The FDA is implementing new labeling on medications
Women and their physicians will get more useful information over the next few years about the effects of medicines during pregnancy and breastfeeding.
The improvements will replace the decades-old labeling system currently in use and implement new requirements by Food and Drug Administration (FDA) regarding labeling information for prescription drugs and biological products. The changes, which will take a few years to roll out, will include major revisions in the subsections about 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:
Women take an average of three to five medications during pregnancy.
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.
New health problems may begin or old ones may get worse during pregnancy, requiring treatment.
A woman’s body changes throughout her pregnancy, which may affect the medication dose she needs.
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 might affect the infant.
The new labeling will also include a subsection called “Females and Males of Reproductive Potential,” which will provide a consistent location for relevant information about pregnancy testing, birth control and a medication’s effect on fertility.
“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,” Dr. Kweder says.
Until now, FDA categorized the risks of taking a medication during pregnancy under a five-letter system (A, B, C, D and X) based on what was known about that product. But users complained that the letter system was often confusing. “The revised labeling will change that,” Dr. Kweder says. “Now doctors will have up-to-date and well-organized information on pregnancy and lactation. They will be in a better position to help their patients make critical decisions.”
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.
Deciding which drug to take should be discussed with your doctor, but the new FDA rule helps remove some of its uncertainties. “The greatest benefit to patients is that these changes will result in better-informed prescribing based on the latest scientific information for thousands of medical products,” Dr. Kweder says. “Our goal is to empower health professionals and patients so that women can have confidence in treatment decisions for themselves and their families.”