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Adequate studies on Isentress and pregnancy have not been performed, so it is not known if the drug is safe to take during pregnancy. Although the medication caused problems in animal studies, animals do not always respond to drugs in the same way as humans. Therefore, if you are taking Isentress and pregnancy occurs, your doctor will consider the benefits and risks in your particular situation.
Isentress and Pregnancy: An OverviewIsentress® (raltegravir) is a prescription HIV medication. Because it has not been adequately studied in pregnant women, it is not known if the drug is safe for use during pregnancy.
Isentress and Pregnancy Category CThe 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.
When given to pregnant rabbits, Isentress did not cause any problems. However, when given to pregnant rats, the drug increased the risk of extra ribs in the offspring.
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 her healthcare provider believes that the benefits to the woman outweigh any possible risks to the unborn child.