Better Drug Labeling Is Nigh

Did you know that the average pregnant women takes 3-5 medications during pregnancy? I did not know that!

So it's with great pleasure we announce that the FDA wants to update drug labels so expecting mothers can better make decisions about ingesting pharmaceuticals. In short, the FDA wants to create drug labels that are more informative and easier to read.

Until now, the US Food and Drug Administration categorized the risks of taking a drug or biological product during pregnancy under a five-letter system (A, B, C, D and X) based on what was known about that product. But comments received by FDA showed that the letter system was often confusing because it was overly simplistic, and did not adequately reflect available information. This system, the FDA determined, could lead to false assumptions about medications based on their category.

The revised labeling is expected to change that.

Look of the Revised Drug Labeling

The revised labeling will replace the old five-letter system with more helpful information about a medication’s risks to the expectant mother, the developing fetus and the breastfed infant. New labeling will also include contact information for pregnancy exposure registries that collect and maintain data on the effects of medications used by pregnant women.

What’s Next

Companies will have to remove the pregnancy letter categories from the labeling for all prescription drugs and biological products and, for many of them, revise the labeling with updated information. This is a large undertaking that will take several years.

Women and their health care providers can look forward to getting more useful and up-to-date information over the next few years about the effects of medicines during pregnancy and breastfeeding.

"FDA wants pregnant and breastfeeding women and their health care providers to benefit from the most useful and latest information about their prescription medicines," says Sandra Kweder, M.D., deputy director of FDA's Office of New Drugs.

She says pregnant women and health care providers need this information because:

  1. Women take an average of three to five medications during pregnancy
  2. Many pregnant women have chronic conditions—such as asthma, high blood pressure, depression and diabetes—that require them to continue taking medications they were on before pregnancy
  3. New health problems may begin or old ones may get worse during pregnancy, requiring treatment
  4. A woman’s body changes throughout pregnancy, which may affect medication doses needed
  5. The revised labeling will include more information on whether medication gets into breast milk, and—based on how much of it is present—how it can possibly affect the infant

"For medications that may cause infertility or present risks in pregnancy, the revised labeling will include information to be considered when deciding such issues as birth control or planning a pregnancy," Kweder says.

This article appears on FDA’s Consumer Updates page, which features the latest on all FDA-regulated products.

Kathleen HurleyFDA, labels