There are many prescription drugs that women should avoid while they are pregnant or breastfeeding. But many women need to take a medication while pregnant or breastfeeding and the labeling system currently in use is decades old and, worse, it is confusing.
The U.S. Food and Drug Administration (FDA) has announced that it is updating the way prescription drugs are labeled for use during pregnancy or while breastfeeding. Until now, the FDA used a system that labeled a drug A, B, C, D, or X based on what was known about any potential dangers during pregnancy. This system was over simplistic and confusing, and did not reflect newer information.
Information about how drugs affect a pregnancy or breast milk is important. Many women with chronic conditions such as asthma, high blood pressure, depression, and diabetes need to take medications during their pregnancy. The FDA notes that most women take at least one medication during pregnancy. The number of women who need to use four or more medications during pregnancy has doubled in the last 30 years.
"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, MD, deputy director of FDA's Office of New Drugs.
The new system will contain more useful information about a medication's risks to the expectant mother, the fetus, and the breastfed baby. It will contain more information on whether a given medication gets into a woman's breast milk, how much gets in, and whether that amount can possibly affect the child.
Another section of the new labeling will be called "Females and Males of Reproductive Potential." This subsection will provide a consistent location for relevant information about pregnancy testing, birth control and a medication's effect on fertility.
Companies that make prescription drugs will have to remove the old letter designation from their labeling. In some cases, they may need to revise their labeling with updated information.