Cholesterol Home > Lipofen and Pregnancy

Based on the results of animal studies, Lipofen may not be safe for women who are pregnant. When the drug was given to pregnant animals, a number of problems occurred, such as low birth weight, increased miscarriages, and delayed labor and delivery. If pregnancy occurs while you are taking Lipofen, talk to your healthcare provider immediately to discuss the potential risks.

Is Lipofen During Pregnancy Safe?

Lipofen® (fenofibrate) 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. Lipofen is a prescription medication used to treat unhealthy cholesterol and triglyceride levels.

Pregnancy Category C

The 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.
Lipofen has not been studied in pregnant women. In studies where pregnant animals were given Lipofen, problems included:
  • Low birth weight
  • Increased risk of spina bifida
  • Decreased newborn survival
  • Delayed labor and delivery
  • Increased risk of miscarriages
  • Increased risk of various deformities.
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 a healthcare provider believes that the benefits to the pregnant woman outweigh any possible risks to the unborn child.
Written by/reviewed by:
Last reviewed by: Kristi Monson, PharmD;
Last updated/reviewed:
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