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Hi, Denell, and welcome to EmpowHer! Thank you so much for your question.

Here are some things I've found out about Asacol.

The drug is in the FDA's Pregnancy Category B for drugs, which means that it should not harm an unborn baby. However, please ask your doctor whether she/he will want you to switch when the baby is born, because the drug does get into your breast milk and can affect a nursing infant.

Here is the drugs.com page on Asacol:

http://www.drugs.com/asacol.html

I was wondering a little more about what "Pregnancy Category B" means. Here's what I found.

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 B is given to medicines that have NOT been studied in pregnant humans but do not appear to cause harm to the fetus in animal studies.

Here's that explanation:

http://colitis.emedtv.com/asacol/asacol-and-pregnancy.html

The summary of the pregnancy categories for drugs are as follows:

Category A: Studies in humans have demonstrated no risk to the fetus.
Category B: Studies in animals have demonstrated no risk to the fetus, but there have not been studies done on humans. (Many, many drugs fall into this category.)
Category C: Animal studies have shown adverse effect on the fetus and there have been no human studies but in some cases the drug may still be beneficial.
Category D: There have been studies in humans that have shown adverse risk to the fetus but in some cases the drug may still be beneficial.
Category X: Studies in animals or humans clearly show that the risks outweigh the benefits.

I researched several sites on the pregnancy categories, and all of them rely on the particular health care provider to know his or her own patient and be able to assess the risk for that patient.

On one board, I found a woman whose OB/gyn and GI doctor both told her that it was safe during her pregnancy, but that it was also safer than risking a flare-up during pregnancy because of the risk of contaminating the fetus. Did your doctor speak of this at all?

Is this information helpful? Is there more I can find for you?

May 19, 2009 - 9:56am

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