This article explains how the U.S. Food and Drug Administration (FDA) requires medications to be labeled concerning safety of use during pregnancy and breastfeeding – and if the first half of that sentence makes you want to fall asleep, please bear with me!! I totally understand how the nitty gritty of medication labeling standards might seem like it would bore you to tears! However, for women living with chronic illnesses…who may wish to become pregnant or breastfeed their babies, I think these changes actually represent a very exciting development!
The FDA provides labeling standards to help doctors and patients understand the potential risks of medication use during pregnancy and breastfeeding. Under the old labeling standard, each type of medication was classified into a pregnancy category: A, B, C, D, or X. These categories were intended to show the amount of data available for risk assessment, but the letter labels were often misinterpreted by patients as a safety grading system.
On December 3, 2014, the FDA issued a final rule setting new standards for labeling medications to indicate the risk of their use during pregnancy and breastfeeding. The new rule took effect as of June 30, 2015. All newly approved medications are required to use the new labeling standards, while previously approved medications are switching gradually.
This article explains the FDA’s new system for labeling medications to indicate their safety during pregnancy and breastfeeding:
New FDA Pregnancy Labeling Standards – Not As Boring As It Sounds!!
RheumatoidArthritis.net
Additional Resources:
Pregnancy and Lactation Labeling (Drugs) Final Rule (U.S. Food & Drug Administration)
