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In clinical studies where pregnant rats were given tesamorelin (the active ingredient in Egrifta), the medication increased the risk for hydrocephaly, as well as decreased or absent skull formation in the fetal rats. Thus, the Food and Drug Administration has given Egrifta a pregnancy Category X rating, which means the risk always outweighs the benefits the drug might have. It should never be taken during pregnancy.
Is Egrifta Safe During Pregnancy?Egrifta™ (tesamorelin acetate) is a prescription medication approved to diminish excess abdominal body fat in people with human immunodeficiency virus (HIV) who also have a condition called lipodystrophy. This medication is not safe for use during pregnancy. Women who are pregnant or who could become pregnant must not take Egrifta.
What Is Pregnancy Category X?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 X is given to medicines that show problems to the fetus in animal studies or in humans who have mistakenly taken the drug. The risks Category X drugs present clearly outweigh the benefits, and they should not be used in women who are or may become pregnant.
When tesamorelin (the active ingredient in Egrifta) was given to rats in early stages of pregnancy, it was shown to produce hydrocephaly (a serious condition involving fluid buildup in the skull that can lead to permanent brain damage) in the offspring. At lower doses, tesamorelin caused a delay of skull formation in rats.
If you become pregnant while taking Egrifta, stop taking the medication as soon as possible and tell your healthcare provider.