Beyond ABC: FDA finalizes labeling rules for pregnant, lactating women
- The FDA has finalized new rules on drug labeling as it relates to pregnant or lactating women, and men interested in reproduction.
- The new rules replace a letter based system used to classify risk of medications in pregnant or lactating women.
- There are over 6 million pregnancies in the US each year. Pregnant women take an average of three to five prescription drugs during pregnancy.
The old system or classifying medication risk during pregnancy left a lot of room for interpretation. Under the old system, drugs could be labeled as category A,B,C,D and X, with A being safe and X being deadly to the fetus. While many would say that the most ideal approach would be to avoid medications during pregnancy, that's not practicable or medically appropriate in many cases. Often women have preexisting chronic medical conditions, such as asthma, which must be treated, or they develop an acute condition during pregnancy.
The new system provides more guidance, with the use of three subsections, including pregnancy, lactation, and females and males of reproductive potential. The information provided is detailed, including information about how pregnant women are affected biologically by certain drugs, the amount of a drug that gets into breast milk and adverse reactions common in pregnant women.