Can Pregnant Women Take Juvisync?
Juvisync® (
sitagliptin/simvastatin) is a pregnancy Category X medicine. This means that this drug could potentially cause harm to an unborn child. Pregnant women should not take Juvisync. If you are pregnant or thinking about becoming pregnant, talk to your healthcare provider immediately.
Juvisync contains two different medications:
sitagliptin (
Januvia®) and
simvastatin (
Zocor®). Juvisync received a pregnancy Category X rating due to the simvastatin component.
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. Category X is given to medicines that show problems to the fetus in pregnant animal studies or in humans who have taken the medicine while pregnant. The use of a Category X medicine during pregnancy is not recommended.
Animal studies do not indicate that simvastatin increases the risk for birth defects. However, there have been occasional reports of problems, such as miscarriages and birth defects, in humans. It is unclear whether simvastatin actually increases the risk for such problems, as a certain number of miscarriages and birth defects will occur during pregnancies even if the mother does not take any medications.
The
effects of high cholesterol do not cause problems for many years or even decades. Therefore, if a woman refrains from taking a
cholesterol medicine while she is pregnant, it will have little impact on any long-term risks. Since there is little benefit and a very real risk during pregnancy, your healthcare provider will likely recommend that you not take Juvisync while pregnant.
For women who are thinking of becoming pregnant and are taking Juvisync, make sure to talk to your healthcare provider. Women who are pregnant (or trying to get pregnant) will probably be switched from Juvisync to Januvia (which contains sitagliptin only, without the simvastatin).
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