FDA Enforces New Drug Safety Labeling System for Pregnant Women

A new labeling system for prescription drugs will take effect in June, according to the U.S. Food and Drug Administration (FDA), marking a radical change in the information available to doctors when prescribing medications to pregnant patients.

When you look at the vast amount of chronic medical conditions women deal with today — from depression to diabetes, hypertension to epilepsy and asthma — it’s not surprising that, according to the Centers for Disease Control and Prevention (CDC), close to 90 percent of all women are on at least one medication or over-the-counter drug. A good percentage of those women are actually on multiple medications, with those numbers constantly increasing.

This is the first revision the traditional A-X grading system has seen since 1979. A grade of A indicates the drug is considered benign when it comes to adverse effects in fetal development, while an X means it’s off limits to expectant mothers. The new labeling system will provide up-to-date technical information based on quantities of medicine as it relates to adverse effects on the fetus, breast-feeding and fertility.