as choline fibrate) is a pregnancy Category C medicine. This means that it may not be safe for use during pregnancy, although the full risks are currently unknown.
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. Pregnancy Category C is given to medicines that have not been studied in pregnant humans but that 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.
Trilipix has not been studied in pregnant women. When given to pregnant rabbits, the drug increased the risk of miscarriage. Trilipix did not increase the risk of birth defects or other problems. However, when a similar medication (
fenofibrate) was given to pregnant animals, the following problems occurred:
- Delayed labor and delivery
- Increased risk of miscarriages
- Low birth weight
- Increased risk of spina bifida
- Decreased newborn survival
- Increased risk of various deformities.
Because Trilipix is similar to
fenofibrate, similar problems would be expected to occur. However, it is important to note that animals do not always respond to medicines 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 woman outweigh any possible risks to the unborn child.
