New Labeling Rules for Pregnancy and Breastfeeding Products

The FDA has issued new regulations for prescription drug and medical product manufacturers to better communicate potential risks to women who are pregnant or breastfeeding, and people who are concerned about fertility.

The new rule, according to an FDA news release, “sets standards for how information about using medicines during pregnancy and breastfeeding is presented in the labeling of prescription drugs and biological products. The new content and formatting requirements will provide a more consistent way to include relevant information about the risks and benefits of prescription drugs and biological products used during pregnancy and breastfeeding.”

Lots of people have been waiting a long time for the new rules. As explained on, for years the feds have used a letter category system – A, B, C, D and X – to describe the risks of drugs and biological products to pregnant women and their doctors. But it was a clunky, insufficient explanation of what patients needed to know in order to make informed decisions.

So the final rule is more complete. Instead of letters, there are narrative sections covering drug and biological product labels, which are broken down into sections on pregnancy, lactation and reproductive potential for both females and males.

“Prescribing decisions during pregnancy and lactation are individualized and involve complex maternal, fetal and infant risk-benefit considerations,” said Sandra Kweder in the news release. She’s deputy director of the Office of New Drugs in the FDA’s Center for Drug Evaluation and Research. “The letter category system was overly simplistic and was misinterpreted as a grading system, which gave an over-simplified view of the product risk. The new labeling rule provides for explanations, based on available information, about the potential benefits and risks for the mother, the fetus and the breastfeeding child.”

The subsection on pregnancy provides information about potential risks to a developing fetus, dosing information and information about pregnancy registries that might gather information on how the drug has affected pregnant women in the past.

Under lactation, there’s information about a drug’s potential effects on breast milk and children who drink it.

The fertility section concerns how a drug might affect contraception, fertility and pregnancy testing.

According to the FDA, there are more than 6 million pregnancies in the U.S. every year, and pregnant women take an average of three to five prescription drugs during pregnancy. Women who have asthma, high blood pressure or other conditions before they get pregnant might need to continue using prescription drugs to treat those conditions, so they need to know the risks.

Women also might need medicine to treat new or acute conditions that occur during pregnancy or breastfeeding.

As explained on AboutLawsuits, the new rule will affect many drug labels, some of which the FDA and scientists have struggled to classify in terms of their potential pregnancy risks. In many cases, the risks are inconclusive, or yet to be determined. One goal of the new regulation is to illuminate the state of this research.

According to AboutLawsuits, pregnant women and their doctors have been concerned primarily with two classes of drugs – antidepressants, and epilepsy drugs.

Many antidepressants are in a class of medications called selective serotonin reuptake inhibitors (SSRIs). They include Zoloft, Paxil, Prozac, Celexa, and Lexapro. Antidepressant side effects have been associated with an increased risk of birth defects, miscarriage and problems in the children, such as asthma and autism.

But if a woman is depressed and pregnant, and doesn’t treat her mental disorder, the fetus can be at risk as well as the woman.

Antiseizure meds like Depakote and Topamax also might pose a risk of birth defects and developmental problems. But not taking those drugs if you need them puts both mother and developing fetus at physical risk if epilepsy is uncontrolled during pregnancy.

So doctors and patients must figure out whether or not to use these drugs, and if so, how much and for how long. Letter designations aren’t helpful in this analysis, but a summary of the current data or research might be.

One supporter of the new rule is the nonprofit organization It provides evidence-based information to mothers, health-care professionals and the public about medications and other exposures during pregnancy and while breastfeeding.

“There will be a steep learning curve for clinicians and patients to feel comfortable with more detailed information as opposed to the simple letter category,” said Christina Chambers, director of UC San Diego’s Center for the Promotion of Maternal Health and Infant Development, where the organization conducts pregnancy studies. “The MotherToBaby toll-free service can help.”

You can receive a personalized risk assessment of drugs or other exposures from MotherToBaby’s expert phone counseling service at (866) 626-6847. The organization also is conducting pregnancy research studies about asthma, autoimmune diseases and vaccines. To learn more or to volunteer for a study, call the number above or link to and click on the “Research” tab.

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