Baby your Baby: FDA Categories change to narrative statements

Baby your Baby: FDA Categories change to narrative statements

(KUTV) Women often use medications or have vaccines during pregnancy or breastfeeding.

The Food and Drug Administration's (FDA) old Pregnancy Categories (A, B, C, D, X) can have information that is difficult to understand or misleading. That is why in December 2014, the FDA released a new rule changing the Categories to narrative statements.

At MotherToBaby Utah, your local teratology information center, we have been using narrative risk statements, customized for each mom and her condition, for over 30 years. We encourage moms and healthcare providers to not use the FDA Categories or the internet. By the way, "teratology" is the study of non-genetic causes of birth defects or birth defects from a particular exposure during pregnancy.

The first thing to remember is that every pregnancy has about a 3% to 5% chance of having a birth defect, so we watch for patterns and risks in studies that are above that "background risk."

We'll look at 2 examples where the FDA Categories were misleading.

PHENERGAN, also known as promethazine, is a common medicine used to treat morning sickness. It has been labeled as a FDA Category C, meaning at the time the drug was marketed there were no controlled studies of the use of the medicine during pregnancy. However, promethazine has been on the market for almost 60 years and the post-marketing pregnancy studies have not shown an increased risk for birth defects. Manufacturers are only required to change the categories if there are problems with the medication.

PHENTERMINE is a weight-loss medication and sometimes women find out that they are pregnant while they are still using this medication. The FDA Category is X meaning it should be avoided in pregnancy because the risks outweigh the benefits. Limited studies do not show an increased risk for birth defects. However, the medication can increase maternal blood pressure and decrease maternal weight gain which can be of concern for both the mother and baby. So mom can talk to her provider about stopping phentermine when she finds out she is pregnant.

Also remember that pregnant women may need to continue to take a medication for a chronic condition, such as epilepsy, depression, or high blood pressure, since the risks of the condition may outweigh the risks of the medication.

If you have questions about your medications or exposures, you can talk to a teratogen information specialist about your specific situation and medications by visiting, call us at 801-328-2229, or send a text at 855-999-3525.