The FDA is amending its pregnancy labeling rules to remove the A, B, C, D, X pregnancy categories and replace them with a new structure. The new rule reorganizes existing subsections into "Pregnancy" and "Lactation" and adds a new section called "Females and Males of Reproductive Potential." This aims to provide more individualized risk assessments and access to safety information for prescribing drugs to pregnant and lactating women. However, transitioning to the new categories may be difficult for commonly used drugs approved before 2001 due to limited information.

1. Pregnancy, Lactation, and Reproductive Potential Labeling Rule
Chi Lan Trinh
Helen Tesfaye
I N T R O D U C T I O N
•7 out of 10 pregnant women in the US are prescribed at least
one medication2
•Safety in pregnancy data for only 10% of drugs
•Current pregnancy categories: A, B, C, D, X
• Results in under-treatment or lack of treatment
• Prescribers not assessing patient-specific risks and
benefits
• Inconsistencies among prescribers and other healthcare
providers
•FDA is amending the labeling content and format of
“Pregnancy,” “Labor and Delivery.” and “Nursing mothers”
subsections of the “Use in Specific Populations” section and the
“Precautions” section1
O B J E C T I V E
•Provide explanations and clarifications on the changing FDA
pregnancy categories
•Bring awareness to prescribers, healthcare professionals, and
patients regarding these changes
•Purpose of the new FDA ruling
•Provide insight into the most commonly used prescription
medications
A B S T R A C T
FDA’s pregnancy category has been used for more than three
decades in guiding prescription decisions in pregnant and
lactating women. This system does not take into account inter-
patient differences and does not prompt providers to review
medical literature, pregnancy registries, and package inserts prior
to prescribing. Additionally, the current labeling guidelines for
prescription drugs and biologic products makes accessing such
information a difficult task. The new labeling rule by FDA amends
the pregnancy categories – reorganizing the previously existing
subsections into “Pregnancy" and “Lactation,” and creating an
entirely new section for “Females and Males of Reproductive
Potential.” The goal is to resolve the previously mentioned
issues in prescribing medications to pregnant women. However,
we foresee potential issues in the implementation of these new
categories.
M E T H O D S
•FDA’s final ruling on “Content and Format of Labeling for
Human Prescription Drug and Biological Products;
Requirements for Pregnancy and Lactation Labeling” published
in the Federal Register on December 4, 2014
•Statistics about medication use in pregnancy was obtained
from CDC’s Treating for Two
•Drugs@FDA was used as a source for drug approval dates
D A T A
•Removal of A, B, C, D, X categories from human prescription
drug and biological product labeling.
•New labeling rule effective June 30, 20151
•Drugs approved after June 30, 2015 will use new drug labeling1
•Drugs approved on or after June 30, 2001 will be phased in
gradually1
•Drugs approved prior to June 30, 2001 – voluntary
•Commonly prescribed drugs during pregnancy in the past 30
days: Levothyroxine, Antibiotics, Insulin, Albuterol,
Promethazine, Cetirizine, Montelukast, Budesonide2
R E S U L T S
•All of the most common drugs prescribed to pregnant women in
the past 30 days and many of the top 200 drugs were approved
prior to June 30, 2001
•New ruling’s focus is limited to prescribers
•New labeling rule takes into account inter-patient differences and
assists in providing individualized care
•Ready access to information on package insert for drugs
approved after June 30, 2015
•Labeling will be more informative and accurate, and should be
continuously updated when new human data becomes available
C O N C L U S I O N S
•Prescribers cannot determine treatment simply based on a letter
• Prescribers required to thoroughly research medication and
safety data during pregnancy
• More patient-specific
•Avoid under-treatment and lack of treatment in pregnant and
lactating women, as well as encourage providers and patients to
use pregnancy registries
•Healthcare providers may have difficulty transitioning between the
pregnancy category and the labeling rule especially for common
drugs approved prior to June 30, 2001
•Limited time during visits to healthcare professionals
• Potential obstacle in utilization of new categories
R E F E R E N C E S
•1
”Content and Format of Labeling for Human Prescription Drug
and Biological Products; Requirements for Pregnancy and
Lactation Labeling.” Federal Register. Web. 20 Mar. 2015.
<https”www.federalregister.gov/articles/2014/12/04-
28242/pregnancy-lactation-and-reproductive potential-labeling-for-
human-prescription-drug-and-biological>
•2
“Data and Statistics.” Centers for Disease Control and
Prevention. Centers for Disease Control and Prevention, 19 Feb.
2014. Web. 26 Mar. 2015.
•<http://www.cdc.gov/pregnancy/meds/treatingfortwo/data.html>/
•3
“Drugs@FDA: FDA Approved Drug Products.” Drugs@FDA:Fda
Approved Drug Products. Web. 25 Mar. 2015.
<http://www.accessdata.fda.gov/scripts/cder/drugsatfda/>
•4
“Facts.” Centers for Disease Control and Prevention. Centers
forDisease Control and Prevention, 16 Jan. 2015. Web. 26 Mar.
2015.
<http://www.cdc.gov/pregnancy/meds/treatingfortwo/facts.html>/
Pregnancy
Labor and Delivery
Nursing Mothers
Pregnancy
•Includes labor and
delivery
Lactation
•Includes nursing
mothers
NEW!
Females and Males of
Reproductive Potential