What are "Pregnancy Category C" medications?

The FDA has created guidelines for drug companies to follow in regards to labeling medications and their affects on reproduction and pregnancy. According to these guidelines a category C medication is one in which the risk to the pregnancy cannot be ruled out. For medications in this category, adequate, well-controlled human studies are lacking, and animal studies have shown a risk to the fetus or are lacking as well.
There is a chance of fetal harm if the drug is administered during pregnancy; but the potential benefits may outweigh the potential risk. Many medications pregnant women use fall into this category, therefore the woman and her healthcare provider need to evaluate the benefits of the medication against the possible risk to the fetus.

Kathy Snider
Neonatal Nursing

In 1979, the U.S. Food and Drug Administration (FDA) provided us with a classification system that described the fetal risks associated with certain drugs. The U.S. FDA has issued the following definition for the pregnancy category C:

“Pregnancy 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.”

For pregnant women, this means that any medication that has a Pregnancy Category C listed is not likely to be prescribed by your health care provider, as it may cause harm to your unborn baby.



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Important: This content reflects information from various individuals and organizations and may offer alternative or opposing points of view. It should not be used for medical advice, diagnosis or treatment. As always, you should consult with your healthcare provider about your specific health needs.