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When Neoral was given in high doses to pregnant rats and rabbits, the drug appeared to cause miscarriages and low fetal weights. Although this medicine has not been adequately studied in pregnant humans, it is classified as a pregnancy Category C medicine. This means that the drug may not be safe for use during pregnancy and should only be used when the benefits outweigh the risks.

Can Pregnant Women Take Neoral?

Neoral® (cyclosporine) is a prescription medication approved for use in severe cases of psoriasis and rheumatoid arthritis, when certain other medicines have not adequately treated the condition. It is also approved to prevent organ transplant rejection after a kidney, liver, or heart transplant. Based on the results of animal studies, this medication may not be safe for use during pregnancy.

What Is Pregnancy Category C?

Neoral is classified as a pregnancy Category C drug. 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 adequately studied in pregnant humans but have caused fetal harm in animal studies.
In addition, medicines that have not been studied in any pregnant women or animals are automatically given a pregnancy Category C rating.
Neoral has not been adequately studied in pregnant women. In animal studies, the drug did not appear to increase the risk for birth defects. However, it did cause miscarriages and low fetal weights when given to pregnant rats and rabbits in doses high enough to harm the pregnant animals.
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, including Neoral, may be given to a pregnant woman if her healthcare provider believes that the benefits to the woman outweigh any possible risks to her unborn child.
Based on reports of pregnant women who took Neoral throughout pregnancy, the medicine may increase the risk for premature delivery and low birth weight. In the majority of these reports, the women were taking Neoral to prevent transplant rejection after an organ transplant. Therefore, it can be difficult to know whether the problems that occurred during pregnancy were caused by Neoral or the condition being treated.
Written by/reviewed by:
Last reviewed by: Kristi Monson, PharmD;
Last updated/reviewed:
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