In animal studies involving Agenerase and pregnancy, the medication increased the risk of miscarriages and bone problems. As a result, the FDA has classified it as a pregnancy Category C medication. However, if you are taking Agenerase and pregnancy occurs, your healthcare provider may have you continue taking it if the benefits to you outweigh the risks to your unborn child.
Agenerase and Pregnancy: An Overview
Agenerase® (amprenavir) is a prescription HIV medication. Based on animal studies involving Agenerase, the medication may not be safe for use during pregnancy. Agenerase oral solution (but not capsules) should never be taken during pregnancy.
Agenerase is no longer available in the United States. The manufacturer stopped making it due to low demand, since it has been largely replaced by fosamprenavir (Lexiva®), a similar medication.
Agenerase and 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.
In studies, giving Agenerase to pregnant rabbits increased the risk of miscarriages and bone 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 her healthcare provider believes that the benefits to the woman outweigh any possible risks to the unborn child.
Agenerase oral solution contains a large amount of propylene glycol, which can be toxic to developing fetuses. If you are pregnant, you should not take Agenerase oral solution. This warning does not apply to Agenerase capsules, however, which do not contain propylene glycol.
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