Prescription Medications and Pregnancy

FDA Pregnancy Categories for Prescription Medications

This system classifies the possible risks to a fetus when a specific medicine is taken during pregnancy. It is used for prescription medications only. The FDA has established the following five categories:
 
  • Pregnancy Category A
  • Pregnancy Category B
  • Pregnancy Category C
  • Pregnancy Category D
  • Pregnancy Category X.
     
The main difference between categories is whether or not there is reliable animal and/or human data, whether or not the data shows risk to the fetus, and the risk-to-benefit ratio for a woman and her fetus. The categories are defined as follows:
 
  • Category A: Medications with adequate studies in pregnant women that do not show evidence of risk to a fetus in the first trimester, as well as no evidence of risk in later trimesters. The possibility of medications in this category causing fetal harm appears nonexistent.
 
  • Category B: Medications that appear safe to the fetus in animal studies but have not been adequately studied in pregnant women. This category also includes medications that have caused problems in animal studies, but have been shown to be safe in pregnant women. A drug in this category may be given to a pregnant woman if the healthcare provider believes that the benefits to the woman outweigh the possible risks to the fetus.
 
  • Category C: Medications that appear to be unsafe to the fetus in animal studies but have not been studied in pregnant women. It also includes medications that have not been studied at all in pregnant women or animals. Many drugs are classified as Category C. A medication in this category may still be given to a pregnant woman if the healthcare provider believes that the benefits to the woman outweigh the possible risks to the fetus.
 
  • Category D: Medications that have shown clear evidence of risk to the fetus in studies of pregnant women, but have potential benefits that may justify their use despite the risks. It still may be acceptable for a pregnant woman to take a medication in this category if the healthcare provider decides the benefits to the woman outweigh the possible risks to the fetus, such as in the case of a life-threatening situation or for treatment of a serious disease for which safer medications are not an option.
 
  • Category X: Studies of the medication in animals or humans have shown problems to the fetus, or there is evidence of potential harm to the fetus based on human experience, or both. The risks of the medications in this category clearly outweigh any possible benefits to pregnant women. Drugs in this category should not be used in pregnant women.
 
It is important to note that animals do not always respond to medicines in the same way that humans do. Therefore, animal studies may not reflect the true risks (or lack of risks) in humans.
 
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Pregnancy Info

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