Cyclosporine and Pregnancy

Women who are pregnant may not be able to safely take cyclosporine. Although the potential risks have not been adequately studied, giving this drug to pregnant rats and rabbits resulted in miscarriages, low fetal weights, and delayed bone development. Due to the potential risks, pregnant women should only take this medication when the benefits outweigh the risks.

Can Pregnant Women Take Cyclosporine?

Cyclosporine (Gengraf®, Neoral®, Sandimmune®) is a prescription medication used to prevent transplant rejection in people who have had a heart, kidney, or liver transplant. It is also used to treat severe psoriasis and rheumatoid arthritis after other medications have failed. Based on the results of animal studies, cyclosporine may not be safe for use during pregnancy.
 

What Is Pregnancy Category C?

Cyclosporine 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.
 
Cyclosporine has not been adequately studied in pregnant women. In animal studies, the drug increased the risk for miscarriage when given to pregnant rats and rabbits. It also caused low fetal weights and delayed bone development.
 
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 cyclosporine, 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 reported outcomes of women who took cyclosporine during pregnancy, the medicine may increase the risk for premature birth and low birth weight. In the majority of these reports, the women were taking the medicine after an organ transplant and most of them took the medicine throughout their pregnancy. Therefore, it can be difficult to know whether the problems that occurred during pregnancy were caused by cyclosporine, other medications, the women's underlying medical problems, or even something else.
 
It should be noted that other immunosuppressant medications have also been associated with premature delivery when given to pregnant women who are organ transplant recipients.
 
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