FDA enforces new drug safety labeling system for pregnant women
A new drug safety 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.
The reality is, doctors can’t just say no to medications anymore, because many conditions moms face could have adverse effects on their unborn child if they’re not treated. But now, rather than relying on an oversimplified letter grade, doctors and patients will have the capability of analyzing the data and discussing what the risk-to-benefit ratios are in prescribing a drug during pregnancy. This is quite important because we still have medications which are contraindicated in the first trimester, but not later in the pregnancy, and some that are fine early on, but can be detrimental as a woman approaches delivery.
The increase in technical data available to health care professionals may also take into account the physiology of the patient during pregnancy, such as an increase in kidney function, which is an important part of prescribing to pregnant women.
The bottom line is this: As the challenges of pregnancy continue to grow with more and more women trying to conceive, everything has to be taken into account and by revamping these guidelines, the FDA is taking a step in the right direction when it comes to drug safety labeling and delivering healthy babies.