Oh Baby! FDA Issues New Pregnancy Drug Labeling System

Do you prescribe category C medications to pregnant women? These medications fall into that frustrating grey area where sometimes the medication may be a safe option for pregnant women and other times it may not be the best choice. Not to mention, it can be difficult to find relevant information on a medication’s safety status when it comes to breastfeeding and fertility. So, the FDA is taking action to change this age-old lettering classification system.

As a nurse practitioner, I’m frequently frustrated by the current pregnancy risk classification system. Certain antibiotics, for example, are safe in some trimesters of pregnancy but not others. So, what do I prescribe for this pregnant woman with a UTI? A simple indication of “pregnancy category C” doesn’t help much.

The current drug classification system is archaic having been the standard since the 1970’s. The newer classification system aims to give women and their healthcare providers clearer and more substantial information about the risks associated with taking certain medications while pregnant or breastfeeding. The current system of classifying medications as Category A, B, C, D or X is too simplistic. So, changes are underway. Here’s what nurse practitioners need to know about the new labeling system.

Why is this new classification system important?

There are more than 6 million pregnancies each year in the United States. On average, pregnant women take three to five prescription medications during pregnancy. These medications may be necessary to treat chronic medical conditions like asthma or hypertension or manage complications that arise as a result of pregnancy itself.

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Presenting information regarding medication use in pregnancy in a clear, complete manner gives patients and providers the information they need to make informed decisions when it comes to the care of pregnant women.

How will pregnancy and breastfeeding risks and considerations be presented under the new system?

The new labeling system includes “risk summaries” rather than “pregnancy categories”. The three new risk areas are as follows:

  • Pregnancy: This subsection will include information relevant to use of medications in pregnant women. It is to include dosing considerations, information about potential risks to the developing fetus, and requires information about whether a registry exists to collect information about pregnant women using the drug.
  • Lactation: The lactation subsection will discuss information about using the medication while breastfeeding. It includes data on how the medication affects breast milk production, how much medication passes into the breast milk, and potential effects on the breastfed child.
  • Females and Males Reproductive Potential: This subsection includes information about infertility and recommendations for contraceptive use while taking the medication.

The “Pregnancy” and “Lactation” subsections will also contain three subheadings, “risk summary”, “clinical considerations” and “data” to help organize relevant information.

When will I notice medication labels changing?

Don’t expect to notice these new medication labels right away. The FDA’s improved labeling system is mandatory only for new drugs effective June 30, 2015. Previously approved medications will gradually adopt the new labeling system over the next few years. Over the counter medications are not affected by the new ruling, so don’t expect changes when it comes to these labels.

The new beefed-up medication labeling system will help pregnant and breastfeeding mothers and their healthcare providers better weigh the risks and benefits of taking medications while pregnant. Readily available, more detailed information will take the guesswork out of many clinical decisions when it comes to treating women.


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