by Heidi Green
May 29, 2008

Any woman who, when pregnant or breastfeeding, has had to talk to a doctor about medication (almost certainly asking “Will this hurt my baby?”) will be glad to hear this news. The Food and Drug Administration (FDA) is planning to overhaul its rules for prescription labeling. The proposed guidelines would ensure that labels provide physicians with clearer, more complete information about drug risks during pregnancy and breastfeeding.

The problem
Current labeling can be confusing. For almost 30 years, the FDA has used a pregnancy category system for prescription drugs. Since 1978, medications have been classified into five categories—A, B, C, D, and X—according to their risks when used during pregnancy. According to Rear Admiral Sandra Kweder, MD, of the FDA’s Center for Drug Evaluation and Research, that system “led to an inaccurate and overly simplified view of prescribing in pregnancy and the attendant risks” and was “very difficult to update” as new information became available.

The solution
Under the new plan, a drug’s physician labeling would have separate sections for pregnancy and breastfeeding.

The pregnancy section would include:

• Fetal risk summary, providing information about the effects of the drug on the fetus (as well as any infant’s overall risk of birth defect, to provide a context).
• Clinical considerations, detailing dosing, risks of not providing treatment, and complications.
• Data, providing additional information on the data used to develop the fetal risk summary and clinical considerations.

The lactation section would include:

• Presence in human milk, detailing whether the drug makes its way into the mother’s milk.
• Effects, providing information about the effects on the breastfed baby.
• Risk comparison, explaining how the risks of exposure to the medicine compare with the known benefits of breastfeeding.

Today, a physician looking at information about a drug might see its class. If the proposed regulations go into effect, a doctor will see a whole lot more “stuff!” In the end, patients are going to benefit.

For example, category X means that a drug is known to harm human fetuses. A drug receives this rating even if newer research shows that the fetus is only at risk during the first trimester. A physician looking at the X rating may unknowingly opt against using this drug, even if the patient is at a later stage in her pregnancy. Or animal studies may show that a drug has a sedative effect, but research might also show that such a small amount of the drug passes into a woman’s milk that there is no need for concern.

Making informed decisions about medications
Don’t expect your doctors to have access to this new information just yet. As is standard practice with such proposals, the FDA will accept public comments for 90 days. Then, it will revise its proposal. Once the final guidelines are adopted—and it seems a sure thing that something close to what has been proposed will eventually be adopted—all new drugs will be required to comply. Existing drugs will transition to the new format, but change will come slowly. Kweder says converting labels could take “a number of years.”

You can look forward to the day when all of this pro and con information will help mothers and their doctors make informed decisions about all available medications, but that day isn’t here yet.

In the meantime, use and encourage your health care providers to use resources like LactMed, Thomas Hale’s Medications and Mother’s Milk (for breastfeeding mothers), MedLinePlus, and PubMed.

Most importantly, continue to ask questions! “Will this hurt my baby?” “What are the risks if I take it?” “What are the risks if I don’t take it?” Ask and ask again, until you feel like you’ve learned all you can from the dialogue. As always, if something doesn’t sound right, consider getting a second opinion.