In just a couple months, the new U.S. Food and Drug Administration (FDA) labeling rules for drug use during pregnancy will be enacted. The rule was published on December 3, 2014, and the administration hopes that the new content and formatting requirements for drug labeling will provide more consistent information about the risks and benefits of prescription drugs used during pregnancy and breastfeeding.
The FDA states that pregnant women take an average of three to five prescription drugs throughout pregnancy. These drugs are currently labeled with product letter categories that classify the risks of using the drugs. The categories – A, B, C, D and X – will be phased out on June 30, 2015 and replaced with more detailed subsections that provide real-world contexts for drug use. The subsections are listed as follows:
- This subsection will describe dosing requirements and risks to developing fetuses.
- This subsection provides information on how the drug interacts with breastmilk and whether it poses a risk to the newborn.
- Females and Males of Reproductive Potential. This subsection includes information about pregnancy testing, contraception and infertility as it relates to a drug.
It is hoped that these new labeling rules will give expectant mothers and their doctors more accurate information about drug use during pregnancy and prevent birth injuries as a result.
Farrell & Patel – Birth Injury Law Firm
Source: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm425317.htm
