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

Sep 23, 2015

During pregnancy, women try to consider not only their own well-being, but also 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:

  • Category A.Adequate and well-controlled studies have failed to demonstrate a risk to the fetus in the first trimester of pregnancy (and there is no evidence of risk in later trimesters). Example: prenatal vitamins
  • Category B.Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women. Example: Tylenol (acetaminophen), Claritin(loratadine)
  • Category C.Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks. Example: Sudafed (pseudoephedrine)
  • Category D.There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks. Example: tetracycline, aspirin
  • Category X.Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits. Example: Coumadin (warfarin), Accutane (isotretinoin)

Why did the change take 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:

  • Pregnancy
  • Lactation
  • Females and Males of Reproductive Potential

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

  • Risk summary
  • Clinical considerations
  • Data

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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