Gengraf and Pregnancy

Although the FDA has assigned a pregnancy Category C rating to Gengraf (cyclosporine), this doesn't mean that a woman who is expecting a child cannot take it. The risks the medicine presents are not entirely clear. Gengraf may increase the risk for premature birth and low birth weight; however, if the benefits outweigh the risk, it may still be prescribed.

Can Pregnant Women Take Gengraf?

Gengraf® (cyclosporine) is a prescription medication used after kidney, liver, or heart transplantation to prevent the body from rejecting the transplanted organ. It is also used in severe rheumatoid arthritis and certain types of psoriasis. This medication may not be safe for use during pregnancy.
 

What Is 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 do appear to cause harm to the fetus in animal studies.
 
In addition, medicines that have not been studied in any pregnant women or animals automatically are given a pregnancy Category C rating.
 
In animal studies, Gengraf did not appear to cause birth defects when given to pregnant rats and rabbits. It did, however, increase the risk for miscarriage and cause low fetal weight at doses high enough to harm the pregnant rats and rabbits.
 
However, it is important to note that animals do not always respond to medicines the same way that humans do. Therefore, a pregnancy Category C medicine may be given to a pregnant woman if the healthcare provider believes that the benefits to the woman outweigh any possible risks to the unborn child.
 
This medicine has not been adequately studied in pregnant women. There have been reports, however, of women who took the medication throughout their pregnancy. Based on these reports, the drug may increase the risk for premature birth and low birth weight.
 
It should be noted that the majority of women in these reports were taking Gengraf after an organ transplant. Therefore, it can be difficult to know for certain whether the problems were caused by Gengraf or the condition being treated.
 
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