Thank you for inviting me to talk with you about FDA’s new prescription medicine labeling system which provides information on the benefits and risks of using medicines during pregnancy and breastfeeding. This new system is one way that FDA works to support healthy pregnancies.
Why has the FDA decided to change their system of labeling prescription medications for use during pregnancy and breastfeeding?
FDA wants women and their health care providers to have useful and up-to-date information to help them make decisions about the benefits and risks of using prescription medicines during pregnancy and breastfeeding. The decision to change the labeling was based on several years of careful consideration and listening to healthcare providers, organizations and the general public about the pros and cons of the old system. We learned that the old system was somewhat confusing and not used consistently. The new Pregnancy & Lactation Labeling for prescription medicines will include more helpful information about a medication’s risks to pregnant women, the developing baby, and babies that are breastfed. Over-the-counter (also called, OTC) medicines that you get without a prescription are not affected by the new labeling rules.
How is the new labeling system different from the older system? What new information will I see on my prescription labels?
The biggest change for the new labeling system is that the letter categories are being phased out. The old system used five-letters (A, B, C, D and X) to categorize what is known about the risks of taking a medicine. Instead of the letters, the new labeling will have a description of the known risks in sentence format. The new labeling will also include information about the background risks of having a birth defect or miscarriage. Background risks are risks that every woman starts out with, even if she does not take any medication. Information about the risks of the medical condition on the pregnancy will be included, if known. In addition, there will be information on dose adjustments that may be needed in pregnancy.
FDA decided to eliminate the pregnancy letter categories because they were often misinterpreted as a grading system. Medications could have the same letter categories but have very different risks. People sometimes focused so much on the letters and did not focus on what the risk data actually said.
Will the new labels tell me if the medication will affect fertility?
The new labeling format includes a subsection called “Females and Males of Reproductive Potential”. This new section will include recommendations about birth control and pregnancy testing, if it’s a medication that should not be used in pregnancy because of a known or suspected risk. It will also include information about what is known about a medication’s effects on fertility if this information is available.
Some medications are more dangerous at certain times in pregnancy. Will the new labeling provide specific information for each trimester of pregnancy?
If there is information about effects in a specific trimester, it will be included in the labeling. The labeling will also include medical and disease factors that should be considered.
I’m breastfeeding. How can I find out if the medication I’m taking will be found in my breastmilk and if it will affect my baby?
The “Lactation” subsection will provide information, when it is known, about the amount of medication that is transferred into breastmilk and potential effects on the breastfeeding infant.
Will it be clear when a medication should be completely avoided during pregnancy or breastfeeding?
If a medicine should not be used during pregnancy or breastfeeding, this information will be clearly stated in the labeling. If there are ways to minimize exposure to the breastfed infant, this information will be included as well.
When can I expect to see these changes?
The changes have already started. The new prescription labeling system went into effect on June 30, 2015. New prescription medications approved on or after that date will immediately have the new format. For products approved on or after 2001, but prior to 2015, the changes will occur over the next several years. Some products are not required to change to this new format but all prescription medications will be required to remove the pregnancy letter category.
The risk information included in drug labeling often comes from research. How can I participate in research?
The new labeling will include information about pregnancy exposure registries. A pregnancy exposure registry is a study that collects health information from women who take prescription medications or receive vaccines when they are pregnant. There are registries for a number of medications and vaccines. By signing up for a pregnancy exposure registry, you can help other pregnant women and prescribers find out more about the safety of medicines used during pregnancy.
If there is a pregnancy exposure registry available for a medication, you will see contact information in the medication labeling. FDA’s Office of Women’s Health keeps a web listing of registries that you can search by medication name or medical condition. Here’s the link: www.fda.gov/pregnancyregistries
In addition to the research information that will be included in the prescription medication labeling, FDA has information on the participation of women in clinical trials. FDA is also participating in a multi-Agency task force to address the participation of pregnant and lactating women in research.