Afeditab and Pregnancy

It may not be safe for pregnant women to take Afeditab CR. When the medication was given to pregnant rabbits, mice, and rats, it increased the risk of miscarriages and birth defects. If you are taking Afeditab CR and pregnancy occurs, be sure to talk to your healthcare provider. He or she may still prescribe Afeditab CR if the benefits to you outweigh the risks to the unborn child.

 

An Overview of Afeditab and Pregnancy

For people who are pregnant, Afeditab CR® (nifedipine) may not be safe. This is based on animal studies that looked at the effects of Afeditab CR during pregnancy.
 

Afeditab and Pregnancy Category C

The U.S. Food and Drug Administration (FDA) uses a pregnancy 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. Also, medicines that have not been studied in any pregnant women or animals are automatically given a pregnancy Category C rating.
 
Afeditab CR was given a pregnancy Category C rating because of potential problems in animal studies. When given to pregnant rabbits, mice, and rats, Afeditab CR increased the risk of miscarriages and birth defects. These birth defects included problems with fingers or toes, rib deformities, and cleft palate.
 
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 may be given to pregnant women if the healthcare provider believes that the benefits to the pregnant woman outweigh any possible risks to the unborn child.
 
Afeditab CR is sometimes used to stop preterm labor, especially when other medications have failed. Afeditab CR helps to relax the smooth muscle of the uterus, stopping premature labor. Because Afeditab CR is not approved for treating preterm labor, this is considered an "off-label" use.
 
(Afeditab and Pregnancy Continued: Page 2)
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Written by/reviewed by: Kristi Monson, PharmD; Arthur Schoenstadt, MD
Last reviewed by: Kristi Monson, PharmD;