Prograf and Pregnancy

Giving high doses of Prograf to pregnant animals appeared to increase the risk for miscarriage and fetal birth defects. Although this medicine has not been extensively studied in pregnant women, 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 Prograf?

Prograf® (tacrolimus) is a prescription anti-rejection medication used after certain transplant surgeries to prevent the body from rejecting the transplanted organ. Based on the results of animal studies, this medication may not be safe for use during pregnancy.
 

What Is Pregnancy Category C?

Prograf 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.
 
Prograf has been studied in pregnant rats, rabbits, and mice. In these studies, Prograf increased the risk for miscarriage when given to pregnant animals at doses high enough to cause side effects in the mother animals. The drug also caused fetal birth defects, including heart, bone, and gallbladder problems, when given in high doses to pregnant rats and rabbits.
 
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 Prograf, 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.
 
Although Prograf has not been adequately studied in pregnant women, there have been reports of women who took the drug during pregnancy. In some of these reports, the infants were born with kidney problems and increased blood potassium levels (hyperkalemia). However, in other reports no problems were observed in the newborn babies.
 
It should be noted that women who take immunosuppressants, including Prograf, after a transplant appear to have an increased risk for premature delivery, as well as poor growth of the baby while in the womb. However, it is difficult to know for certain whether the premature delivery and poor growth are caused by the medications, other medications, the women's underlying medical problems, or something else.
 
Pregnancy and Pain

Prograf Medication Information

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