Juvisync and Pregnancy

It is generally recommended that women avoid taking Juvisync (sitagliptin/simvastatin) during pregnancy. There have been some reports of pregnant women taking this drug and experiencing miscarriages or birth defects. If you are taking this medicine and pregnancy occurs, you should contact your healthcare provider to discuss your options.

In September 2013, Merck & Co, Inc., announced that it would be discontinuing this medication. It is clear that this decision was made for business reasons, not for safety reasons.

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.
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Juvisync Medication Information

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