Pregnancy and Lactation: New FDA Rules Make It Easier to Know Which Drugs Are Safe

Roni Shye
Roni Shye, PharmD BCGP BCACP, is a licensed pharmacist in the states of Florida, Ohio, and Pennsylvania.
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During pregnancy, women try to consider not only their own well-being, but the welfare of their developing child. It is crucial to take into account what you are putting into your body during your pregnancy—and after, for those who decide to breast feed. Medications are no exception.

In 2015, FDA published a final rule setting standards for how information about the risks using medications during pregnancy and breast-feeding is presented in the labeling of all prescription drug products.

What were the old classifications of risk, and what do they mean?

The lettered categories for the risk associated with using a medication while pregnant were designated by the U.S. Department of Health and Human Services. Here’s a break down of the categories, what they mean, and examples of medications in each category:

Why did the change taking place?

The new labeling for pregnancy and lactation is meant to help healthcare providers make informed decisions about the benefits and risks of the medications they prescribe.

It will also make it easier to educate yourself and make responsible decisions for yourself and your children.

What is the new labeling like?

The old letter categories have been be replaced by three detailed sections describing the potential risks:

Both the pregnancy and lactation sections will be broken down even further into:

When will the new standards start being used?

The new standards went into effect on June 30, 2015.

Will this change how over-the-counter (OTC) medications are labeled?

No. OTC medications are not affected by the FDA ruling.

Want to find out more?

For more information on the Pregnancy and Lactation Labeling Final Rule from the FDA click here.

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